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Protocol summary
This is a single-blind randomized clinical trial to Evaluate the Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare. The patients suffer from chronic lung complications such as respiratory symptoms as well as some degree of lung injury in spirometry. Duration of the study is one year and the first 6 weeks are assigned to pulmonary rehabilitation program. The patients are allocated to intervention or control group. Medical assessments in both groups will be repeated three times: Baseline, the end of the six week rehabilitation program and at the end of the study. Medical evaluation includes physical examination, bodyplethysmography, DL CO, ergospirometry, measurement of strength and endurance of quadriceps muscle, 6MWT, body composition analysis, SGRQ questionnaire and HADS questionnaire.
Patients will attend 3 times per week for 6 weeks in outpatient pulmonary rehabilitation program. The rehabilitation program includes physical exercises and patient education. The control group will receive their usual treatment in the same time. The patients are questioned in terms of exacerbation and lung complications leading to hospitalization as well as drug consumption monthly during the year.
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This is a single-blind randomized clinical trial to Evaluate the Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare. The patients suffer from chronic lung complications such as respiratory symptoms as well as some degree of lung injury in spirometry. Duration of the study is one year and the first 6 weeks are assigned to pulmonary rehabilitation program. The patients are allocated to intervention or control group. Medical assessments in both groups will be repeated three times: Baseline, the end of the six week rehabilitation program and at the end of the study. Medical evaluation includes physical examination, bodyplethysmography, DL CO, ergospirometry, measurement of strength and endurance of quadriceps muscle, 6MWT, body composition analysis, SGRQ questionnaire and HADS questionnaire. Patients will attend 3 times per week for 6 weeks in outpatient pulmonary rehabilitation program. The rehabilitation program includes physical exercises and patient education. The control group will receive their usual treatment in the same time. The patients are questioned in terms of exacerbation and lung complications leading to hospitalization as well as drug consumption monthly during the year.
این مطالعه یک کارآزمایی بالینی تصادفی یک سویه کور برای ارزیابی تاثیر توانبخشی ریوی را بر کیفیت زندگی، وضعیت عضلات اسکلتی، وضعیت کارکرد ریوی و پیامدهای مشکلات ریوی در بیماران ریوی گاز خردل است.این بیماران دارای عوارض مزمن ریوی گاز خردل می باشند و علاوه بر تنگی نفس یافته های اسپیرومتری درجاتی از آسیب ریوی را نشان می دهد. مدت اجرای مطالعه یکسال می باشد که 6 هفته اول آن اختصاص به انجام برنامه توانبخشی ریوی دارد. بیماران بعد از اخذ رضایت آگاهانه ، باید در ویزیت غربالگری قبل از ورود به مطالعه حضور یابند و در صورت داشتن شرایط ورود به مطالعه در دو گروه مداخله و کنترل بصورت تصافی قرار گیرند. ارزیابی های پزشکی در هر دو گروه سه نوبت تکرار خواهند شد. ابتدای مطالعه ، پایان 6 هفته برنامه توانبخشی و در انتهای مطالعه. ارزیابی پزشکی شامل معاینه بالینی، بادی پلاتیسموگرافی، دی ال سی او، ارگواسپیرومتری،اندازه گیری قدرت و استقامت عضله چهارسرران، 6MWT، اندازه گیری ترکیب توده بدنی، اندازه گیری کیفیت زندگی توسط پرسشنامه SGRQ و تکمیل پرسشنامه HADS می باشند.
گروه مورد در یک برنامه توانبخشی بصورت سرپایی به مدت 6 هفته و هر هفته سه جلسه قرار خواهد گرفت. برنامه توانبخشی شامل تمرینات فیزیکی و آموزش خواهد بود. گروه کنترل نیز درمان معمول خود را دریافت خواهند کرد. در طول یکسال به فاصله هر ماه دو گروه از نظر حملات و عوارض منجر به بستری بیماری و همچنین میزان مصرف دارو مورد پرسش قرار می گیرند.
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این مطالعه یک کارآزمایی بالینی تصادفی یک سویه کور برای ارزیابی تاثیر توانبخشی ریوی را بر کیفیت زندگی، وضعیت عضلات اسکلتی، وضعیت کارکرد ریوی و پیامدهای مشکلات ریوی در بیماران ریوی گاز خردل است.این بیماران دارای عوارض مزمن ریوی گاز خردل می باشند و علاوه بر تنگی نفس یافته های اسپیرومتری درجاتی از آسیب ریوی را نشان می دهد. مدت اجرای مطالعه یکسال می باشد که 6 هفته اول آن اختصاص به انجام برنامه توانبخشی ریوی دارد. بیماران بعد از اخذ رضایت آگاهانه ، باید در ویزیت غربالگری قبل از ورود به مطالعه حضور یابند و در صورت داشتن شرایط ورود به مطالعه در دو گروه مداخله و کنترل بصورت تصافی قرار گیرند. ارزیابی های پزشکی در هر دو گروه سه نوبت تکرار خواهند شد. ابتدای مطالعه ، پایان 6 هفته برنامه توانبخشی و در انتهای مطالعه. ارزیابی پزشکی شامل معاینه بالینی، بادی پلاتیسموگرافی، دی ال سی او، ارگواسپیرومتری،اندازه گیری قدرت و استقامت عضله چهارسرران، 6MWT، اندازه گیری ترکیب توده بدنی، اندازه گیری کیفیت زندگی توسط پرسشنامه SGRQ و تکمیل پرسشنامه HADS می باشند. گروه مورد در یک برنامه توانبخشی بصورت سرپایی به مدت 6 هفته و هر هفته سه جلسه قرار خواهد گرفت. برنامه توانبخشی شامل تمرینات فیزیکی و آموزش خواهد بود. گروه کنترل نیز درمان معمول خود را دریافت خواهند کرد. در طول یکسال به فاصله هر ماه دو گروه از نظر حملات و عوارض منجر به بستری بیماری و همچنین میزان مصرف دارو مورد پرسش قرار می گیرند.
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We hypothesise that, as is the case in COPD patients, pulmonary rehabilitation will improve the health of this patient group.
We hypothesise that, as is the case in COPD patients, pulmonary rehabilitation will improve the health of this patient group.
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ما معتقدیم توانبخشی ریوی در جانبازان شیمیایی ریوی مانند بیماران COPD باعث ارتقای سلامت ایشان می شود.
ما معتقدیم توانبخشی ریوی در جانبازان شیمیایی ریوی مانند بیماران COPD باعث ارتقای سلامت ایشان می شود.
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We outline the protocol for an assessor blind, two-armed, parallel-design randomized controlled clinical trial
We outline the protocol for an assessor blind, two-armed, parallel-design randomized controlled clinical trial
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کارآزمایی بالینی دارای گروه کنترل با گروه های موازی، یک سویه کور و تصادفی شده
کارآزمایی بالینی دارای گروه کنترل با گروه های موازی، یک سویه کور و تصادفی شده
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The pulmonary rehabilitation, trial activities and other clinical services will be delivered in Tehran’s Khatam-ol-Anbia Hospital. This hospital is a sub-specialized centre equipped with specialized personnel and advanced equipment including a cardio-pulmonary rehabilitation hall.
The pulmonary rehabilitation, trial activities and other clinical services will be delivered in Tehran’s Khatam-ol-Anbia Hospital. This hospital is a sub-specialized centre equipped with specialized personnel and advanced equipment including a cardio-pulmonary rehabilitation hall.
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توانبخشی ریوی و کلیه فعالیتهای مرتبط با آن در بیمارستان خاتم الانبیای تهران انجام می شود.این بیمارستان، یک مرکز فوق تخصصی است و از پرسنل کار آزموده و تجهیزات پیشرفته از جمله سالن توانبخشی برخوردار است.
توانبخشی ریوی و کلیه فعالیتهای مرتبط با آن در بیمارستان خاتم الانبیای تهران انجام می شود.این بیمارستان، یک مرکز فوق تخصصی است و از پرسنل کار آزموده و تجهیزات پیشرفته از جمله سالن توانبخشی برخوردار است.
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The participants are chemical warfare victims who have been exposed to mustard gas, residing in Tehran and its suburbs with symptomatic lung disease. Inclusion criteria include, FEV1 < 80%, MRC dyspnoea score ≥ 3 .
Exclusion criteria; 1) any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis, 2) any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases, 3) the presence of other non-chemical related pulmonary diseases like asthma, 4) active malignancy 5) severe cognitive disorder and psychiatric disease that is associated with memory disorder.
The participants are chemical warfare victims who have been exposed to mustard gas, residing in Tehran and its suburbs with symptomatic lung disease. Inclusion criteria include, FEV1 < 80%, MRC dyspnoea score ≥ 3 . Exclusion criteria; 1) any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis, 2) any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases, 3) the presence of other non-chemical related pulmonary diseases like asthma, 4) active malignancy 5) severe cognitive disorder and psychiatric disease that is associated with memory disorder.
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شرکت کنندگان این مطالعه جانبازانی هستند که سابقه مواجهه با گاز خردل را دارند و دارای مشکلاتی ریوی بوده و در تهران و حومه آن زندگی می کنند.
معیارهای ورود به مطالعه: FEV1 < 80%, MRC dyspnoea score ≥ 3
معیارهای خروج از مطالعه:
1)هر نوع وضعیت بالینی که توانایی فرد در در شرکت در برنامه بازتوانی محدود کند مانند آرتریت ناتوان کننده
2)هر نوع وضعیت بالینی که ممکن است بیمار را در طول تمرینات ورزشی در معرض خطر قرار دهد مانند بیماریهای قلبی کنترل نشده
3)سایر بیماریهای ریوی غیر شیمیایی مانند وجود همزمان بیماری آسم
4)سرطان فعال(بدخیمی درمان نشده یا تحت درمان در دو سال اخیر)
5)اختلال شناختی شدید و بیماری روانی که همراه با اختلالات حافظه باشد
شرکت کنندگان این مطالعه جانبازانی هستند که سابقه مواجهه با گاز خردل را دارند و دارای مشکلاتی ریوی بوده و در تهران و حومه آن زندگی می کنند. معیارهای ورود به مطالعه: FEV1 < 80%, MRC dyspnoea score ≥ 3 معیارهای خروج از مطالعه: 1)هر نوع وضعیت بالینی که توانایی فرد در در شرکت در برنامه بازتوانی محدود کند مانند آرتریت ناتوان کننده 2)هر نوع وضعیت بالینی که ممکن است بیمار را در طول تمرینات ورزشی در معرض خطر قرار دهد مانند بیماریهای قلبی کنترل نشده 3)سایر بیماریهای ریوی غیر شیمیایی مانند وجود همزمان بیماری آسم 4)سرطان فعال(بدخیمی درمان نشده یا تحت درمان در دو سال اخیر) 5)اختلال شناختی شدید و بیماری روانی که همراه با اختلالات حافظه باشد
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In addition to the usual treatment, the intervention group will receive pulmonary rehabilitation services. The pulmonary rehabilitation intervention will include a combination of physical exercises, educational programs and psychosocial support. The physical exercises will include endurance and strength components tailored to each individual’s conditions. Both the upper and lower limbs will be exercised, though with greater emphasis on the legs
In addition to the usual treatment, the intervention group will receive pulmonary rehabilitation services. The pulmonary rehabilitation intervention will include a combination of physical exercises, educational programs and psychosocial support. The physical exercises will include endurance and strength components tailored to each individual’s conditions. Both the upper and lower limbs will be exercised, though with greater emphasis on the legs
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در این گروه، شرکت کنندگان علاوه بر درمان های معمول خدمات توانبخشی ریوی را نیز دریافت می کنند.مداخله توانبخشی ریوی ترکیبی از تمرینات فیزیکی، برنامه های آموزشی و حمایتهای روانی اجتماعی خواهد بود.تمرینات فیزیکی شامل تمرینات قدرتی و استقامتی متناسب با وضعیت بیماران خواهد بود. این تمرینات شامل هم اندامهای فوقانی و هم تحتانی می شود ولی تمرکز اصلی بر اندام تحتانی می باشد.
در این گروه، شرکت کنندگان علاوه بر درمان های معمول خدمات توانبخشی ریوی را نیز دریافت می کنند.مداخله توانبخشی ریوی ترکیبی از تمرینات فیزیکی، برنامه های آموزشی و حمایتهای روانی اجتماعی خواهد بود.تمرینات فیزیکی شامل تمرینات قدرتی و استقامتی متناسب با وضعیت بیماران خواهد بود. این تمرینات شامل هم اندامهای فوقانی و هم تحتانی می شود ولی تمرکز اصلی بر اندام تحتانی می باشد.
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Primary endpoint will be change in cycle endurance time at 70% baseline exercise capacity at six weeks
Primary endpoint will be change in cycle endurance time at 70% baseline exercise capacity at six weeks
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متغیر پیامد اصلی، تغییر زمان آزمون استقامتی با دوچرخه بر مبنای 70% ظرفیت تمرینی پایه بعد از گذشت 6 هفته می باشد
متغیر پیامد اصلی، تغییر زمان آزمون استقامتی با دوچرخه بر مبنای 70% ظرفیت تمرینی پایه بعد از گذشت 6 هفته می باشد
General information
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Year
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year
No
Yes
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patients with history of sulfur mustard exposure
FEV1 lower than 80% predicted
MRC dyspnoea score ≥ 3
patients with history of sulfur mustard exposure FEV1 lower than 80% predicted MRC dyspnoea score ≥ 3
بیماران با سابقه مواجهه با گاز خردل گوگردی
FEV1 کمتر از 80% مقادیر تخمینی
شدت تنگی نفس بر مبنای MRC مساوی با بیشتر از 3 باشد
بیماران با سابقه مواجهه با گاز خردل گوگردی FEV1 کمتر از 80% مقادیر تخمینی شدت تنگی نفس بر مبنای MRC مساوی با بیشتر از 3 باشد
any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis
any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases
the presence of other non-chemical related pulmonary diseases like asthma
active malignancy
severe cognitive disorder and psychiatric disease that is associated with memory disorder
any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases the presence of other non-chemical related pulmonary diseases like asthma active malignancy severe cognitive disorder and psychiatric disease that is associated with memory disorder
هر نوع وضعیت بالینی که توانایی فرد در در شرکت در برنامه بازتوانی محدود کند مانند آرتریت ناتوان کننده
هر نوع وضعیت بالینی که ممکن است بیمار را در طول تمرینات ورزشی در معرض خطر قرار دهد مانند بیماریهای قلبی کنترل نشده
سایر بیماریهای ریوی غیر شیمیایی مانند وجود همزمان بیماری آسم
سرطان فعال(بدخیمی درمان نشده یا تحت درمان در دو سال اخیر)
اختلال شناختی شدید و بیماری روانی که همراه با اختلالات حافظه باشد
هر نوع وضعیت بالینی که توانایی فرد در در شرکت در برنامه بازتوانی محدود کند مانند آرتریت ناتوان کننده هر نوع وضعیت بالینی که ممکن است بیمار را در طول تمرینات ورزشی در معرض خطر قرار دهد مانند بیماریهای قلبی کنترل نشده سایر بیماریهای ریوی غیر شیمیایی مانند وجود همزمان بیماری آسم سرطان فعال(بدخیمی درمان نشده یا تحت درمان در دو سال اخیر) اختلال شناختی شدید و بیماری روانی که همراه با اختلالات حافظه باشد
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After selecting the participants according to the inclusion and exclusion criteria, baseline assessments will be performed .The participants will be randomized into two control and intervention groups. The random sequence will be determined from the randomization website (http://www.jerrydallal.com/random/permute.htm) in blocks of four
After selecting the participants according to the inclusion and exclusion criteria, baseline assessments will be performed .The participants will be randomized into two control and intervention groups. The random sequence will be determined from the randomization website (http://www.jerrydallal.com/random/permute.htm) in blocks of four
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بعد از انتخاب بیماران بر اساس ارزیابی های اولیه و معیارهای ورود و خروج از مطالعه، شرکت کنندگان به دوگروه شاهد و مداخله تقسیم می شوند. توالی تصادف سازی با کمک وب سایت (http://www.jerrydallal.com/random/permute.htm) در بلوک های چهارتایی انجام می شود.
بعد از انتخاب بیماران بر اساس ارزیابی های اولیه و معیارهای ورود و خروج از مطالعه، شرکت کنندگان به دوگروه شاهد و مداخله تقسیم می شوند. توالی تصادف سازی با کمک وب سایت (http://www.jerrydallal.com/random/permute.htm) در بلوک های چهارتایی انجام می شود.
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The technicians who are responsible for randomization , the assessors and the safety committee and data monitoring are blind to the study.The two groups are identified by letters A and B. In order to protect confidentiality in all stages of the trial, each participant will be assigned a unique identification code.
The technicians who are responsible for randomization , the assessors and the safety committee and data monitoring are blind to the study.The two groups are identified by letters A and B. In order to protect confidentiality in all stages of the trial, each participant will be assigned a unique identification code.
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تکنسینی که مسئول تصادفی سازی است ، ارزیابی کننده ها و کمیته ایمنی و نظارت بر داده ها نسبت به مطالعه کور هستند.دو گروه با حروف الف و ب مشخص می شوند و برای اینکه اطلاعات بیماران محرمانه باقی بماند به هر بیمار ، کد شناسایی داد می شود.
تکنسینی که مسئول تصادفی سازی است ، ارزیابی کننده ها و کمیته ایمنی و نظارت بر داده ها نسبت به مطالعه کور هستند.دو گروه با حروف الف و ب مشخص می شوند و برای اینکه اطلاعات بیماران محرمانه باقی بماند به هر بیمار ، کد شناسایی داد می شود.
Recruitment centers
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Name of recruitment center - English: Khatam Ol Anbia Hospital
Name of recruitment center - Persian: بیمارستان خاتم الانبیا
Full name of responsible person - English: Iraj Arabi MD.
Full name of responsible person - Persian: دکتر ایرج عربی
Street address - English: Khatam Ol Anbia Hospital, Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr St.
Street address - Persian: خيابان وليعصر، بالاتر از بلوار ميرداماد، خيابان رشيد ياسمي، بيمارستان تخصصي و فوق تخصصي خاتم الانبياء(ص)
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Khatam Ol Anbia Hospital
Name of recruitment center - Persian: بیمارستان خاتم الانبیا
Full name of responsible person - English: Iraj Arabi MD.
Full name of responsible person - Persian: دکتر ایرج عربی
Street address - English: Khatam Ol Anbia Hospital, Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr St.
Street address - Persian: خيابان وليعصر، بالاتر از بلوار ميرداماد، خيابان رشيد ياسمي، بيمارستان تخصصي و فوق تخصصي خاتم الانبياء(ص)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 9815733345
Phone: +98 21 8888 4040
Fax:
Email: info@khatamhospital.org
Web page address: http://www.khatamhospital.org/index.php
Name of recruitment center - English: Khatam Ol Anbia Hospital Name of recruitment center - Persian: بیمارستان خاتم الانبیا Full name of responsible person - English: Iraj Arabi MD. Full name of responsible person - Persian: دکتر ایرج عربی Street address - English: Khatam Ol Anbia Hospital, Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr St. Street address - Persian: خيابان وليعصر، بالاتر از بلوار ميرداماد، خيابان رشيد ياسمي، بيمارستان تخصصي و فوق تخصصي خاتم الانبياء(ص) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 9815733345 Phone: +98 21 8888 4040 Fax: Email: info@khatamhospital.org Web page address: http://www.khatamhospital.org/index.php
#2
Name of recruitment center - English: Sasan Hospital
Name of recruitment center - Persian: بیمارستان ساسان
Full name of responsible person - English: Ali Tavakoli Mehrgerdi MD.
Full name of responsible person - Persian: دکتر علی توکلی مهرجردی
Street address - English: No 43, Keshavarz Ave.
Street address - Persian: میدان ولیعصر - بلوار کشاورز - بعد از چهار راه فلسطین - شماره 43
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Sasan Hospital
Name of recruitment center - Persian: بیمارستان ساسان
Full name of responsible person - English: Ali Tavakoli Mehrgerdi MD.
Full name of responsible person - Persian: دکتر علی توکلی مهرجردی
Street address - English: No 43, Keshavarz Ave.
Street address - Persian: میدان ولیعصر - بلوار کشاورز - بعد از چهار راه فلسطین - شماره 43
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14154
Phone: +98 21 8896 5170
Fax:
Email: info@sasanhospital.com
Web page address: http://www.sasanhospital.com
Name of recruitment center - English: Sasan Hospital Name of recruitment center - Persian: بیمارستان ساسان Full name of responsible person - English: Ali Tavakoli Mehrgerdi MD. Full name of responsible person - Persian: دکتر علی توکلی مهرجردی Street address - English: No 43, Keshavarz Ave. Street address - Persian: میدان ولیعصر - بلوار کشاورز - بعد از چهار راه فلسطین - شماره 43 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14154 Phone: +98 21 8896 5170 Fax: Email: info@sasanhospital.com Web page address: http://www.sasanhospital.com
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Health Department of Foundation of Martyrs and Veterans Affairs
Name of organization / entity - Persian: معاونت بهداشت و درمان بنیاد شهید و امور ایثارگران
Full name of responsible person - English: Abd ol Reza Abbaspour MD.
Full name of responsible person - Persian: دکتر عبدالرضا عباسپور
Street address - English: Talebial Alley, Taleghani Street
Street address - Persian: خیابان طالقانی-کوچه طالبیان- ساختمان شهدای گمنام
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Health Department of Foundation of Martyrs and Veterans Affairs
Name of organization / entity - Persian: معاونت بهداشت و درمان بنیاد شهید و امور ایثارگران
Full name of responsible person - English: Abd ol Reza Abbaspour MD.
Full name of responsible person - Persian: دکتر عبدالرضا عباسپور
Street address - English: Talebial Alley, Taleghani Street
Street address - Persian: خیابان طالقانی-کوچه طالبیان- ساختمان شهدای گمنام
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +98 21 8831 3219
Fax:
Email: info@isaar.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Health Department of Foundation of Martyrs and Veterans Affairs Name of organization / entity - Persian: معاونت بهداشت و درمان بنیاد شهید و امور ایثارگران Full name of responsible person - English: Abd ol Reza Abbaspour MD. Full name of responsible person - Persian: دکتر عبدالرضا عباسپور Street address - English: Talebial Alley, Taleghani Street Street address - Persian: خیابان طالقانی-کوچه طالبیان- ساختمان شهدای گمنام City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +98 21 8831 3219 Fax: Email: info@isaar.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Other
other
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Janbazan Medical Engineering Research Center
Name of organization / entity - Persian: پژوهشکده مهندسی و علوم پزشکی جانبازان
Full name of responsible person - English: Mohamad Reza Sedighi Moghadam MD. MPH
Full name of responsible person - Persian: دکتر محمد رضا صدیقی مقدم
Position - English: researcher/general practitioner /MD. MPH
Position - Persian: محقق،پزشک عمومی -MPH
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17,Farokh Street,Moghadas Ardebili Street
Street address - Persian: تهران، خیابان مقدس اردبیلی، خیابان فرخ، شماره 17
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2241 5367
Mobile: +98 912 187 9803
Fax:
Email: moghadam_office@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Janbazan Medical Engineering Research Center
Name of organization / entity - Persian: پژوهشکده مهندسی و علوم پزشکی جانبازان
Full name of responsible person - English: Mohamad Reza Sedighi Moghadam MD. MPH
Full name of responsible person - Persian: دکتر محمد رضا صدیقی مقدم
Position - English: researcher/general practitioner /MD. MPH
Position - Persian: محقق،پزشک عمومی -MPH
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17,Farokh Street,Moghadas Ardebili Street
Street address - Persian: تهران، خیابان مقدس اردبیلی، خیابان فرخ، شماره 17
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1933934933
Phone: +98 21 2241 5367
Mobile: +98 912 187 9803
Fax:
Email: moghadam_office@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Janbazan Medical Engineering Research Center Name of organization / entity - Persian: پژوهشکده مهندسی و علوم پزشکی جانبازان Full name of responsible person - English: Mohamad Reza Sedighi Moghadam MD. MPH Full name of responsible person - Persian: دکتر محمد رضا صدیقی مقدم Position - English: researcher/general practitioner /MD. MPH Position - Persian: محقق،پزشک عمومی -MPH Latest degree: med_doctor Area of specialty/work: 030 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 17,Farokh Street,Moghadas Ardebili Street Street address - Persian: تهران، خیابان مقدس اردبیلی، خیابان فرخ، شماره 17 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1933934933 Phone: +98 21 2241 5367 Mobile: +98 912 187 9803 Fax: Email: moghadam_office@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Pateur Institute of Iran
Name of organization / entity - Persian: انستیتو پاستور
Full name of responsible person - English: Mostafa Ghanei MD.
Full name of responsible person - Persian: دکتر مصطفی قانعی
Position - English: Head of Institute, pulmonologist
Position - Persian: پزشک، فوق تخصص ریه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 12th Frvardin Street, Enghelab Square
Street address - Persian: میدان انقلاب-انتهای خیابان 12 فروردین
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +66 954321
Mobile: 00
Fax:
Email: mghaneister@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Pasteur Institute of Iran
Name of organization / entity - Persian: انستیتو پاستور
Full name of responsible person - English: Mostafa Ghanei MD.
Full name of responsible person - Persian: دکتر مصطفی قانعی
Position - English: Head of Institute, pulmonologist
Position - Persian: پزشک، فوق تخصص ریه
Latest degree: sub_specialist
Area of specialty/work: 0
Area of specialty/work title - English: respiratory diseases
Area of specialty/work title - Persian: بیماریهای تنفسی
Street address - English: 12th Frvardin Street, Enghelab Square
Street address - Persian: میدان انقلاب-انتهای خیابان 12 فروردین
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1234567890
Phone: +66 954321
Mobile: +98 912 320 9673
Fax:
Email: mghaneister@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: PateurPasteur Institute of Iran Name of organization / entity - Persian: انستیتو پاستور Full name of responsible person - English: Mostafa Ghanei MD. Full name of responsible person - Persian: دکتر مصطفی قانعی Position - English: Head of Institute, pulmonologist Position - Persian: پزشک، فوق تخصص ریه Latest degree: sub_specialist Area of specialty/work: 0 Area of specialty/work title - English: respiratory diseases Area of specialty/work title - Persian: بیماریهای تنفسی Street address - English: 12th Frvardin Street, Enghelab Square Street address - Persian: میدان انقلاب-انتهای خیابان 12 فروردین City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1234567890 Phone: +66 954321 Mobile: 00+98 912 320 9673 Fax: Email: mghaneister@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Janbazan Medical Engineering Research Center
Name of organization / entity - Persian: پژوهشکده مهندسی و علوم پزشکی جانبازان
Full name of responsible person - English: Mohamad Reza Sedighi Moghadam MD. MPH
Full name of responsible person - Persian: دکتر محمد رضا صدیقی مقدم
Position - English: researcher/general practitioner /MD. MPH
Position - Persian: محقق،پزشک عمومی -MPH
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17,Farokh Street,Moghadas Ardebili Street
Street address - Persian: تهران، خیابان مقدس اردبیلی، خیابان فرخ، شماره 17
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2241 5367
Mobile: +91 21879803
Fax:
Email: moghadam_office@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Janbazan Medical Engineering Research Center
Name of organization / entity - Persian: پژوهشکده مهندسی و علوم پزشکی جانبازان
Full name of responsible person - English: Mohamad Reza Sedighi Moghadam MD. MPH
Full name of responsible person - Persian: دکتر محمد رضا صدیقی مقدم
Position - English: researcher/general practitioner /MD. MPH
Position - Persian: محقق،پزشک عمومی -MPH
Latest degree: med_doctor
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No 17,Farokh Street,Moghadas Ardebili Street
Street address - Persian: تهران، خیابان مقدس اردبیلی، خیابان فرخ، شماره 17
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985946563
Phone: +98 21 2241 5367
Mobile: +98 912 187 9803
Fax:
Email: moghadam_office@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Janbazan Medical Engineering Research Center Name of organization / entity - Persian: پژوهشکده مهندسی و علوم پزشکی جانبازان Full name of responsible person - English: Mohamad Reza Sedighi Moghadam MD. MPH Full name of responsible person - Persian: دکتر محمد رضا صدیقی مقدم Position - English: researcher/general practitioner /MD. MPH Position - Persian: محقق،پزشک عمومی -MPH Latest degree: med_doctor Area of specialty/work: 030 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No 17,Farokh Street,Moghadas Ardebili Street Street address - Persian: تهران، خیابان مقدس اردبیلی، خیابان فرخ، شماره 17 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985946563 Phone: +98 21 2241 5367 Mobile: +91 2187980398 912 187 9803 Fax: Email: moghadam_office@yahoo.com Web page address:
Sharing plan
yes
yes
yes
yes
undecided
undecided
yes
yes
yes
yes
undecided
undecided
yes
yes
empty
The total potential data can be shared after unidentifiable people.
The total potential data can be shared after unidentifiable people.
empty
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است .
کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است .
empty
The start of the access period is one year after the publication of the results.
The start of the access period is one year after the publication of the results.
empty
شروع دوره دسترسی یک سال پس از چاپ نتایج است.
شروع دوره دسترسی یک سال پس از چاپ نتایج است.
empty
Data will only be available to researchers in universities and scientific centers .
Data will only be available to researchers in universities and scientific centers .
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داده ها فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
داده ها فقط برای محققین شاغل در موسسات دانشگاهی و علمی در دسترس خواهد بود.
empty
Applicants must announce their goals and plans on how to use the data to be decided on by case basis.
Applicants must announce their goals and plans on how to use the data to be decided on by case basis.
empty
درخواست کنندگان می بایست اهداف و برنامه خود را در مورد چگونگی استفاده از داده ها اعلام کنند تا بصورت موردی در مورد آن تصمیم گرفته شود.
درخواست کنندگان می بایست اهداف و برنامه خود را در مورد چگونگی استفاده از داده ها اعلام کنند تا بصورت موردی در مورد آن تصمیم گرفته شود.
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Janbazan Medical and Engineering Research Center (JMERC), NO.17, Farrokh St., Moghaddas Ardebily Ave., Chamran Highway, Tehran, Iran Tehran Iran
Phone: +98 2122415367
Fax: +98 2122418180
http://www.jmerc.ac.ir
Janbazan Medical and Engineering Research Center (JMERC), NO.17, Farrokh St., Moghaddas Ardebily Ave., Chamran Highway, Tehran, Iran Tehran Iran Phone: +98 2122415367 Fax: +98 2122418180 http://www.jmerc.ac.ir
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پژوهشکده مهندسی و علوم پزشکی جانبازان
تهران، بزرگراه شهید چمران، پمپ بنزین نمایشگاه بین المللی، خیابان یمن، خیابان مقدس اردبیلی، خیابان فرخ، پلاک 17
تلفن: 02122415367
فکس: 02122418180
http://www.jmerc.ac.ir
پژوهشکده مهندسی و علوم پزشکی جانبازان تهران، بزرگراه شهید چمران، پمپ بنزین نمایشگاه بین المللی، خیابان یمن، خیابان مقدس اردبیلی، خیابان فرخ، پلاک 17 تلفن: 02122415367 فکس: 02122418180 http://www.jmerc.ac.ir
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The request is submitted to the supervisor through JMERC. In case of initial agreement, the Reaserch Committee will make the final decision.
The request is submitted to the supervisor through JMERC. In case of initial agreement, the Reaserch Committee will make the final decision.
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درخواست از طریق پژوهشکده در اختیار سرپرست طرح قرار می گیرد. در صورت موافقت اولیه به کمیته پژوهش جهش تصمیم گیری نهایی ارسال خواهد شد.
درخواست از طریق پژوهشکده در اختیار سرپرست طرح قرار می گیرد. در صورت موافقت اولیه به کمیته پژوهش جهش تصمیم گیری نهایی ارسال خواهد شد.
Protocol summary
Study aim
We hypothesise that, as is the case in COPD patients, pulmonary rehabilitation will improve the health of this patient group.
Design
We outline the protocol for an assessor blind, two-armed, parallel-design randomized controlled clinical trial
Settings and conduct
The pulmonary rehabilitation, trial activities and other clinical services will be delivered in Tehran’s Khatam-ol-Anbia Hospital. This hospital is a sub-specialized centre equipped with specialized personnel and advanced equipment including a cardio-pulmonary rehabilitation hall.
Participants/Inclusion and exclusion criteria
The participants are chemical warfare victims who have been exposed to mustard gas, residing in Tehran and its suburbs with symptomatic lung disease. Inclusion criteria include, FEV1 < 80%, MRC dyspnoea score ≥ 3 .
Exclusion criteria; 1) any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis, 2) any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases, 3) the presence of other non-chemical related pulmonary diseases like asthma, 4) active malignancy 5) severe cognitive disorder and psychiatric disease that is associated with memory disorder.
Intervention groups
In addition to the usual treatment, the intervention group will receive pulmonary rehabilitation services. The pulmonary rehabilitation intervention will include a combination of physical exercises, educational programs and psychosocial support. The physical exercises will include endurance and strength components tailored to each individual’s conditions. Both the upper and lower limbs will be exercised, though with greater emphasis on the legs
Main outcome variables
Primary endpoint will be change in cycle endurance time at 70% baseline exercise capacity at six weeks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2016051127848N1
Registration date:2016-05-24, 1395/03/04
Registration timing:prospective
Last update:2018-02-07, 1396/11/18
Update count:1
Registration date
2016-05-24, 1395/03/04
Registrant information
Name
Mohamad Reza Sedighi Moghadam
Name of organization / entity
Chemical Warfare Victims Affairs Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8830 7246
Email address
drmoghaddam@jmerc.ac.ir
Recruitment status
Recruitment complete
Funding source
Foundation of Martyrs and Veterans Affairs
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Pulmonary rehabilitation effects on skeletal muscle condition, pulmonary function and quality of life in victims of chemical warfare
Public title
Pulmonary rehabilitation in chemical victims
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with history of sulfur mustard exposure
FEV1 lower than 80% predicted
MRC dyspnoea score ≥ 3
Exclusion criteria:
any type of debilitating clinical condition that prevents the patient from participating in the rehabilitation program –such as, arthritis
any type of clinical condition that will endanger the patient during the physical exercises –such as, uncontrolled cardiac diseases
the presence of other non-chemical related pulmonary diseases like asthma
active malignancy
severe cognitive disorder and psychiatric disease that is associated with memory disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants according to the inclusion and exclusion criteria, baseline assessments will be performed .The participants will be randomized into two control and intervention groups. The random sequence will be determined from the randomization website (http://www.jerrydallal.com/random/permute.htm) in blocks of four
Blinding (investigator's opinion)
Single blinded
Blinding description
The technicians who are responsible for randomization , the assessors and the safety committee and data monitoring are blind to the study.The two groups are identified by letters A and B. In order to protect confidentiality in all stages of the trial, each participant will be assigned a unique identification code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Ethics in Biomedical Research Foundation of Martyrs and Veterans Affairs
Street address
No 17,Farokh Street,Moghadas Ardebili Street
City
Tehran
Province
Tehran
Postal code
1985946563
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
87-E-R-102
Health conditions studied
1
Description of health condition studied
chronic respiratory disorders due to sulfur mustard inhalation
ICD-10 code
J68.4
ICD-10 code description
Chronic respiratory conditions due to chemicals, gases, fumes and vapors
Primary outcomes
1
Description
Endurance Time
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using an electronically braked cycle ergometer at 70% of Wmax to volitional exhaustion
Secondary outcomes
1
Description
Lung flows and volumes
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using body plethysmography
2
Description
single-breath diffusing capacity
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using DLCO
3
Description
Vo2max
Timepoint
before intervention
Method of measurement
by using ergospirometry
4
Description
Quadriceps muscle strength
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Biodex: Participants will perform 30 sequential volitional maximal contractions at an angular velocity of 90°/s, while seated upright and with the hip joint in 90° of flexion. Quadriceps muscle strength was defined as the highest peak torque (Newton-meter (Nm)).
5
Description
AT
Timepoint
before intervention
Method of measurement
by using ergospirometry
6
Description
O2 pulse
Timepoint
before intervention
Method of measurement
by using ergospirometry
7
Description
Quadriceps muscle endurance
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Biodex: Participants will perform 30 sequential volitional maximal contractions at an angular velocity of 90°/s, while seated upright and with the hip joint in 90° of flexion. Quadriceps muscle endurance was defined as the total amount of delivered work (Joules (J)) during the set of 30 repetitions
8
Description
Cross-sectional area of the rectus femoris (RFCSA)
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by Cross-sectional area of the rectus femoris (RFCSA) will be measured by B-mode ultrasonography using an 8 MHz 5.6 cm linear transducer, similar to the method of de Bruin et al
9
Description
FFM
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using single-frequency BIA (Bioelectrical Impedance Analyser)
10
Description
BMI
Timepoint
before intervention , 6th week, 12th month
Method of measurement
weight(kg)/height^2(m^2)
11
Description
Total distance walked during 6 minutes
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using 6MWT
12
Description
Anxiety and Depression
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using HADS
13
Description
quality of life
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using SGRQ
14
Description
Number of exacerbations (defined as episodes of increased respiratory symptoms requiring a change in medication)
Timepoint
monthly
Method of measurement
by asking the patient
15
Description
Number of hospitalization due to respiratory diseases
Timepoint
monthly
Method of measurement
by asking the patient and reviewing medical records
16
Description
GH
Timepoint
before intervention
Method of measurement
Lab Test
17
Description
IGF-1
Timepoint
before intervention
Method of measurement
Lab Test
18
Description
high sensitivity CRP
Timepoint
before intervention
Method of measurement
Lab Test
19
Description
Testosterone
Timepoint
before intervention
Method of measurement
Lab Test
20
Description
distance of daily walking
Timepoint
a week before intervention, 7th week and 12th month
Method of measurement
by using pedometer
21
Description
healthcare utilisation
Timepoint
at the end of study
Method of measurement
according to medical records
22
Description
dyspnea
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Borg Scale
23
Description
fatigue
Timepoint
before intervention , 6th week, 12th month
Method of measurement
by using Borg Scale
Intervention groups
1
Description
Intervention: Pulmonary rehabilitation will be a mix of aerobic endurance training and strength training as well as education in self management. Patients will attend 3 times per week for 6 weeks.
Category
Rehabilitation
2
Description
Control: usual treatment without any additional intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Ol Anbia Hospital
Full name of responsible person
Iraj Arabi MD.
Street address
Khatam Ol Anbia Hospital, Rashid Yasemi Street, Above Mirdamad Blvd, Vali-Ye-Asr St.
City
Tehran
Province
Tehran
Postal code
9815733345
Phone
+98 21 8888 4040
Email
info@khatamhospital.org
Web page address
http://www.khatamhospital.org/index.php
2
Recruitment center
Name of recruitment center
Sasan Hospital
Full name of responsible person
Ali Tavakoli Mehrgerdi MD.
Street address
No 43, Keshavarz Ave.
City
Tehran
Province
Tehran
Postal code
14154
Phone
+98 21 8896 5170
Email
info@sasanhospital.com
Web page address
http://www.sasanhospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Health Department of Foundation of Martyrs and Veterans Affairs
Full name of responsible person
Abd ol Reza Abbaspour MD.
Street address
Talebial Alley, Taleghani Street
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 8831 3219
Email
info@isaar.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Health Department of Foundation of Martyrs and Veterans Affairs
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Janbazan Medical Engineering Research Center
Full name of responsible person
Mohamad Reza Sedighi Moghadam MD. MPH
Position
researcher/general practitioner /MD. MPH
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 17,Farokh Street,Moghadas Ardebili Street
City
Tehran
Province
Tehran
Postal code
1933934933
Phone
+98 21 2241 5367
Fax
Email
moghadam_office@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Mostafa Ghanei MD.
Position
Head of Institute, pulmonologist
Latest degree
Subspecialist
Other areas of specialty/work
respiratory diseases
Street address
12th Frvardin Street, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+66 954321
Fax
Email
mghaneister@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Janbazan Medical Engineering Research Center
Full name of responsible person
Mohamad Reza Sedighi Moghadam MD. MPH
Position
researcher/general practitioner /MD. MPH
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 17,Farokh Street,Moghadas Ardebili Street
City
Tehran
Province
Tehran
Postal code
1985946563
Phone
+98 21 2241 5367
Fax
Email
moghadam_office@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
The start of the access period is one year after the publication of the results.
To whom data/document is available
Data will only be available to researchers in universities and scientific centers .
Under which criteria data/document could be used
Applicants must announce their goals and plans on how to use the data to be decided on by case basis.
From where data/document is obtainable
Janbazan Medical and Engineering Research Center (JMERC), NO.17, Farrokh St., Moghaddas Ardebily Ave., Chamran Highway, Tehran, Iran Tehran Iran
Phone: +98 2122415367
Fax: +98 2122418180
http://www.jmerc.ac.ir
What processes are involved for a request to access data/document
The request is submitted to the supervisor through JMERC. In case of initial agreement, the Reaserch Committee will make the final decision.