A RENEW Intervention for Elderly Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Patient perception and pattern of change
研究概览
简要总结
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
详细描述
OBJECTIVES:
- Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
- Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
- Evaluate the patient's adherence to and satisfaction with the RENEW intervention.
OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
- Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease
- •At least moderate levels of fatigue and/or weakness
- •Impaired mobility but ambulatory and medically able to participate in an exercise regimen
- •No impaired knee flexion, defined as < 90º
- •PATIENT CHARACTERISTICS:
- •Folstein Mini-Mental Status Examination score ≥ 23
- •No extreme claustrophobia
- •No diagnosed chronic fatigue syndrome/disorder
- •No neurological impairments, including the following:
- •Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease)
- •Neurological insult (cerebrovascular attack) that manifests in a mobility disorder
- •No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function
- •No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica)
- •PRIOR CONCURRENT THERAPY:
- •More than 6 months since prior regular aerobic or resistance exercise
- •Regular exercise defined as 2-3 times per week
- •At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy )
- •No concurrent cancer-related treatment other than hormonal therapy
排除标准
- 未提供
结局指标
主要结局
Patient perception and pattern of change
时间窗: 3 months of training followed by 6 and 12 months of no formal training
To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status
次要结局
- Structural and function changes(3 months of training followed by 6 and 12 months of no formal training)