Evaluating the effect of beetroot extract supplementation coinciding with resistance training on maximum concentric peak torque and power of the quadriceps and hamstring muscles in semi-professional male athletes after anterior cruciate ligament surgery
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Protocol summary
Determining the effect of 4 weeks of beetroot extract supplement along with resistance training on body composition, maximum concentric torque, and power in quadriceps and hamstring muscles at 60, 120 and 300 degrees per second after ACL surgery
Determining the effect of 4 weeks of beetroot extract supplement along with resistance training on body composition, maximum concentric torque, and power in quadriceps and hamstring muscles at 60, 90 and 120 degrees per second after ACL surgery
Determining the effect of 4 weeks of beetroot extract supplement along with resistance training on body composition, maximum concentric torque, and power in quadriceps and hamstring muscles at 60, 12090 and 300120 degrees per second after ACL surgery
تعیین تأثیر 4 هفته مصرف مکمل عصاره چغندر قرمز همراه با تمرین مقاومتی بر ترکیب بدنی، حداکثر گشتاور کانستریکی و توان عضلات چهارسر و همسترینگ با سه سرعت زاویه 60،120 و300 درجه بر ثانیه بعد از جراحی ACL
تعیین تأثیر 4 هفته مصرف مکمل عصاره چغندر قرمز همراه با تمرین مقاومتی بر ترکیب بدنی، حداکثر گشتاور کانستریکی و توان عضلات چهارسر و همسترینگ با سه سرعت زاویه 60، 90 و 120 درجه بر ثانیه بعد از جراحی ACL
تعیین تأثیر 4 هفته مصرف مکمل عصاره چغندر قرمز همراه با تمرین مقاومتی بر ترکیب بدنی، حداکثر گشتاور کانستریکی و توان عضلات چهارسر و همسترینگ با سه سرعت زاویه 60، 90 و 120 و300 درجه بر ثانیه بعد از جراحی ACL
Single arm, non-randomized, unblinded, phase 2 clinical trial on 23 male athletes
Non-randomized, parallel, unblinded, phase 2 clinical trial on 46 male athletes
Single armNon-randomized, non-randomizedparallel, unblinded, phase 2 clinical trial on 2346 male athletes
کارآزمایی بالینی تک گروهه ،غیرتصادفی ،بدون کورسازی ، فاز 2 بر روی 23 مرد ورزشکار
کارآزمایی بالینی موازی،غیرتصادفی ،بدون کورسازی ، فاز 2 بر روی 46 مرد ورزشکار
کارآزمایی بالینی تک گروهه موازی،غیرتصادفی ،بدون کورسازی ، فاز 2 بر روی 2346 مرد ورزشکار
This study will be conducted in the filed of post ACL reconstruction surgery rehabilitation on 23 male athletes (18 to 35 years old) who underwent ACL reconstruction surgery 90 days prior to the study in a sports medicine center in Mashhad.
All subjects will follow a similar exercise protocol of 90-minute strength training 3 sessions per week for 4 weeks (overall 12 sessions).
Subjects will consume 250 ml beetroot extract containing 40% of ADI for nitrate based on their body weight, two hours before exercise in 2 non-consecutive sessions. Besides performing similar strength exercises, a nitrated restricted diet will be prescribed to the subjects.
Maximum concentric torque and quadriceps and hamstring power by isokinetic device and lean body mass by body composition analyzer will be assessed at baseline and 48 hours after the last exercise session.
This study will be conducted in the filed of post ACL reconstruction surgery rehabilitation on 46 male athletes (18 to 35 years old) who underwent ACL reconstruction surgery (after 90 days) in a sports medicine center in Mashhad.
All subjects (intervention and control groups) will follow a similar exercise protocol of 90-minute strength training 3 sessions per week for 4 weeks (overall 12 sessions).
The intervention group will also consume 250 ml beetroot extract (40% ADI for nitrate), two hours before exercise in 2 non-consecutive sessions. A list of nitrate rich foods will be given to subjects to reduce dietary nitrate intake.
Maximum concentric torque and quadriceps and hamstring power by isokinetic device and body composition by body composition analyzer will be assessed at baseline and 48 hours after the last exercise session.
This study will be conducted in the filed of post ACL reconstruction surgery rehabilitation on 2346 male athletes (18 to 35 years old) who underwent ACL reconstruction surgery (after 90 days prior to the study) in a sports medicine center in Mashhad. All subjects (intervention and control groups) will follow a similar exercise protocol of 90-minute strength training 3 sessions per week for 4 weeks (overall 12 sessions). SubjectsThe intervention group will also consume 250 ml beetroot extract containing (40% of ADI for nitrate based on their body weight), two hours before exercise in 2 non-consecutive sessions. Besides performing similar strength exercises, a nitrated restricted dietA list of nitrate rich foods will be prescribedgiven to the subjects to reduce dietary nitrate intake. Maximum concentric torque and quadriceps and hamstring power by isokinetic device and lean body masscomposition by body composition analyzer will be assessed at baseline and 48 hours after the last exercise session.
این مطالعه در زمینه بازتوانی بعد از عمل ACL در 23 مرد ورزشکار (18 تا 35 ساله) که تحت عمل بازسازی ACL قرار گرفته باشند و 90 روز از عمل آنها گذشته باشددر یک مرکز پزشکی ورزشی در مشهد انجام خواهد گرفت.
تمامی آزمودنیها یک پروتکل تمرین مقاومتی یکسان شامل 3 جلسه در هفته تمرین مقاومتی را به مدت 4 هفته (در مجموع 12 جلسه) و با مدت زمان 90 دقیقه تمرین در هر جلسه اجراخواهند کرد.
آزمودنیها در 2 جلسه غیر متوالی در هفته، 2 ساعت قبل از شروع تمرین میزان250 میلی لیتر عصاره چغندر حاوی 40% ADI نیترات بر حسب وزن فرد دریافت خواهند کرد. علاوه بر انجام تمرین مقاومتی یکسان، جهت کنترل عوامل مداخله گر محقق یک برنامه غذایی با نیترات رژیمی محدود ارائه خواهد داد.
اندازه گیری حداکتر گشتاور کانستریکی و توان عضلات چهارسر و همسترینگ با استفاده از دستگاه ایزوکینتیک و توده بدون چربی با استفاده از دستگاه بادی کامپوزیشن در ابتدای مطالعه و 48 ساعت بعد از آخرین جلسه تمرینی اندازه گیری خواهد شد.
این مطالعه در زمینه بازتوانی بعد از عمل ACL در 46 مرد ورزشکار (18 تا 35 ساله) که تحت عمل بازسازی ACL (بعد از 90 روز) قرار گرفته باشند در یک مرکز پزشکی ورزشی در مشهد انجام خواهد گرفت.
تمامی آزمودنیها (گروه های مداخله و کنترل) یک پروتکل تمرین مقاومتی یکسان شامل 3 جلسه در هفته تمرین مقاومتی را به مدت 4 هفته (در مجموع 12 جلسه) و با مدت زمان 90 دقیقه تمرین در هر جلسه اجراخواهند کرد.
گروه مداخله در 2 جلسه غیر متوالی در هفته، 2 ساعت قبل از شروع تمرین میزان250 میلی لیتر عصاره چغندر (40% ADI نیترات) نیز دریافت خواهند کرد. جهت محدود سازی دریافت نیترات غذایی، لیست غذاهای حاوی نیترات بالا به آزمودنی ها داده خواهد شد.
اندازه گیری حداکتر گشتاور کانستریکی و توان عضلات چهارسر و همسترینگ با استفاده از دستگاه ایزوکینتیک و ترکیب بدن با استفاده از دستگاه بادی کامپوزیشن در ابتدای مطالعه و 48 ساعت بعد از آخرین جلسه تمرینی اندازه گیری خواهد شد.
این مطالعه در زمینه بازتوانی بعد از عمل ACL در 2346 مرد ورزشکار (18 تا 35 ساله) که تحت عمل بازسازی ACL (بعد از 90 روز) قرار گرفته باشند و 90 روز از عمل آنها گذشته باشددردر یک مرکز پزشکی ورزشی در مشهد انجام خواهد گرفت. تمامی آزمودنیها (گروه های مداخله و کنترل) یک پروتکل تمرین مقاومتی یکسان شامل 3 جلسه در هفته تمرین مقاومتی را به مدت 4 هفته (در مجموع 12 جلسه) و با مدت زمان 90 دقیقه تمرین در هر جلسه اجراخواهند کرد. آزمودنیهاگروه مداخله در 2 جلسه غیر متوالی در هفته، 2 ساعت قبل از شروع تمرین میزان250 میلی لیتر عصاره چغندر حاوی (40% ADI نیترات بر حسب وزن فرد) نیز دریافت خواهند کرد. علاوه بر انجام تمرین مقاومتی یکسان، جهت کنترل عوامل مداخله گر محقق یک برنامه غذایی بامحدود سازی دریافت نیترات رژیمی محدود ارائهغذایی، لیست غذاهای حاوی نیترات بالا به آزمودنی ها داده خواهد دادشد. اندازه گیری حداکتر گشتاور کانستریکی و توان عضلات چهارسر و همسترینگ با استفاده از دستگاه ایزوکینتیک و توده بدون چربیترکیب بدن با استفاده از دستگاه بادی کامپوزیشن در ابتدای مطالعه و 48 ساعت بعد از آخرین جلسه تمرینی اندازه گیری خواهد شد.
Inclusion criteria: Male athletes who have undergone ACL reconstruction surgery using the allograft technique 90 days prior to inclusion in the study.
No entry conditions: Allergy to beetroot, bilateral injuries to the knee and other tissues and ligaments of the knee, including intra-articular fractures, consuming beetroot extract less than 2 times a week during the study, failure to follow the diet and exercise program based on research protocol
Inclusion criteria: Male athletes who have undergone ACL reconstruction (allograft technique) 90 days prior to inclusion in the study.
No entry conditions: Allergy to beetroot, bilateral injuries to the knee and other tissues and ligaments of the knee, including intra-articular fractures, consuming beetroot extract less than 2 times a week during the study, failure to follow the diet and exercise program based on research protocol
Inclusion criteria: Male athletes who have undergone ACL reconstruction surgery using the (allograft technique) 90 days prior to inclusion in the study. No entry conditions: Allergy to beetroot, bilateral injuries to the knee and other tissues and ligaments of the knee, including intra-articular fractures, consuming beetroot extract less than 2 times a week during the study, failure to follow the diet and exercise program based on research protocol
شرایط ورود: ورزشکاران مرد که تحت عمل جراحی ACL با استفاده از تکنیک آلوگرفت قرارگرفته و مدت 90 روز از عمل آنها گذشته باشد.
شرایط عدم ورود : آلرژی به چغندر قرمز، آسیب های دو طرفه زانو و سایر بافت ها ولیگامان های زانو از جمله شکستگی درون مفصلی، مصرف کمتر از 2 بار در هفته از عصاره چغندر در طول پژوهش، عدم رعایت رژیم غذایی و برنامه تمرینی بر اساس پروتکل مطالعه
شرایط ورود: ورزشکاران مرد که تحت عمل جراحی ACL (تکنیک آلوگرفت قرارگرفته) و مدت 90 روز از عمل آنها گذشته باشد.
شرایط عدم ورود : آلرژی به چغندر قرمز، آسیب های دو طرفه زانو و سایر بافت ها ولیگامان های زانو از جمله شکستگی درون مفصلی، مصرف کمتر از 2 بار در هفته از عصاره چغندر در طول پژوهش، عدم رعایت رژیم غذایی و برنامه تمرینی بر اساس پروتکل مطالعه
شرایط ورود: ورزشکاران مرد که تحت عمل جراحی ACL با استفاده از (تکنیک آلوگرفت قرارگرفته) و مدت 90 روز از عمل آنها گذشته باشد. شرایط عدم ورود : آلرژی به چغندر قرمز، آسیب های دو طرفه زانو و سایر بافت ها ولیگامان های زانو از جمله شکستگی درون مفصلی، مصرف کمتر از 2 بار در هفته از عصاره چغندر در طول پژوهش، عدم رعایت رژیم غذایی و برنامه تمرینی بر اساس پروتکل مطالعه
250 cc beetroot extract containing 40% ADI of nitrate per body weight
There is no control group
Intervention group: 250 cc beetroot extract (40% ADI of nitrate) with resistance exercise
Control group: Resistance exercise
Intervention group: 250 cc beetroot extract containing (40% ADI of nitrate per body weight There is no control) with resistance exercise Control group: Resistance exercise
250 سی سی عصاره چغندر قرمز حاوی 40% ADI نیترات بر حسب وزن فرد
گروه کنترل ندارد
گروه مداخله: 250 سی سی عصاره چغندر قرمز (40% ADI نیترات) به همراه تمرینات مقاومتی
گروه کنترل: تمرینات مقاومتی
گروه مداخله: 250 سی سی عصاره چغندر قرمز حاوی (40% ADI نیترات بر حسب وزن فرد) به همراه تمرینات مقاومتی گروه کنترل ندارد: تمرینات مقاومتی
General information
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46
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Failure to update previous revision
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عدم اعمال تغییرات در نسخه قبل
عدم اعمال تغییرات در نسخه قبل
This study is a single arm non-randomized trial
This study is a non-randomized parallel clinical trial with control group
This study is a single arm non-randomized parallel clinical trial with control group
این مطالعه کارآزمایی تک گروهه غیر تصادفی است
این مطالعه کارآزمایی بالینی موازی غیر تصادفی با گروه کنترل است
این مطالعه کارآزمایی تک گروههبالینی موازی غیر تصادفی با گروه کنترل است
Protocol summary
Study aim
Determining the effect of 4 weeks of beetroot extract supplement along with resistance training on body composition, maximum concentric torque, and power in quadriceps and hamstring muscles at 60, 90 and 120 degrees per second after ACL surgery
Design
Non-randomized, parallel, unblinded, phase 2 clinical trial on 46 male athletes
Settings and conduct
This study will be conducted in the filed of post ACL reconstruction surgery rehabilitation on 46 male athletes (18 to 35 years old) who underwent ACL reconstruction surgery (after 90 days) in a sports medicine center in Mashhad.
All subjects (intervention and control groups) will follow a similar exercise protocol of 90-minute strength training 3 sessions per week for 4 weeks (overall 12 sessions).
The intervention group will also consume 250 ml beetroot extract (40% ADI for nitrate), two hours before exercise in 2 non-consecutive sessions. A list of nitrate rich foods will be given to subjects to reduce dietary nitrate intake.
Maximum concentric torque and quadriceps and hamstring power by isokinetic device and body composition by body composition analyzer will be assessed at baseline and 48 hours after the last exercise session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male athletes who have undergone ACL reconstruction (allograft technique) 90 days prior to inclusion in the study.
No entry conditions: Allergy to beetroot, bilateral injuries to the knee and other tissues and ligaments of the knee, including intra-articular fractures, consuming beetroot extract less than 2 times a week during the study, failure to follow the diet and exercise program based on research protocol
Intervention groups
Intervention group: 250 cc beetroot extract (40% ADI of nitrate) with resistance exercise
Control group: Resistance exercise
Main outcome variables
Strength and power of quadriceps and hamstrings, body composition
General information
Reason for update
Failure to update previous revision
Acronym
IRCT registration information
IRCT registration number:IRCT20210217050393N2
Registration date:2021-07-26, 1400/05/04
Registration timing:registered_while_recruiting
Last update:2022-10-21, 1401/07/29
Update count:2
Registration date
2021-07-26, 1400/05/04
Registrant information
Name
REZA REZVANI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2418
Email address
rezvanir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of beetroot extract supplementation coinciding with resistance training on maximum concentric peak torque and power of the quadriceps and hamstring muscles in semi-professional male athletes after anterior cruciate ligament surgery
Public title
Evaluating the effect of beetroot extract supplementation coinciding with resistance training in rehabilitation of athletes with anterior cruciate ligament rupture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male semi-professional athletes who play in provincial teams in the fields of football, futsal, volleyball and basketball
Undergoing ACL reconstructing surgery using allograft technique
90 days have passed since the ACL reconstruction surgery
Adhere to the same protocol, which includes 40 sessions of physiotherapy with 60 sessions of exercise therapy, from the day of surgery to the end of 90 days for all subjects
Willingness to participate in research
Age between 18 and 35 years old
Exclusion criteria:
Disease including: diabetes, kidney stones, gallstones, cancer and other serious diseases
Taking any medication or performing extra exercise compared to the research protocol
Using oral and injectable nutritional supplements before and after the research period
Consumption of any herbal medicine
Allergy to beetroot
Smoking
Alcohol consumption
History of performing any surgery on the operated limb
Bilateral knee injuries
Damage to other tissues and ligaments of the knee, including intra-articular fractures
Age
From 18 years old to 35 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is a non-randomized parallel clinical trial with control group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of medical sciences
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.109
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament rehabilitation
ICD-10 code
M62.50
ICD-10 code description
Muscle wasting and atrophy, not elsewhere classified, unspecified site
Primary outcomes
1
Description
Maximum concentric torque of quadriceps and hamstring at 60 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 60 degree per second
2
Description
Maximum concentric torque of quadriceps and hamstring at 90 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 90 degree per second
3
Description
Maximum concentric torque of quadriceps and hamstring at120 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 120 degree per second
4
Description
Power of quadriceps and hamstring muscles at 60 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 60 degree per second
5
Description
Power of quadriceps and hamstring muscles at 90 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 90 degree per second
6
Description
Power of quadriceps and hamstring muscles at 120 degree per second
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Isokinetic device at 120 degree per second
Secondary outcomes
1
Description
body composition
Timepoint
Baseline and 48 hours after the last exercise session (4 weeks)
Method of measurement
Body analyzer device
Intervention groups
1
Description
Intervention group: 250 cc beetroot extract containing 40% ADI nitrate based on body weight will be given to the athlete two hours before exercise in two non-consecutive sessions. The duration of the intervention will be 4 weeks, which includes 12 sessions of resistance training and 8 servings of beetroot supplement. Sachets containing extract powder will be prepared by the Mashhad School of Pharmacy
Category
Rehabilitation
2
Description
Control group: Resistance training for 4 weeks including 12 resistance training sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehregan Pars Physiotherapy Center
Full name of responsible person
Mohammad Hossein Khabaz Kababi
Street address
Mehregan Pars building, Next to the Shahid Aghdaei 1St, Vakilabad 35 Ave, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188957202
Phone
+98 51 3869 3007
Email
ahoseleh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad university of medical sciences, Azadi squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code: 9177948564
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2418
Fax
Email
rezvanir@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code: 9177948564
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2418
Fax
Email
rezvanir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Rezvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code: 9177948564
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Phone
+98 51 3800 2418
Fax
Email
rezvanir@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD