NCT01068210已完成不适用
Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Changes in VO2peak (on Exercise Capacity)
研究概览
简要总结
The purpose of the study is look at the effects of different types of exercise training with a stretching group and its effect on lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic & resistance, or a control group. Pre and Post testing will include stress tests, echos, blood, and urine samples.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of study-related procedures
- •Age 21 - 80 years
- •Weight < 205 kgs
- •Diagnosed with histologically confirmed lung cancer, regardless of disease stage and receiving any prior line of any therapy in the context of metastatic disease
- •An interval of at least three months following the completion of primary resection, if appropriate
- •An interval of no longer than ten years following completion of primary therapy, if appropriate
- •Life expectancy ≥ 4 months
- •Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week
- •Exercise intolerance (i.e., patients must have a VO2peak below that predicted for active age and sex-matched individuals)
- •Willing to be randomized to one of the study arms
- •Willing to commit to the study program and comply with all related protocol procedures
- •Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
- •achieving a plateau in oxygen consumption, concurrent with an increase in power output;
- •a respiratory exchange ratio ≥ 1.10;
- •attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
- •volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
- •Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the PI.
- •Ability to achieve and complete an acceptable baseline one-repetition maximum muscular strength test as defined by the effective execution of protocol-specific joint and muscle ranges of motion without remarkable signs or symptoms of pain, discomfort or distress.
排除标准
- •Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
- •Room air desaturation at rest ≤ 85%;
- •Mental impairment leading to inability to cooperate.
- •Any of the following absolute contraindications to cardiopulmonary exercise testing:
- •Acute myocardial infarction (within 3-5 days of any planned study procedures);
- •Unstable angina;
- •Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
- •Recurrent syncope;
- •Active endocarditis;
- •Acute myocarditis or pericarditis;
- •Symptomatic severe aortic stenosis;
- •Uncontrolled heart failure;
- •Acute (within 3 months) pulmonary embolus or pulmonary infarction;
- •Thrombosis of lower extremities;
- •Suspected dissecting aneurysm;
- •Uncontrolled asthma;
- •Pulmonary edema;
- •Respiratory failure;
- •Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
结局指标
主要结局
Changes in VO2peak (on Exercise Capacity)
时间窗: 17 weeks
To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)
次要结局
未报告次要终点
研究者
研究点 (1)
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