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The effect of resistance and aerobic training on growth hormones cortisol, insulin-like growth factor 1, and depression in women with relapsing-remitting multiple sclerosis.

Protocol summary

Study aim
Determining the effect of resistance training and aerobic training on growth hormone, insulin-like growth factor-1, cortisol, and depression levels in patients with MS
Design
The clinical trial has a control group and three experimental groups, with parallel groups, unblinded, and randomized (sealed envelopes). It is conducted on 40 patients with MS in Rasht. The sealed envelope method was used for randomization.
Settings and conduct
Forty participants were randomly assigned to three groups (three experimental, one control). All completed the BDI and blood tests for GH, cortisol, and IGF-1 (ELISA). The first group did resistance training, the second did aerobic exercises, and the control group had no training. Post-tests were conducted after the interventions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 25–50 years; diagnosis of RRMS; EDSS 0.5–5.5; BDI ≥14/20; DPEI 0–5; regular menstrual cycles; no use of antidepressants, cigarettes, or alcohol; no thyroid, renal, or cardiovascular disease; ≥2 months since last regular exercise. Exclusion Criteria: Disease relapse; pain or discomfort during exercise; insufficient balance for safe training; participation in physiotherapy, massage, or rehabilitation within the last 3 months; history of cardiovascular disease, epilepsy, or migraine.
Intervention groups
Control group: 10 eligible individuals who do not participate in any training and only take the tests. Intervention group 1: 10 individuals who participate in resistance training. Intervention group 2: 10 eligible individuals who participate in aerobic training. Intervention group 3: 10 individuals who participate in combined aerobic and resistance training.
Main outcome variables
Growth Hormone, Cortisol, Insulin-like Hormone 1, Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250507065634N13
Registration date: 2026-01-01, 1404/10/11
Registration timing: prospective

Last update: 2026-01-01, 1404/10/11
Update count: 0
Registration date
2026-01-01, 1404/10/11
Registrant information
Name
mahnaz shafaei fallah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 930 0704
Email address
articlelab.com@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-08, 1404/10/18
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistance and aerobic training on growth hormones cortisol, insulin-like growth factor 1, and depression in women with relapsing-remitting multiple sclerosis.
Public title
The effect of resistance and aerobic training on patients with multiple sclerosis.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 25 and 50 years Women with depression in the Beck Depression Inventory range of 21-63 (BDI) Having depressive disorder with a severity of 0–5 on the DPEI scale Having regular menstrual cycles Not using antidepressant medications Disease severity (EDSS) between 0.5 and 5.5 No history of thyroid, renal, cardiovascular, or vascular diseases Having at least a 2-month interval since the last exercise training Non-smoker No alcohol consumption Having a relapsing-remitting type of Multiple Sclerosis (MS)
Exclusion criteria:
Recurrence of the disease Feeling of pain Lack of necessary balance during the exercises Participation in physiotherapy, massage therapy and rehabilitation programs in the last three months History of cardiovascular diseases, epilepsy and migraines
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the sample (40 eligible volunteers), all individuals are numbered. For randomization, opaque, light-tight, and sealed envelopes are used. Before the study begins, 40 envelopes are prepared, inside of which are placed equal numbers of papers labeled “Aerobic Exercise Test Group,” “Resistance Exercise Test Group,” and “Control Group.” The order of the papers in the envelopes is randomized, and the envelopes are then sealed. Upon entering the study, each individual randomly selects an envelope and is assigned to the experimental or control group based on its contents. This process ensures that the assignment of individuals to groups is completely random and that there is no possibility of prediction or interference in the assignment by the researcher or participants.
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
Research Ethics Committee of the Sports Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2021-09-20, 1400/06/29
Ethics committee reference number
IR.SSRI.REC.1400.1109

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Depression
Timepoint
Before intervention and immediately after completion of the intervention
Method of measurement
Beck Depression Inventory (BDI)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 10 participants who meet the inclusion criteria will be randomly assigned to the study as the control group. They will complete a depression questionnaire. ELISA will measure growth hormone, cortisol, and insulin-like growth factor levels before and after the intervention. However, they will not participate in any exercise.
Category
Diagnosis

2

Description
First intervention group: 10 patients with multiple sclerosis referred to Besat Hospital in Rasht, who meet the inclusion criteria and are randomly assigned to participate in the study as the intervention group. They complete a depression questionnaire, and their growth hormone, cortisol, and insulin-like growth hormone levels are measured by ELISA and blood tests before starting the exercises. Then, they are placed in strength training sessions for 30-40 minutes for 24 sessions, 3 sessions per week, over 3 weeks. Before starting the sessions, 6 training sessions will be completed. The exercises are strength-based, and 5-10 minutes are dedicated to warming up (walking and stretching), 25-35 minutes to basic weight-bearing exercises, and 5 minutes to cool down (stretching). After completing the sessions, their growth hormone, cortisol, and insulin-like growth hormone levels are measured again by ELISA and blood tests after the exercises.
Category
Diagnosis

3

Description
Second intervention group: The second intervention group consists of 10 women with relapsing–remitting multiple sclerosis who are referred to Ba’ath Hospital in Rasht and meet the inclusion criteria. Participants are randomly assigned to this group. At baseline, participants complete the Beck Depression Inventory (BDI), and serum levels of growth hormone, cortisol, and insulin-like growth factor 1 are measured before the initiation of the intervention through blood sampling using the Enzyme-Linked Immunosorbent Assay (ELISA) method. Subsequently, participants undergo an aerobic exercise training program for 8 weeks, with two sessions per week, totaling 16 sessions. Before the main intervention, 6 instructional sessions are conducted to familiarize participants with the correct performance of the exercises. Each aerobic exercise session lasts 20 to 40 minutes and consists of three parts to 10 minutes of warm-up (including walking and stretching exercises),20 to 30 minutes of the main exercise (walking), and 5 minutes of cool-down (stretching exercises). Exercise intensity is individually prescribed and monitored during the sessions based on the Borg Rating of Perceived Exertion (RPE) scale. After completion of the exercise program, serum levels of growth hormone, cortisol, and insulin-like growth factor 1 are re-measured through blood sampling using the ELISA method.
Category
Diagnosis

4

Description
Intervention group: Third intervention group: 10 people with multiple sclerosis referred to Besat Hospital in Rasht, who meet the inclusion criteria and are randomly assigned to participate in the study as the intervention group. They complete a depression questionnaire and their growth hormone, cortisol, and insulin-like growth hormone levels are measured by ELISA and blood tests before starting the exercises. Then, they participate in combined aerobic and resistance training sessions at each person's home. The duration of the sessions is 28 sessions, 2 sessions per week. After completing the sessions, their growth hormone, cortisol, and insulin-like growth hormone levels are measured again by ELISA and blood tests after the exercises.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Specialized and Subspecialized Clinic
Full name of responsible person
Kourosh Fakhimi
Street address
Besat Specialized and Subspecialized Clinic, Enqelab St, next to Tavaf Alley, Rasht, Gilan, Iran
City
Rasht
Province
Guilan
Postal code
4136617865
Phone
+98 13 3326 1451
Email
int@guilan.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Guilan
Full name of responsible person
Ali Bani
Street address
University Complex of Guilan, Km 5 Tehran Road, Khalij-e Fars Expressway, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0274
Email
int@guilan.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 Guilan
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 Guilan
Full name of responsible person
Faeze Alipour
Position
Master of Physical Education
Latest degree
Bachelor
Other areas of specialty/work
Physical Education
Street address
Ahmadi Sabet, 10th Alley, Jomhouri Street, Lahijan, Gilan Province, Iran
City
Lahijan
Province
Guilan
Postal code
۴۴۱۹۸۸۵۱۳۶
Phone
+98 937 156 1655
Email
faezealipour2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Payam Saidie
Position
Assistant Professor, University of Guilan
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University Complex of Guilan, Km 5 Tehran Road, Khalij-e Fars Expressway, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 911 194 3804
Email
payam.saidie@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Faeze Alipour
Position
Master of Physical Education
Latest degree
Bachelor
Other areas of specialty/work
Physical Education
Street address
Ahmadi Sabet, 10th Alley, Jomhouri Street, Lahijan, Gilan Province, Iran
City
Rasht
Province
Guilan
Postal code
۴۴۱۹۸۸۵۱۳۶
Phone
+98 937 156 1655
Email
faezealipour2@gmail.com

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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.
When the data will become available and for how long
Data can be made available 4 months after the results are published and after personally identifiable information is removed.
To whom data/document is available
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.
Under which criteria data/document could be used
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.
From where data/document is obtainable
If you need data, please contact
What processes are involved for a request to access data/document
After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible.
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