Exercise, Insulin Resistance, and Chronic Pain in Postmenopausal Women. (EX-PAIN-MENO)

February 5, 2026 updated by: Gabriela Carrion Caldeira Ribeiro, São Paulo State University

Isulin Resistance as a Mediator of Chronic Pain in Postmenopausal Women: Effects of a Combined Exercise Program on Metabolic and Inflammatory Mechanisms

This study aims to investigate the effects of a combined exercise program on chronic pain in postmenopausal women, considering insulin resistance as a potential physiological mediator. The intervention will assess changes in pain intensity, metabolic and inflammatory biomarkers, psychosocial factors, and body composition. The findings may contribute to understanding the metabolic mechanisms underlying chronic pain in postmenopausal women and support exercise as a non-pharmacological therapeutic strategy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Postmenopausal women experience a high prevalence of chronic musculoskeletal pain, potentially influenced by hormonal depletion, metabolic dysfunction, and low-grade systemic inflammation. Insulin resistance has been associated with inflammatory processes and may contribute to peripheral and central sensitization mechanisms involved in chronic pain.

This randomized controlled trial will evaluate the effects of a combined exercise intervention, including aerobic, resistance, and mind-body components, on pain intensity and related outcomes in postmenopausal women with chronic pain. Secondary outcomes include metabolic markers, inflammatory biomarkers, psychosocial variables, and body composition. Insulin resistance will be explored as a mediator of pain modulation following the exercise intervention.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal women, defined as between 12 months and 5 years since the last menstrual period.
  • Not using hormone replacement therapy.
  • Not engaged in regular physical exercise (defined as more than once per week in the last months).
  • With or without insulin resistance.

Exclusion Criteria:

  • Diagnosis of neurological diseases (e.g., Parkinson's disease, multiple sclerosis, or stroke sequelae).
  • Severe psychiatric disorders.
  • Inflammatory autoimmune diseases (e.g., rheumatoid arthritis or systemic lupus erythematosus).
  • Active neoplasms.
  • Use of systemic corticosteroids or immunosuppressive drugs within the last three months.
  • Severe decompensated cardiovascular disease.
  • Any medical condition that contraindicates participation in physical exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Postmenopausal women undergoing a supervised combined exercise program (aerobic, resistance, and mind-body exercise).
Behavioral: Combined Exercise Program

Participants allocated to the intervention group will take part in a supervised combined exercise program, performed twice weekly for 12 months. Each session will last approximately 60 minutes and will include aerobic exercise, resistance training, and mind-body exercise.

Aerobic training will consist of walking or cycling at moderate intensity, monitored by heart rate. Resistance training will involve multi-joint exercises using body weight and elastic bands, with progressive overload. Mind-body exercise will be performed using restorative yoga techniques. Exercise sessions will be supervised by a trained physiotherapist.

Other: Usual Care Group
Participants allocated to the control group will continue with their usual care and daily activities, without participation in any structured or supervised exercise program during the study period.
No Intervention: Control Group
Postmenopausal women who will continue receiving usual care without participation in a structured exercise program during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline and at 12 months following intervention
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain).
Baseline and at 12 months following intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline (pre-intervention) and after 12 months of intervention
Insulin resistance will be evaluated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels.
Baseline (pre-intervention) and after 12 months of intervention
Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
Time Frame: Baseline and after 12 months of intervention
Anxiety symptoms will be assessed using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.
Baseline and after 12 months of intervention
Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time Frame: Baseline and after 12 months of intervention
Depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D), ranging from 0 to 21, with higher scores indicating greater depressive symptoms.
Baseline and after 12 months of intervention
Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS)
Time Frame: Baseline and after 12 months of intervention
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), ranging from 0 to 52, with higher scores indicating greater catastrophizing.
Baseline and after 12 months of intervention
Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Baseline and after 12 months of intervention
Self-efficacy related to pain management will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ), ranging from 0 to 60, with higher scores indicating greater self-efficacy.
Baseline and after 12 months of intervention
Quality of life assessed by Short Form Health Survey (SF-36)
Time Frame: Baseline and after 12 months of intervention
Quality of life will be assessed using the Short Form Health Survey (SF-36), with scores ranging from 0 to 100, where higher scores indicate better health-related quality of life.
Baseline and after 12 months of intervention
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline and after 12 months of intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 21, with higher scores indicating worse sleep quality.
Baseline and after 12 months of intervention
Body weight
Time Frame: Baseline and after 12 months of intervention
Body weight will be measured using a calibrated scale and expressed in kilograms (kg).
Baseline and after 12 months of intervention
Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA)
Time Frame: Baseline and after 12 months of intervention
Body fat percentage will be assessed using dual-energy X-ray absorptiometry (DEXA). Values will be expressed as percentage (%), with higher values indicating greater body fat.
Baseline and after 12 months of intervention
Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA)
Time Frame: Baseline and after 12 months of intervention
Total fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and expressed in kilograms (kg).
Baseline and after 12 months of intervention
Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA)
Time Frame: Baseline and after 12 months of intervention
Total lean mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and expressed in kilograms (kg). Higher values indicate greater lean mass.
Baseline and after 12 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

São Paulo State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOUTORADO_FCT_UNESP_2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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