PRIME - Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maximum oxygen uptake - VO2peak
研究概览
简要总结
The aim of this study is to evaluate the feasibility and the effect of daily, individual, supervised and structured exercise training before radiotherapy in patients diagnosed with Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The hypotheses are that patients who undergo daily exercise training will increase VO2peak, functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired volume in one second (FEV1)).
详细描述
Pre intervention screening: Each patient was screened by a clinical nurse specialist prior to participating in the study. Before baseline and post test the patient was screened by a research physiotherapist and/or human physiology students. If one of the following criteria were met, the patient was prohibited from being tested on that day: diastolic blood pressure <45 or >95, heart rate (HR) at rest >115/min, temperature > 38 0C, respiratory rate at rest >30/min, infection requiring treatment, fresh bleeding, total leucocyte count <1.0 109/L or platelets <50 109/L.
Control - Usual care: The patients randomized to the control group received no training but conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires) just as the intervention group. Furthermore, patients in control were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.
Intervention - The patients randomized to the intervention group received daily training and conducted baseline and post test (6MWD, spirometry, VO2peak and questionnaires). Furthermore, patients were equipped with a Garmin vivo-smart HR® activity tracker every day in 24h during the course of radiotherapy treatment.
The supervised daily training was carried out individually and each session had a duration of 20 minutes before patients individual prescribed radiotherapy. Training was conducted at National Hospital of Denmark: Department of Radiation Oncology , section 3981, entry 39. supervised by a research physiotherapist and/or human physiology students.
Statistical analysis sample size: According to the sample size the calculation is performed on the basis of alteration in VO2peak from the study "EXHALE" (55 patients who completed a 6 weeks training period). The calculation is based on an increase of 200 ml/min in VO2peak for patients in the intervention group (SD = 2,48) and it is assumed that the patients in the control group will have a reduction of 100 ml/min (SD = 2,48). Assumptions for calculation of patient numbers are as follows: Type 1 error 0.05, type 2 error 0.20, SD 2.48.
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
- 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
- •Patients with NSCLC who are treated with concomitant chemo- and radiotherapy.
- •Age: > 18 year
- •WHO performance status 0-1
排除标准
- •Patients with any symptoms or circumstances that advise against physical activity.
- •Symptomatic heart disease e.g. arrhythmia or myocardial infarction within the last three months.
- •Congestive heart failure
- •Patients who do not read and speak Danish.
- •Brain or bone metastases;
- •Prolonged bone marrow suppression
- •Anti-coagulant treatment
- •Inability to provide informed consent.
结局指标
主要结局
Maximum oxygen uptake - VO2peak
时间窗: Change from baseline at 7 weeks
The primary outcome will be VO2peak, assessed with an aerobic capacity (VO2peak) incremental cycle ergometer test performed on a Monark ergometer 839E cycle. At baseline, human physiology students will carry out the incremental cycle test. A physiotherapist who is blinded to the groups wherein the patients are allocated will carry out the posttest. The test consist of a warm-up phase at 10-50 w. After warm-up the load increases by 5-10 w every 60 sec until exhaustion or a possible symptom limitation (e.g. dizziness, sudden pain, vomiting sensation). To analyze the expired gases patients are going to wear a Hans Rudolf Mask during the test. Expired gases will be analyzed continuously by a metabolic breath-by-breath analysis and calculated as an average over 15 sec using the Oxycon Pro. Jaeger measurement system.
次要结局
- Cardiac output(Baseline, selected test samples during training intervention and 7 weeks)
- Hypoxia in tumor(Baseline and 7 weeks)
- Rated Perceived Exertion (RPE) Scale(Change from baseline at 7 weeks)
- Stroke volumen(Baseline, selected test samples during training intervention and 7 weeks)
- Respiratory exchange ratio (RER)(Change from baseline at 7 weeks)
- Functional capacity(Baseline and 7 weeks)
- Safety: Sports-injury, Pain, Neuropathies, Nausea/vomiting, Fatigue etc.(Baseline, during intervention and 7 weeks)
- Forced Expiratory Volume in one second(Baseline and 7 weeks)
- Lung Function(Baseline and 7 weeks)
- Systemic vascular resistance(Baseline, selected test samples during training intervention and 7 weeks)
研究者
Morten Quist
Principal Investigator
Rigshospitalet, Denmark