Protocol summary
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Study aim
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The aim of this study is to investigate the effect of elastic band resistance training on irisin, liver enzymes, hepatic steatosis and metabolic outcomes in obese postmenopausal women with MASLD
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Design
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Two-arm randomized controlled trial (Elastic band resistance training and control) with pre- and post-intervention assessments.
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Settings and conduct
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This study was conducted as a clinical trial involving 54 women aged 55-65 years.
Participants were randomly and evenly assigned to two groups: Elastic band resistance training group and the control group. The Elastic band resistance training group underwent 8 weeks of training, with three 60-minute sessions per week. Hepatic Steatosis, ALT, AST, GGT, Insulin, Glucose, Irisin were assessed before and after the intervention. No blinding was applied.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: hepatic steatosis, body mass index between 30 and 35 kg/m², stable body weight (±3%) during the preceding three months, and no engagement in structured exercise training within the previous six months. Exclusion criteria: alcohol consumption, diabetes mellitus, hormone therapy, use of medications known to affect hepatic fat content or insulin sensitivity within the prior six months, and any musculoskeletal, cardiovascular, or neurological condition contraindicating participation in resistance exercise.
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Intervention groups
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Elastic band resistance training group and the control group. Elastic band resistance training group completed a supervised elastic band resistance training program three times per week for eight consecutive weeks, yielding a total of 24 sessions, while the control group did not participate in any physical activity.
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Main outcome variables
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Hepatic Steatosis, ALT, AST, GGT, Insulin, Glucose, Irisin
General information
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Reason for update
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Dear IRCT Team,
First, we sincerely appreciate your valuable cooperation and for implementing the requested corrections in the clinical trial record.
Upon reviewing the updated record, we noticed that the Body Mass Index (BMI) and age criterion in the Abstract section has not yet been updated. This discrepancy was due to an administrative data entry error during the initial registration and does not reflect any change in the approved protocol, eligibility criteria, or study population.
We sincerely apologize for this oversight and kindly request, if possible, that the Abstract section also be updated to ensure full consistency between the registry record, the approved protocol, and the manuscript.
Thank you very much for your kind support and cooperation.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241205063953N4
Registration date:
2026-01-19, 1404/10/29
Registration timing:
prospective
Last update:
2026-07-19, 1405/04/28
Update count:
2
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Registration date
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2026-01-19, 1404/10/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-01-25, 1404/11/05
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Expected recruitment end date
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2026-03-25, 1405/01/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Elastic Band Resistance Training on irisin, liver enzymes, Hepatic Steatosis and Metabolic Outcomes in Postmenopausal Women with MASLD
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Public title
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Elastic Band Resistance Training and liver disease in Postmenopausal Women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Body mass index between 30 and 35 kg/m²
Stable body weight (±3%) during the preceding three months
No engagement in structured exercise training within the previous six months.
Exclusion criteria:
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Age
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From 55 years old to 65 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, simple randomization was used to assign participants to study groups. The randomization unit was individual, meaning that each person was independently assigned to one of the two groups: elastic band resistance training group (n = 27) or the control group (n = 27). The randomization tool was EXECL software which generated the random sequence before the study began to prevent allocation bias. Allocation concealment was ensured using sealed and numbered opaque envelopes containing the group assignment for each participant. These envelopes were opened only after a participant's eligibility was confirmed by an independent researcher not involved in the randomization process. Stratified randomization was applied based on age to ensure balance across groups for these key variables.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-08, 1398/11/19
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Ethics committee reference number
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IR.IAU.SHK.REC.1399.031
Health conditions studied
1
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Description of health condition studied
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Liver diseases
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ICD-10 code
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K75.81
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ICD-10 code description
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Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
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Description
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Hepatic Steatosis
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Timepoint
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48 hours before and after 8 weeks of research
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Method of measurement
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Method for quantifying liver fat content (CAP)
2
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Description
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ALT
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Timepoint
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48 hours before and after 8 weeks of research
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Method of measurement
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ALT levels were measured using a commercial kit (Pars Azmoon, Tehran, Iran) with enzymatic methods.
3
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Description
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AST
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Timepoint
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48 hours before and after 8 weeks of research
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Method of measurement
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AST levels were measured using a commercial kit (Pars Azmoon, Tehran, Iran) with enzymatic methods.
4
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Description
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Irisin
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Timepoint
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48 hours before and after 8 weeks of research
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Method of measurement
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Measured using the enzyme-linked immunosorbent assay (ELISA) method with an enzyme immunoassay kit (Phoenix Pharmaceuticals®, Burlingame, USA)
5
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Description
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Insulin
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Timepoint
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48 hours before and after 8 weeks of research
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Method of measurement
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Insulin levels were measured using the enzyme-linked immunosorbent assay (ELISA) method and equipment (ZellBio, Ulm, Germany)
6
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Description
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Glucose
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Timepoint
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48 hours before and after 8 weeks of research
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Method of measurement
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Glucose levels were measured using a commercial kit (Pars Azmoon, Tehran, Iran) with photometric and enzymatic methods.
Intervention groups
1
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Description
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Intervention group: Elastic band resistance training group. This group practiced elastic band resistance training under the supervision of instructors for 8weeks, 3 sessions per week, 60 minutes per session.
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Category
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Treatment - Other
2
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Description
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Control group: No sports activities were involved during the research.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data without participant names
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When the data will become available and for how long
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6 months after publication of the article
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To whom data/document is available
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University students and professors
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Under which criteria data/document could be used
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For future research
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From where data/document is obtainable
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To the researchers of this study
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What processes are involved for a request to access data/document
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By email to researchers
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Comments
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