To assess the effect of aerobic exercise on cardiorespiratory indexes after discharge in patients improved from Covid-19
Design
This is a randomized clinical trial, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with Covid-19 referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Discharge after affected with Covid-19;
Exclusion criteria:
Cardiopulmonary diseases;
Any physical disorder
Intervention groups
Intervention group:
Post discharge care plus aerobic exercise at home (including stretching movements; sit-ups; push-up; roping) 40 minutes daily for 6 weeks
Control group:
Just routine post discharge care
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic exercise on cardiorespiratory indexes after discharge in patients improved from Covid-19: a randomized clinical trial
Public title
Effect of aerobic exercise on cardiorespiratory indexes after discharge in patients improved from Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years;
Discharge after affected with Covid-19;
Exclusion criteria:
Cardiopulmonary diseases
Any physical disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots with replacement through simple randomization. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.UMSHA.REC.1400.243
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Pulse rate
Timepoint
Before intervention and 6 weeks after that
Method of measurement
Using MWT6 device (manufactured by COSMED Co., Italy)
2
Description
Severity of dyspnea
Timepoint
Before intervention and 6 weeks after that
Method of measurement
Using MWT6 device (manufactured by COSMED Co., Italy)
3
Description
Arterial blood oxygen saturation
Timepoint
Before intervention and 6 weeks after that
Method of measurement
Using MWT6 device (manufactured by COSMED Co., Italy)
4
Description
Fatigue rate
Timepoint
Before intervention and 6 weeks after that
Method of measurement
Using Borg index (Borg scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Post discharge care plus aerobic exercise at home (including stretching movements; sit-ups; push-up; roping) 40 minutes daily for 6 weeks
Category
Treatment - Other
2
Description
Control group: Just routine post discharge care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Fahimeh Einabadi
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fahimeeinabadii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fahimeh Einabadi
Position
Student of Physiology of Health
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fahimeeinabadii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Nadi
Position
Internist
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nadi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available