Investigating the impact of breathing exercise ( through virtual education )on the general health of patients infected with Covid-19 in shiraz . Randomized clinical trial
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General information
2020-12-21, 1399/10/01
2021-05-31, 1400/03/10
20202021-1205-2131 00:00:00
2021-01-19, 1399/10/30
2021-09-11, 1400/06/20
2021-0109-1911 00:00:00
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Due to the late acceptance of the proposal, the start date of the work and the patient were postponed, and since this study is a clinical coincidence, the start and end date of the work is edited.
Due to the late acceptance of the proposal, the start date of the work and the patient were postponed, and since this study is a clinical coincidence, the start and end date of the work is edited.
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به دلیل دیر اکسپت شدن پرپوزال ، تاریخ شروع کار و بیمار گیری به تعویق افتاده است، و از آن جایی که این مطالعه یک تصادفی بالینی هست، به همین دلیل تاریخ شروع و پایان کار ویرایش می شود.
به دلیل دیر اکسپت شدن پرپوزال ، تاریخ شروع کار و بیمار گیری به تعویق افتاده است، و از آن جایی که این مطالعه یک تصادفی بالینی هست، به همین دلیل تاریخ شروع و پایان کار ویرایش می شود.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Ghasemi
Full name of responsible person - Persian: دکتر قاسمی
Street address - English: Khalili Aveno, front of Maaref school
Street address - Persian: خیابان خلیلی، روبه روی آموزشگاه معارف
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814336
Phone: +98 71 3628 1506
Fax:
Email: Info@sums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Younes Ghasemi
Full name of responsible person - Persian: دکتر یونس قاسمی
Street address - English: Khalili Aveno, front of Maaref school
Street address - Persian: خیابان خلیلی، روبه روی آموزشگاه معارف
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134814336
Phone: +98 71 3628 1506
Fax:
Email: Info@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr Younes Ghasemi Full name of responsible person - Persian: دکتر یونس قاسمی Street address - English: Khalili Aveno, front of Maaref school Street address - Persian: خیابان خلیلی، روبه روی آموزشگاه معارف City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134814336 Phone: +98 71 3628 1506 Fax: Email: Info@sums.ac.ir Web page address:
Protocol summary
Study aim
Improving general health in patients infected with Covid-19, by using virtual education of breathing exercises.
Design
Clinical trial with control group, with parallel group, double-blind, randomized, phase 3 on 70 patients. Blocked random method is used for randomization.
Settings and conduct
Patients in the treatment group learn respiratory exercises through virtual training and are regularly monitored during the 4 weeks of study; While the control group only receives sports training in the form of pamphlets and basic explanations. Patients in both groups complete the general health questionnaire before and after the study and the results are compared. Questionnaire questioner and statistical analyzer are blind in this study
Participants/Inclusion and exclusion criteria
The inclusion criteria: 1) being diagnosed with COVID through PCR test or typical pattern through X-ray or CT Scan 2) a mild form of this virus which enables patients to look after themselves at home and they do not need to be hospitalized 3)having clinical stability 4)being able to understand and do breathing exercises online 5)being in the 18 to 65 age groups.
The exclusion criteria : 1) having other lung diseases such as COPD and asthma 2) having advanced background heart diseases 3) having background uncontrolled diseases 4) being infected and hospitalized due to COVID 5) having background lower and upper motor neuron diseases 6) lack of awareness of and access to virtual world 7) refusing consent for participating in this study
Intervention groups
Patients in the treatment group learn breathing exercises through virtual training and are monitored regularly throughout the 4 weeks of study; While the control group only receives sports training in the form of pamphlets and basic explanations.
Main outcome variables
Improving public health and reduction of anxiety and depression in patients with Corona Virus
General information
Reason for update
Due to the late acceptance of the proposal, the start date of the work and the patient were postponed, and since this study is a clinical coincidence, the start and end date of the work is edited.
Acronym
IRCT registration information
IRCT registration number:IRCT20201204049600N1
Registration date:2021-04-06, 1400/01/17
Registration timing:prospective
Last update:2021-04-27, 1400/02/07
Update count:1
Registration date
2021-04-06, 1400/01/17
Registrant information
Name
Sheida Shojaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4224 1345
Email address
drsheidashojaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of breathing exercise ( through virtual education )on the general health of patients infected with Covid-19 in shiraz . Randomized clinical trial
Public title
Investigating the impact of breathing exercises on general health of patient infected with Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being diagnosed with COVID-19 through PCR test.
Pulmonary involvement with typical pattern through Chest X-ray or Chest CT Scan.
A mild form of disease which enables patients to look after themselves at home and they do not need to be hospitalized.
Having clinical stability.
Being able to understand and do breathing exercises online.
Being in the 18 to 65 age groups.
Exclusion criteria:
Presence and history of other lung diseases such as COPD and asthma...
History of advanced heart disease such as IHD and CHF...
History of uncontrolled diseases including liver, kidney and thyroid and...
History of hospitalization in ICU due to Corona VIRUS.
History of lower motor neuron diseases including motor neuron diseases, peripheral neuropathy, neuromuscular junction disease and myopathy
History of upper motor neuron diseases such as stroke and M.S and... .
Lack of access and awareness of cyberspace.
Dissatisfaction with participating in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical intervention study, patients in both groups are the same and are randomly assigned; Thus, random allocation of patients is done using block randomization with two permutations AB and BA. In this way, 35 numbers are randomly selected from the table of random numbers, and if the numbers are between zero and 4, block AB is assigned to them, and if they are 5-9, block BA is assigned to them, and thus two lists of 35 people include two We will have an intervention and control group at random. For concealment, this method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by this person who is unaware of the division of groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant: In this study, we are not able to blind the patient, because patients of both interventions are aware of the type of intervention.
Clinical caregiver: We teach the person in charge of patient care and follow-up how to complete the questionnaire. This person has no knowledge of the type of patient intervention.
Researcher: In this study, we do not have the ability to blind the researcher, because the research does both studies himself and is aware of the type of intervention in each group.
Outcome Assessor: Completed questionnaires are given to a person who is not aware of the interventions performed and he / she is asked to determine the amount of stress, anxiety and depression reduction and increase general health in each person according to the questionnaire.
Data Analyzer: The questionnaires are finally given to a person to review the information after completing and collecting all the information. This person does not know any of the steps of the work and how to divide the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Doostan apartment, Alley 24th, Narvan street, Eram blvd., shiraz
City
Shiraz
Province
Fars
Postal code
71447-54388
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.SUMS.MED.REC.1399.433
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduce general health of patient infected with Covid-19
Timepoint
The beginning and the end of the study.
Method of measurement
General health qustionnair (GHQ)
Secondary outcomes
1
Description
Function of patient
Timepoint
The beginning and the end of the study.
Method of measurement
Medical Research Council Breathlessness Scale (MRC dyspnea scale)
Intervention groups
1
Description
Intervention group: This group learns breathing exercises completely for a month through cyberspace (WhatsApp and Instagram). Then we will contact them regularly (two to three times a week) and answer their questions. Patients fill in the questionnaires at the beginning and end of the study. Patients exercise for one month and six days a week, three times a day and five times a day.
Category
Rehabilitation
2
Description
Intervention group: This group only receives educational pamphlets and basic trainings at the beginning of the month. But they are asked to do exercises 6 times a week, 3 times a day, 5 times a day. The difference is that we do not have much contact with patients during a month and only at the beginning and end of the study, the questionnaires are filled out by patients.
Hazrat Ali Asghar Educational and Medical Center, in front of Homa Hotel, Meshkinfam street, Shiraz.
City
Shirazi
Province
Fars
Postal code
۷۱۴۳۹-۱۸۷۹۶
Phone
+98 71 3228 8602
Email
aliasghar@sums.ac.ir
4
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Seyyed Mohammad Kazem Tadayon
Street address
Shahid Faghihi Hospital, Next to the Medical School, Zand blvd,Shiraz.
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۴۱۱۹
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
Khalili Aveno, front of Maaref school
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
Info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sheida Shojaei
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Doostan apartment, Alley 24th, Narvan street, Eram blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
71447-54388
Phone
+98 71 4224 1345
Email
Drsheidashojaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sheida Shojaei
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Doostan apartment, Next to the Bakery,24th Narvan Alley,Narvan street, Eram blvd, Shiraz.
City
Shirazi
Province
Fars
Postal code
۷۱۴۴۷-۵۴۳۸۸
Phone
+98 71 4224 1345
Email
Drsheidashojaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sheida Shojaei
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Doostan apartment, Alley 24th, Narvan street, Eram blvd
City
Shiraz
Province
Fars
Postal code
71447-54388
Phone
+98 71 4224 1345
Email
Drsheidashojaei@gmail.com
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
Yes - There is 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
Yes - There is 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
All available data can be shared after making people unidentifiable
When the data will become available and for how long
Access period starts 1year after the results are published.
To whom data/document is available
everyone can access to this information
Under which criteria data/document could be used
If the information in this study helps to improve the science process
From where data/document is obtainable
Drsheidashojaei@gmail.com 00989214783046
What processes are involved for a request to access data/document
After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.