Phase II Randomized Controlled Trial of Rapid and Easy Strength Training to Preserve Function in Late Stage Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Ambulatory Post Acute Care Basic Mobility Short Form
研究概览
简要总结
The purpose of this study is to determine whether a gentle physical conditioning program comprised of isotonic resistive strengthening and pedometer-directed walking can improve the physical functioning and fatigue of patients with late stage lung or colon cancer.
详细描述
A. SPECIFIC AIMS
The results of this prospective pilot cohort study will be used to power and inform the design of a randomized controlled trial. Its specific aims are:
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To characterize the receptivity of patients with late stage lung or colon cancer to perform an individualized fitness program to prevent deconditioning and functional decline.
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To estimate the adherence of patients with LSC (LSC) to an individualized fitness program.
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To estimate the degree to which symptoms, e.g. fatigue and pain, associate with adherence to an individualized fitness program.
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To estimate improvements in functional status associated with performance of an individualized fitness program among patients with LSC.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Stage III or IV NSCLC or extensive stage SCLC, or Stage IV colon cancer
- •fluency in the English language
- •Intact cognitive status (Folstein mini-mental score > 25).
排除标准
- •Pain numeric rating scale (NRS) scores > 7/10,
- •Fatigue NRS score > 8/10,
- •paralysis of > 2 limbs (< antigravity strength in all major muscle groups),
- •Severe cerebellar ataxia,
- •Chronic (> 1 year) non-cancer pain either >5/10 or causing the patient to apply for or receive disability payments.
- •Severe medical or psychiatric co-morbidities such as major depression or unstable angina
结局指标
主要结局
Ambulatory Post Acute Care Basic Mobility Short Form
时间窗: 8 weeks
Patient reported outcome with 18 items assessed functionality in basic mobility. Response option for all items is a 4 level Likert scale
次要结局
- Ambulatory Post Acute Care Short Form Daily Activities(8 weeks)
- FACIT-F(8 weeks)
- Linear Analoge Self Assessment of Quality of Life(8 weeks)