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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Другое 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.

Первичные конечные точки

• Pain Intensity [Срок оценки: Baseline and at 12 months following intervention]

Вторичные конечные точки (11)

• Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Срок оценки: Baseline (pre-intervention) and after 12 months of intervention]
• Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) [Срок оценки: Baseline and after 12 months of intervention]
• Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) [Срок оценки: Baseline and after 12 months of intervention]
• Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline and after 12 months of intervention]
• Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: Baseline and after 12 months of intervention]
• Quality of life assessed by Short Form Health Survey (SF-36) [Срок оценки: Baseline and after 12 months of intervention]
• Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline and after 12 months of intervention]
• Body weight [Срок оценки: Baseline and after 12 months of intervention]
• Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA) [Срок оценки: Baseline and after 12 months of intervention]
• Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA) [Срок оценки: Baseline and after 12 months of intervention]
• Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA) [Срок оценки: Baseline and after 12 months of intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07407699 · DOUTORADO_FCT_UNESP_2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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