Chronic Pain, Insulin Resistance, Postmenopausal
Conditions
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.
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
BEHAVIORALCombined 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.
OTHERUsual 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.
Sponsors
São Paulo State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 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. |
| Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) | 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. |
| Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) | 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. |
| Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS) | 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. |
| Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ) | 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. |
| Quality of life assessed by Short Form Health Survey (SF-36) | 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. |
| Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Body weight | Baseline and after 12 months of intervention | Body weight will be measured using a calibrated scale and expressed in kilograms (kg). |
| Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA) | 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. |
| Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA) | 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). |
| Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA) | 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. |
Contacts
CONTACTGabriela Ribeiro
Outcome results
None listed