Physical Function and Activities of Daily Living in Cancer Patients During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
The study is a randomized controlled trial with the aim to examine the feasibility and the effects of a home-based exercise intervention program on activities of daily living (ADL) in patients with advanced gastrointestinal cancer undergoing chemotherapeutic treatment. Further outcomes include functional and body status, quality of life, body composition, and chemotherapy completion rate. Study participants will be randomized to an exercise intervention group or a wait-list control group
详细描述
A randomised longitudinal study. A total of 44 gastrointestinal cancer patients before their first-line chemotherapy are recruited and randomised into one of two treatment groups A: Home based- physical activity or B: wait-control. The intervention period is 12 weeks. Primary outcome are the ADLs (iADL 1-8; FIM 1-7).Secondary outcomes are the physical activity, quality of life, peripheral polyneuropathy, chemotherapy regimen, gait speed, postural stability, maximal isometric voluntary force of the upper extremity, Maximal isometric voluntary force (MIVF) and strength endurance of the lower extremity, nutritional state, body composition and perceive functional ability. All measurements are standardized and are performed before chemotherapy, after 2 cycles of chemotherapy (4-6weeks) and after 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically classified gastrointestinal cancer
- •UICC III-IV
- •Prior to (planned) first-line chemotherapy (curative und palliative)
- •≥50 years
排除标准
- •ECOG > 2
- •Systemic diseases (MS, ALS)
- •disorders (neurological, skeletal, muscular, mental or cognitive) or drug use (irrespective of the cancer therapy) that may affect gait, balance or muscular strength
- •chronic infection, uncontrolled hypertension (diastolic pressure over 95 mmHg)
- •vestibulopathies
- •uncorrected visual deficits
结局指标
主要结局
Short Physical Performance Battery
时间窗: Change between the first 12 weeks of chemotherapy
Short battery of physical performance tests used to assess lower extremity function. Balance, gait, strength, and endurance are evaluated.
次要结局
- Postural sway(3 times in the course of 12 weeks of chemotherapy)
- Nutrition Assessment(3 times in the course of 12 weeks of chemotherapy)
- Phase angle(3 times in the course of 12 weeks of chemotherapy)
- Body cell mass(3 times in the course of 12 weeks of chemotherapy)
- Perceived functional ability(3 times in the course of 12 weeks of chemotherapy)
- Polyneuropathy(3 times in the course of 12 weeks of chemotherapy)
- Maximum isometric voluntary force of the lower extremity(3 times in the course of 12 weeks of chemotherapy)
- Gait speed(3 times in the course of 12 weeks of chemotherapy)
- Maximum isometric voluntary force of the upper extremity(3 times in the course of 12 weeks of chemotherapy)
- Fat mass(3 times in the course of 12 weeks of chemotherapy)
- Activities of daily living(Change between the first 12 weeks of chemotherapy)
- Daily physical activity(3 times in the course of 12 weeks of chemotherapy)
- Muscular endurance (Chair-Rise Test)(3 times in the course of 12 weeks of chemotherapy)
- Quality of life(3 times in the course of 12 weeks of chemotherapy)
研究者
Prof. Dr. Dr. Winfried Banzer
Head of Department
Goethe University