Protocol summary

Study aim
The effect of exercise on improving respiratory function and physical activity in hospitalized patients
Design
A randomized clinical trial with the control group, with a sample size of 40 and with parallel and single blind groups
Settings and conduct
Patients with COVID-19 admitted to Masih Daneshvari Hospital in Tehran are randomly divided into two groups. In the experimental group, at the time of discharge, in addition to the routine medication program, the standard physical exercise program is provided to the patients and the control group is given only the routine medication program. Indicators including quality of life, six-minute walk test, Borg scale and physical activity of patients at discharge, after a week and then a month later are evaluated in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include COVID-19 evidence, oxygen saturation less than 90%, and ability to exercise. Exclusion criteria included the patient's inability to exercise, acute neuromuscular disease, severe multiorgan failure, and refusal to attend.
Intervention groups
In the experimental group, patients receive an exercise program in addition to the medication plan upon discharge from the hospital. In the control group, patients receive only the necessary medication program upon discharge from the hospital. In both groups, quality of life, six-minute walking test distance, shortness of breath, oxygen saturation, and physical activity are assessed in three stages at discharge, after two weeks, and after one month.
Main outcome variables
Quality of life, distance traveled in the six-minute test, Dyspnea, physical activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160516027929N10
Registration date: 2021-05-03, 1400/02/13
Registration timing: registered_while_recruiting

Last update: 2021-05-03, 1400/02/13
Update count: 0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise training on improving respiratory function and physical activity in hospitalized patients COVID-19 referred to Masih Daneshvari Hospital
Public title
The effect of exercise on respiratory function of patients with Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of covid-19 by CTSCAN or PCR test Saturation below 90% Ability to do physical exercises
Exclusion criteria:
Inability to exercise Acute neuromuscular disease Personal dissatisfaction with participation in the study Severe multiorgan failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple randomization method with the help of a table of random numbers based on the code assigned to each patient are divided into two groups. Patients who have an individual code are in the control group and patients who have an even code are in the experimental group.
Blinding (investigator's opinion)
Double blinded
Blinding description
To avoid any possible complications, the primary caregiver is aware of how the groups are assigned. The researcher has also evaluated the consequences of assigning individuals to blind groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.SBMU.NRITLD.REC.1400.002

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.02
ICD-10 code description
COVID-19 disease

Primary outcomes

1

Description
Quality of Life
Timepoint
At discharge, after two weeks after one month
Method of measurement
SF12 Questionnaire

2

Description
The distance traveled in the test is six minutes
Timepoint
At discharge, after two weeks after one month
Method of measurement
The six-minute walk test

3

Description
Dyspnea
Timepoint
At discharge, after two weeks after one month
Method of measurement
Borg scale

4

Description
Physical activity
Timepoint
At discharge, after two weeks after one month
Method of measurement
Short physical performance battery questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group receive exercise program during discharge from the hospital in addition to the necessary medication program.
Category
Rehabilitation

2

Description
Control group: Patients in this group receive only the necessary medication program upon discharge from the hospital.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Atefeh Fakharian
Street address
Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
198396411
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
r. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
fakharian_2005@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhaneh Zahiri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biotechnology
Street address
Dr. Masih Daneshvari Hospital, Darabad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 5050
Email
zahirireyhane@gmail.com

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
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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