The effect of aerobic activity on immune and inflammatory system indicators in recovered patients of COVID-19
Design
This research is a clinical trial, semi-experimental field type. Among the male patients recovered from COVID--19 , 24 people are voluntarily selected under the supervision of a doctor specializing in infectious diseases and based on the inclusion criteria. Volunteers are placed in two groups of aerobic exercise and control based on a simple random method and in the form of a lottery.
Settings and conduct
Place of study: Khorramshahr University of Marine Sciences and Techniques, study population: patients with COVID-19, blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male patients recovered from COVID-19; Maximum oxygen consumption at least 25; Ability to participate in the training program; No other diseases.
Non-inclusion criteria:
having sports activity during the last 6 months; taking medication
Intervention groups
Intervention group: Aerobic exercise group that implements the aerobic exercise protocol including 3 sessions per week for eight weeks with an intensity of 50 to 70% of the reserve heart rate.
Control group: who do not perform any regular physical activity during the training period.
Khorramshahr university of Marine Science and Technology
Country
Iran (Islamic Republic of)
Phone
+98 61 5353 3819
Email address
d.rezaimanesh@kmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aerobic exercise on immune and inflammatory indicators in patients improved from COVID-19
Public title
The effect of aerobic activity on recovered patients from COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients who recovered from COVID-19
VO2 max above 25 mL/Kg.min-1
Ability to participate in the training program
Exclusion criteria:
participation in sports within the past year
Taking medicines
Smoking and alcohol drinking
Suffering from other diseases
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
First, calls are made in Abadan and Khorramshahr cities. Then, among the volunteers who declare their readiness, 24 are selected based on the criteria for entering the research. Subjects are placed in two groups by simple random method. In the simple random method, lottery is used. In this way, each person is assigned a number. Then the folded sheets containing the number of each candidate are placed in a container. Based on the lottery, the above numbers will be placed in two aerobic training group (12 people) and the control group (12 people), respectively.
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 Abadan University of Medical Sciences
Street address
At the beginning of Simeteri-e-Zulfikari
City
Abadan
Province
Khouzestan
Postal code
631981115426
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
IR.ABADANUMS.REC.1401.067
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
IL-6 plasma levels
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
2
Description
IL-10 plasma levels
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
3
Description
C-Reactive Protein – CRP
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
4
Description
Leukocytes
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
5
Description
Lymphocytes
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
6
Description
Neutrophils
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
7
Description
Monocytes
Timepoint
One day before the training protocol and 48 hours after the last training session
Method of measurement
special kit
Secondary outcomes
1
Description
Maximum oxygen consumption
Timepoint
Before and after the intervention
Method of measurement
Rockport walking test
Intervention groups
1
Description
Intervention group: The intensity of training in the first four weeks is 50 to 60% of the maximum reserve heart rate, and from the fifth to the eighth week, 60 to 70% of the reserve heart rate is considered. The training time started from 15 minutes in the first week and 5 minutes are added to the training time every week until the fourth week. Due to the increase in training intensity, 20 minutes will be added to the training time in the fifth week and 5 minutes will be added to the training time every week until the end of the training period.
Category
Behavior
2
Description
Control group: they don't receive any exercise intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Abadan Taleghani Hospital
Full name of responsible person
Davar Rezaeimanesh
Street address
Ayatollah Taleghani Hospital; Station 12; In front of Azad University
City
Abadan
Province
Khouzestan
Postal code
6316953111
Phone
+98 61 5353 1988
Email
davarrezaee@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Marine Sciences and Technologies
Full name of responsible person
Davar Rezaeimanesh
Street address
Koi-e-Asatid Street
City
Khorramshahr
Province
Khouzestan
Postal code
6318911154
Phone
+98 61 5353 1938
Email
davarrezaee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Marine Sciences and Technologies
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
Khorramshahr Marine Science and Technology University
Full name of responsible person
Davar Rezaeimanesh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
Koi-e-Asatid Street
City
Khorramshahr
Province
Khouzestan
Postal code
64199-34619
Phone
+98 61 5353 1938
Email
davarrezaee@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Marine Sciences and Technologies
Full name of responsible person
Davar Rezaeimanesh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
Koi-e-Asatid Street
City
Khorramshahr
Province
Khouzestan
Postal code
64199-34619
Phone
+98 61 5353 1938
Email
davarrezaee@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Marine Sciences and Technologies
Full name of responsible person
Davar Rezaeimanesh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
Koi-e-Asatid Street
City
Khorramshahr
Province
Khouzestan
Postal code
64199-34619
Phone
+98 61 5353 1938
Email
davarrezaee@yahoo.com
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