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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
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.
Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline and at 12 months following intervention
Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance will be evaluated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels.
Time frame: Baseline (pre-intervention) and after 12 months of intervention
Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
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.
Time frame: Baseline and after 12 months of intervention
Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
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.
Time frame: Baseline and after 12 months of intervention
Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), ranging from 0 to 52, with higher scores indicating greater catastrophizing.
Time frame: Baseline and after 12 months of intervention
Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ)
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.
Time frame: Baseline and after 12 months of intervention
Quality of life assessed by Short Form Health Survey (SF-36)
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.
Time frame: Baseline and after 12 months of intervention
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline and after 12 months of intervention
Body weight
Body weight will be measured using a calibrated scale and expressed in kilograms (kg).
Time frame: Baseline and after 12 months of intervention
Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA)
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.
Time frame: Baseline and after 12 months of intervention
Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA)
Total fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and expressed in kilograms (kg).
Time frame: Baseline and after 12 months of intervention
Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA)
Total lean mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and expressed in kilograms (kg). Higher values indicate greater lean mass.
Time frame: Baseline and after 12 months of intervention
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