Exercise, Insulin Resistance, and Chronic Pain in Postmenopausal Women.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined Exercise Program, Usual Care Group.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Postmenopausal, Insulin Resistance. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Isulin Resistance as a Mediator of Chronic Pain in Postmenopausal Women: Effects of a Combined Exercise Program on Metabolic and Inflammatory Mechanisms
Overview
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.
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.
Interventions
- 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-bo - 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.
Primary outcome measures
- Pain Intensity [Time frame: Baseline and at 12 months following intervention]
Secondary outcome measures (11)
- Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: 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]
- Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) [Time frame: 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 self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ) [Time frame: 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]
- Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline and after 12 months of intervention]
- Body weight [Time frame: 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]
- Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA) [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07407699 · DOUTORADO_FCT_UNESP_2026