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NCT Number: NCT07407699

Exercise, Insulin Resistance, and Chronic Pain in Postmenopausal Women.

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.

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Key information

Conditions

Chronic Pain Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Postmenopausal Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined Exercise Program

Behavioral

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.

Usual Care Group

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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).

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Ribeiro

CONTACT

[email protected]

55+18996921106

Sponsors and collaborators

Lead sponsor

São Paulo State University

Other

Registry information

Official study title

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

Acronym: EX-PAIN-MENO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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