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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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