The Effect of Supplemental Oxygen During Physical Exercise Training on Exercise Capacity in COPD Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Exercise capacity (Watts/kg)
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is number four of the leading causes of death in the USA and Europe. Moreover, among the top five causes of death, this disease is the only one with increasing mortality rates. Physical training has become an evidence based therapeutic intervention in these patients.
In this study the investigators aim to establish if supplemental oxygen during strength and endurance training improves exercise tolerance. Furthermore, the investigators want to research, if supplemental oxygen has the ability to increase training intensity, which would lead to a greater training effect with respect to respiratory, vascular, inflammatory and anthropometric parameters, as well as quality of life.
SCOPE is a prospective, randomized, double-blinded, controlled, cross-over trial. The investigators aim to enroll 40 patients suffering from COPD aged >30 years. Inclusion criteria are FEV1 30-60%, and PO2 at rest >55 mmHg. At baseline, patients will undergo pre-tests including pulmonary, exercise physiological and medical investigations. Prior to the exercise training, an intervention-free control period with usual care is planned. This will be followed by 2 x 6 weeks with physical training (ergometer based endurance training and strength training, using weight lifting machines) with either supplemental oxygen or usual room air (e.g.: first 6 weeks of exercise with oxygen supplementation followed by 6 weeks of room air). After the initial control period and between these two exercise periods, patients will be tested as described in pre-tests, and at the end of the second exercise training period. In addition, the investigators will assess changes in lung function and symptomatic dyspnoea, as well as in quality of life (St. George's Respiratory Questionnaire).
Within this study, the investigators hope to improve rehabilitation programs for COPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD with FEV1 pred. 30 to 60%, PO2 at rest > 55 mmHg and PCO2 < 45 mm Hg
- •age: > 30 years
排除标准
- •Musculoskeletal disease, which prohibits training
- •Relevant neoplastic disease with cachexia
- •Expected non compliance with the study protocol due to drug and alcohol abuse
- •Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
- •Left ventricular ejection fraction < 40 %
- •Renal insufficiency with creatinine > 2 mmol/liter
- •Symptomatic intermittent claudication or peripheral neuropathy
- •Anaemia < 10 mg/dl or red blood count < 3 Mio/mm3
结局指标
主要结局
Exercise capacity (Watts/kg)
时间窗: 6 weeks
To investigate the effectiveness of physical training in COPD- patients comparing a 6 week period of exercise under oxygen supplementation with a 6 week period of exercise under "room air supplementation".
次要结局
- Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.(6 weeks)
- Maximal oxygen uptake (VO2-max)(6 weeks)
- BODE-index(6 weeks)
- Walking capacity(6 weeks)
- Dyspnea(6 weeks)
- Quality of life(6 weeks)
- Body composition(6 weeks)
- Blood parameters of inflammation(6 weeks)
- Vascular changes(6 weeks)
- ten repetition maximum(6 weeks)
研究者
Prof. Josef Niebauer M.D., Ph.D., MBA
Prim. Prof. MD, PhD, MBA
Paracelsus Medical University