Exercise in Lung Cancer Patients - Specific Training, Muscle Mass and Force Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Muscle strength/function: Rate of Force Development (RFD)
研究概览
简要总结
This study evaluates the effectiveness of a supervised one-leg resistance training program in patients with inoperable lung cancer with the primary outcome being rate of force development.
Study design: Single center, two-armed, parallel-group, randomized controlled trial. The primary outcome being rate of force development after 12 weeks of progressive resistance training.
详细描述
Muscular dysfunction and sarcopenia are known phenomena in cancer patients, and patients experience reduced muscle function and muscle loss regardless of cancer type or stage. Studies indicate that there are a number of cancer-specific and non-cancer-specific factors that influence muscle dysfunction, such as age, poor nutrition, physical inactivity, cancer pathology and treatment preparations. The decreased muscle function can ultimately lead to cachexia, typically seen in stage III - IV lung cancer patients.
Previous studies have focused on 1-RM tests, muscle mass and functionality as outcomes. However, a central aspect of functionality in lung cancer patients may be the muscle's ability to develop force in a short time. The present study therefore has rate of force development as a primary outcome with muscle mass and functionality as supporting outcomes. In addition, the patients in this study will perform one-leg resistance exercise with the other leg as the control leg. This will eliminate the interpersonal bias normally seen in randomized controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •patients (men and women) from the age of 18 years and above; patients with lung cancer (NSCLC stage III - IV and SCLC ED); patients with performance stage 0-2 according to WHO criteria
排除标准
- •Patients where the doctor has listed contraindications for physical activity in the medical record; documented bone and brain metastases; persistent medullary plasia; patients on anticoagulation treatment; diagnosed symptomatic cardiac disease, including clinical congestive heart disease, arrhythmia requiring treatment or diagnosed myocardial infarction within the last three months; pericardial exudate; patients in terminal treatment; senile dementia and psychotic patients.
结局指标
主要结局
Muscle strength/function: Rate of Force Development (RFD)
时间窗: Baseline, 6 weeks, 12 weeks
The between group change in Rate of Force Development (Nm/s) of the knee extensors. Assessed in the CON-TREX MJ dynamometer.
次要结局
- Functionality: 6 minutes walk test (6-MWT)(Baseline, 6 weeks, 12 weeks)
- Functionality: Sit-to-stand (5reps STS)(Baseline, 6 weeks, 12 weeks)
- Functionality: Sit-to-stand (30s STS)(Baseline, 6 weeks, 12 weeks)
- Muscle strength/function: Isokinetic strength(Baseline, 6 weeks, 12 weeks)
- Lean leg mass(Baseline, 6 weeks, 12 weeks)
- Muscle strength/function: Power(Baseline, 6 weeks, 12 weeks)
- Functionality: Postural balance(Baseline, 6 weeks, 12 weeks)
- Muscle strength/function: 1 RM(Baseline, 6 weeks, 12 weeks)
研究者
Morten Quist
Associate Professor
Rigshospitalet, Denmark