Isulin Resistance as a Mediator of Chronic Pain in Postmenopausal Women: Effects of a Combined Exercise Program on Metabolic and Inflammatory Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Postmenopausal women undergoing a supervised combined exercise program (aerobic, resistance, and mind-body exercise).
干预措施: Combined Exercise Program (Behavioral)
Intervention group
Postmenopausal women undergoing a supervised combined exercise program (aerobic, resistance, and mind-body exercise).
干预措施: Usual Care Group (Other)
Control Group
Postmenopausal women who will continue receiving usual care without participation in a structured exercise program during the study period.
结局指标
主要结局
Pain Intensity
时间窗: 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).
次要结局
- 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)
- Quality of life assessed by Short Form Health Survey (SF-36)(Baseline and after 12 months of intervention)
- Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)(Baseline and after 12 months of intervention)
- Body weight(Baseline and after 12 months of intervention)
- Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA)(Baseline and after 12 months of intervention)
- Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA)(Baseline and after 12 months of intervention)
- Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA)(Baseline and after 12 months of intervention)
研究者
Gabriela Carrion Caldeira Ribeiro
Masters
São Paulo State University