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

NCT07407699 | Not Yet Recruiting DMC

• 1 other identifier: DOUTORADO_FCT_UNESP_2026
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain; Postmenopausal; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  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 Outcomes (11)

• Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline (pre-intervention) and after 12 months of intervention

• Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)

  Baseline and after 12 months of intervention

• Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)

  Baseline and after 12 months of intervention

• Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS)

  Baseline and after 12 months of intervention

• Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ)

  Baseline and after 12 months of intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Postmenopausal women undergoing a supervised combined exercise program (aerobic, resistance, and mind-body exercise).

Behavioral: Combined Exercise Program; Other: Usual Care Group

Control Group

NO INTERVENTION

Postmenopausal women who will continue receiving usual care without participation in a structured exercise program during the study period.

Interventions

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.

Intervention group

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.

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• São Paulo State University: lead

MeSH Terms

Conditions

Chronic Pain; Insulin Resistance

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Gabriela Ribeiro

CONTACT

55+18996921106; gabrielacarrion123@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02