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Effects of Eight-Week Resistance Training on the Quality of Life and Sleep Quality of Untrained Men with a History of COVID-19

Protocol summary

Study aim
This study aimed to analyze the effects of resistance training on the QOL and sleep quality in untrained men with a history of COVID-19. Based on inclusion and exclusion criteria, purposive sampling was employed to select 34 individuals who were willing to participate in the study. They were then randomly assigned to a resistance training group and a control group. In order to evaluate the pretest scores of sleep quality and those of QOL, the participants were asked to complete the PSQI and the SF-36, respectively. Subsequently, the training group received eight weeks of resistance training held three sessions weekly. The participants re-completed the foregoing questionnaires when all training sessions were over to determine their posttest scores.
Design
A clinical trial with a control group with parallel groups, 32 participants. The website www.graphpad.com was used for randomization.
Settings and conduct
Place of research: University of Tehran
Participants/Inclusion and exclusion criteria
The inclusion criteria: being male, being aged 18–30 years old, having a BMI of 18-30, having no experience of resistance training within the past six months, contracting the COVID-19 twelve weeks before the intervention or earlier, being diagnosed as a mild to moderate case of the COVID-19, and obtaining a total score of five or higher on the PSQI. The exclusion criteria: having a resting heart rate of above 100 beats per minute, having a blood pressure of below 90.60 mmHg, having a blood pressure of above 140.90 mmHg, having a blood oxygen saturation level of below 95%, taking sleep affecting drugs, smoking.
Intervention groups
Resistance Training Group: 8 weeks of resistance training, 3 times a week, 1 hour per session. Control group: not participate in any exercise program during the intervention period.
Main outcome variables
Quality of life ؛ Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230221057480N1
Registration date: 2023-03-04, 1401/12/13
Registration timing: retrospective

Last update: 2023-03-04, 1401/12/13
Update count: 0
Registration date
2023-03-04, 1401/12/13
Registrant information
Name
Morteza Bagheri Kalayeh
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1738
Email address
morteza.bagheri@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-05-26, 1401/03/05
Actual recruitment start date
2022-05-10, 1401/02/20
Actual recruitment end date
2022-05-26, 1401/03/05
Trial completion date
2022-07-27, 1401/05/05
Scientific title
Effects of Eight-Week Resistance Training on the Quality of Life and Sleep Quality of Untrained Men with a History of COVID-19
Public title
Effects of Eight-Week Resistance Training on the Quality of Life and Sleep Quality of Untrained Men with a History of COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being male Being aged 18–30 years old Having a body mass index (BMI) of 18-30 Having no experience of resistance training within the past six months Contracting the COVID-19 twelve weeks before the intervention or earlier Being diagnosed as a mild to moderate case of the COVID-19 Obtaining a total score of five or higher on the Pittsburgh Sleep Quality Index (PSQI)
Exclusion criteria:
Having a resting heart rate of above 100 beats per minute Having a blood pressure of below 90.60 mmHg Having a blood pressure of above 140.90 mmHg Having a blood oxygen saturation level of below 95% Taking sleep affecting drugs Smoking
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: 34
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
According to the inclusion and exclusion criteria, 34 men with an age range of 18 to 30 years and a body mass index of 25 to 30 kg/m2 were randomly divided into two groups of 17 people, control and experimental. Based on sortation, odd and even numbers were selected for experimental and control groups, respectively. Randomization was done on the web at www.graphpad.com.
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 in Research, Faculty of Sport Sciences and Health, University of Tehran
Street address
Faculty of Sport Sciences and Health, between 15th and 16th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
1439565188
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.UT.SPORT.REC.1401.005

Health conditions studied

1

Description of health condition studied
Coronavirus disease
ICD-10 code
U09
ICD-10 code description
Post COVID-19 condition

Primary outcomes

1

Description
Sleep quality
Timepoint
Before and after the intervention (after 8 weeks)
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

2

Description
Quality of life
Timepoint
Before and after the intervention (after 8 weeks)
Method of measurement
Short Form 36 Health Survey Questionnaire (SF-36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Resistance training, three times weekly over the course of eight weeks, The National Academy of Sports Medicine (NASM) guidelines on strength training and bodybuilding were employed to design the exercises, the training load increased by 5–10% every week. In each training session, the participants performed 3 sets of 12, barbell shoulder press, barbell bicep curl, hack squat, lying barbell triceps extension, lat pull down machine, barbell bench press, leg extension machine, dumbbell shrugs, and forearm plank.
Category
Rehabilitation

2

Description
Control group: control group will be asked not to participate in any exercise program and keep to their regular diet during research and report any changes in their life like disease, serious stress
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sports Sciences and Health, University of Tehran
Full name of responsible person
Morteza Bagheri Kalayeh
Street address
Faculty of Sport Sciences and Health, between 15th and 16th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
3419565188
Phone
+98 21 8835 1738
Email
morteza.bagheri@ut.ac.ir
Web page address
https://sport.ut.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Abbas Ali Gaeini
Street address
Faculty of Sport Sciences and Health, between 15th and 16th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
6518834151
Phone
+98 21 8835 1738
Email
infosport@ut.ac.ir
Web page address
https://sport.ut.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Sports Sciences and Health, University of Tehran
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
The University of Tehran
Full name of responsible person
Morteza Bagheri Kalayeh
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences and Health, between 15th and 16th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
6518834151
Phone
+98 21 8835 1738
Fax
Email
morteza.bagheri@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Sports Sciences and Health, University of Tehran
Full name of responsible person
Abbas Ali Gaeini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences and Health, between 15th and 16th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
3415165188
Phone
+98 21 8835 1738
Email
aagaeini@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Morteza Bagheri Kalayeh
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Faculty of Sport Sciences and Health, between 15th and 16th St., North Kargar St
City
Tehran
Province
Tehran
Postal code
1439951154
Phone
+98 21 8835 1738
Fax
Email
morteza.bagheri@ut.ac.ir

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 further information
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
Not applicable
Data Dictionary
Not applicable
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