Examining the effects of different exercise modalities in patients with Covid-19
Design
A randomized controlled trial with a control group, parallel groups, single-blind, phase 3, patients (n=900), randomization will be performed by random number generation, and group assignment will be placed in a sealed envelope, which will be opened by the study coordinator at the time of randomization.
Settings and conduct
Laboratory-confirmed COVID-19 patients, Tehran, single-blind, randomization will be performed by random number generation, and group assignment will be placed in a sealed envelope, which will be opened by the study coordinator at the time of randomization.
Participants/Inclusion and exclusion criteria
Laboratory-confirmed COVID-19 patients.
Inclusion criteria: Tendency and ability to participate in exercise protocols.
Exclusion criteria: Participants with a history of using cigarettes and alcohol in the last 6 months.
Intervention groups
Non-exercise group.
Aerobic exercise training group.
Resistance exercise training group.
Resistance-aerobic exercise training group.
Main outcome variables
Tissue biomarkers including blood, saliva, semen, and urine.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160605028270N3
Registration date:2021-09-01, 1400/06/10
Registration timing:prospective
Last update:2021-09-01, 1400/06/10
Update count:0
Registration date
2021-09-01, 1400/06/10
Registrant information
Name
Behzad Hajizadeh Maleki
Name of organization / entity
Department of Sports Medicine, Institute of Sports Sciences, Justus-Liebig-University
Country
Iran (Islamic Republic of)
Phone
+49 641 9925210
Email address
behzad.hajizadeh-maleki@sport.uni-giessen.de
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
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
Exercise training and COVID-19: a randomized controlled trial
Public title
Exercise training and COVID-19: a randomized controlled trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
laboratory-confirmed COVID-19 patients.
Tendency and ability to participate in exercise protocols.
Exclusion criteria:
Physically active subjects.
Participants with a history of using cigarettes and alcohol in the last 6 months.
Age
From 20 years old to 94 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
900
More than 1 sample in each individual
Number of samples in each individual:
6
Baseline, week 4, 8, 12, 16, and 1 month of detraining.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by random number generation, and group assignment will be placed in a sealed envelope, which will be opened by the study coordinator at the time of randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researchers will not know which treatment or intervention the participant is receiving until the trial is over.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Allameh Tabataba'i University
Street address
Vice Chancellor for Research, Central Building, Village Square, Olympic Village, Allameh Tabatabai University,
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.ATU.REC.1399.061
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 disease
Primary outcomes
1
Description
Tissue biomarkers including blood, saliva, semen, and urine.
Timepoint
Baseline, weeks 4, 8, 12, 16, and one month of detraining.
Method of measurement
White blood cells, neutrophils, and lymphocytes in blood, saliva, seminal fluid, and urine will be measured according to the standard laboratory techniques.
Secondary outcomes
1
Description
Body composition
Timepoint
Baseline, weeks 4, 8, 12, 16 and 1 month of detraining.
Method of measurement
By using Omron body composition analyzer.
Intervention groups
1
Description
Non-exercise group: will not participate in any exercise training protocol.
Category
Rehabilitation
2
Description
Intervention group: aerobic exercise training. Subjects in this group will participate in moderate-intensity aerobic exercise training protocol three times per week for 16 weeks.
Category
Rehabilitation
3
Description
Intervention group: Resistance exercise training. Subjects in this group will participate in moderate-intensity resistance exercise training protocol three times per week for 16 weeks.
Category
Rehabilitation
4
Description
Intervention group: aerobic-resistance exercise training. Subjects in this group will participate in moderate-intensity aerobic-resistance exercise training protocol three times per week for 16 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Tabataba'i University,
Full name of responsible person
Behzad Hajizadeh Maleki
Street address
Vice Chancellor for Research, Central Building, Village Square, Olympic Village, Allameh Tabatabai University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
behzad.hajizadeh-maleki@sport.uni-giessen.de
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Allameh Tabataba’i University
Full name of responsible person
Behzad Hajizadeh Maleki
Street address
Vice Chancellor for Research, Central Building, Village Square, Olympic Village, Allameh Tabataba’i University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
behzad.hajizadeh-maleki@sport.uni-giessen.de
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba’i University
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
Allameh Tabataba’i University
Full name of responsible person
Behzad Hajizadeh Maleki
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Exercise Physiology and Sports Therapy
Street address
Vice Chancellor for Research, Central Building, Village Square, Olympic Village, Allameh Tabataba’i University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
behzad.hajizadeh-maleki@sport.uni-giessen.de
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allameh Tabataba’i University
Full name of responsible person
Behzad Hajizadeh Maleki
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Exercise Physiology and Sports Therapy
Street address
Allameh Tabataba’i University
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
behzad.hajizadeh-maleki@sport.uni-giessen.de
Person responsible for updating data
Contact
Name of organization / entity
Allameh Tabataba’i University
Full name of responsible person
Behzad Hajizadeh Maleki
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Exercise Physiology and Sports Therapy
Street address
Vice Chancellor for Research, Central Building, Village Square, Olympic Village, Allameh Tabataba’i University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
behzad.hajizadeh-maleki@sport.uni-giessen.de
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