Protocol summary

Study aim
Comparison of combined foam roller and aerobic exercises versus foam roller exercises alone on cytokine and adipokine levels in sedentary elderly overweight men
Design
This trial had a control group, with parallel and unblinded groups, conducted using simple randomization on 31 healthy, sedentary, overweight elderly men. A table of random numbers was used for randomization.
Settings and conduct
The study was conducted in an indoor futsal hall in Kerman province, and the study population of this trial was sedentary elderly men between the ages of 60 and 70.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not engaging in regular physical activity throughout the week (at least three days per week for 30 minutes); Overweight older adults aged 60 to 70 years. Exclusion criteria: Presence of specific diseases such as ...(MS, cancer, Parkinson's); undergoing surgery in recent months
Intervention groups
Intervention Group 1; Foam Roller Group: In this group, the subjects performed only foam roller exercises for 3 months, which included upper body and lower body exercises. Intervention Group 2; Foam Roller-Aerobic Group: In this group, the subjects performed fast walking or slow jogging along with foam roller exercises for the lower body muscles for 3 months. Control Group: no type of exercise or intervention was conducted.
Main outcome variables
Irisin; interleukin-6; Adipolin; glycophorin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251029067810N1
Registration date: 2026-08-16, 1405/05/25
Registration timing: retrospective

Last update: 2026-08-16, 1405/05/25
Update count: 0
Registration date
2026-08-16, 1405/05/25
Registrant information
Name
Hamidreza Shakermahani
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 34 3261 0540
Email address
hamidreza.shaker@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-30, 1402/03/09
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
2023-07-31, 1402/05/09
Actual recruitment end date
2023-09-01, 1402/06/10
Trial completion date
2024-05-27, 1403/03/07
Scientific title
Comparison of combined foam roller and aerobic exercises versus foam roller exercises alone on cytokine and adipokine levels in sedentary elderly overweight men
Public title
The effects of combining foam roller exercises and aerobic exercises on cytokine and adipokine levels in sedentary overweight elderly men.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
They do not engage in regular physical activity throughout the week (at least three days per week for 30 minutes). Participants should not have a history of smoking or drinking alcoholic beverages. Participants should not have undergone any surgery in the three months prior to the start of the exercise protocol and should not have had any fractures in their limbs. Overweight older adults aged 60 to 70 years were enrolled in the study protocol.
Exclusion criteria:
Presence of specific diseases such as ...(MS, cancer, Parkinson's) History of smoking and alcohol consumption Undergoing specific surgery within 3 months prior to the start of the exercise protocol Presence of fractures in the limbs
Age
From 60 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 31
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Using Random Number Table Method. In this method, a table was prepared containing numbers 1 to 31 arranged completely randomly. Each of the 31 subjects was assigned a number. For the starting point and the first desired number, a number was selected randomly by chance. From the starting point, numbers were read row by row, and for each of the 3 groups, numbers were extracted and assigned to the intervention and control groups.
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 and Research Committee of the Faculty of Sports Sciences and Health, University of Tehran
Street address
Opposite the Daneshgah Alley, between 15th and 16th streets, above Jalal Al-Ahmad intersection, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1439813117
Approval date
2023-07-02, 1402/04/11
Ethics committee reference number
IR.UT.SPORT.REC.1402.043

Health conditions studied

1

Description of health condition studied
Overweight in the elderly.
ICD-10 code
E66.3
ICD-10 code description
Overweight

2

Description of health condition studied
physical inactivity in the elderly
ICD-10 code
Z72.3
ICD-10 code description
Lack of physical exercise

Primary outcomes

1

Description
Serum irisin level
Timepoint
Before the start of the intervention and after 3 months at the end of the exercises
Method of measurement
Through the ELISA test.

2

Description
Serum interleukin-6 level
Timepoint
Before the start of the intervention and after 3 months at the end of the exercises
Method of measurement
Through the ELISA test

3

Description
Serum adipolin level
Timepoint
Before the start of the intervention and after 3 months at the end of the exercises
Method of measurement
Through the ELISA test

4

Description
Serum glycophorin level
Timepoint
Before the start of the intervention and after 3 months at the end of the exercises
Method of measurement
Through the ELISA test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Foam Roller Group. The foam roller is a fitness tool used for myofascial release. In this study, 11 participants in the foam roller group performed foam roller exercises for 3 months, three days a week, at a specific time in a gym. The exercises in the foam roller group included upper and lower body workouts, which were conducted with a predetermined structure. The foam roller used in this intervention was manufactured in Taiwan.
Category
Other

2

Description
Intervention group 2: foam roller - aerobic.This group consisted of 11 subjects, and the subjects exercised in a gym three days a week at a specific time for 3 months. The aerobic protocol consisted of 40 minutes of brisk walking or jogging at 50 to 60 percent of maximum heart rate reserve. Foam roller exercises included only lower body exercises.
Category
Other

3

Description
Control group: without any intervention. From the control group, only blood samples, anthropometric measurements, and initial assessments were taken. Measurements and tests were performed once before the start of the training protocol and once 3 months later, after the completion of the intended exercises and interventions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Neshat’s Pathobiology Laboratory.
Full name of responsible person
Ali Neshat
Street address
Dr. Neshat’s Laboratory, 1st Floor, Atyeh Building, after Imam Jom’ah Crossroads, Jomhoori Eslami Boulevard.
City
Kerman
Province
Kerman
Postal code
6519541614
Phone
+98 34 3248 3220
Email
Dr_alineshat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of tehran
Full name of responsible person
Dr.Rahman Soori
Street address
In front of Tehran University Alley, between 15th Street and 16th Street, above the Jalal Al-Ahmad Intersection, North Kargar Street.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The 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
Hamidreza shakermahani
Position
researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Second house on the left, Lane 19, Hemmati-Far Street.
City
Kerman
Province
Kerman
Postal code
7618441317
Phone
+98 34 3261 0540
Email
hamidreza.shaker@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of tehran
Full name of responsible person
Hamidreza shakermahani
Position
researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Second house on the left, 19 Alley, Hemmatifar Street.
City
Kerman
Province
Kerman
Postal code
7618441317
Phone
+98 34 3261 0540
Email
hamidreza.shaker@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Hamidreza Shakermahani
Position
researcher
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Second house on the left, 19 Alley, Hemmatifar Street.
City
Kerman
Province
Kerman
Postal code
7618441317
Phone
+98 34 3261 0540
Email
hamidreza.shaker@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data can be shared Data related to the main factors of the article, which include Interleukin-6, Irisin, Adiponectin, and glycophorin.
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
Lecturers and researchers employed by universities
Under which criteria data/document could be used
Keeping the authors of the article informed
From where data/document is obtainable
Hamidreza shakermahani Hamidreza.shaker@ut.ac.ir 09211986959
What processes are involved for a request to access data/document
It will be sent after talking with the author within the appropriate timeframe
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