Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Endurance shuttle walk test (ESWT)
研究概览
简要总结
Pulmonary rehabilitation (PR) including exercise training is highly effective by improving health-related quality of life, exercise capacity and symptoms in patients with chronic obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a 3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)[1]. These between-group differences were mirrored by missing adaptations of the fatigue-resistant skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial because it enables patients for physical endurance activities (walking, cycling etc.) during their daily life.
The aim of this study is to compare the effects of an exercise Training program with high vs. moderate Training intensity in order to find a Training modality which improves Training effects in A1ATD patients.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients with A1ATD (genotype PiZZ)
- •COPD patients without A1ATD (genotype PiMM)
- •Global initiative for chronic obstructive lung disease (GOLD) stage III-IV
- •Medical Treatment according to recent A1ATD guidelines
排除标准
- •General exclusion criteria for physical Training such as acute coronary Syndrome, acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic comorbidities which prevent patients from participating in exercise Training program.
- •No written informed consent
- •Non-compliance
研究组 & 干预措施
High training intensity
Exercise Training with high intensities consists of a cycling Interval Training at 100% of the individual Peak work rate, resistance Training for 3 sets à 8 repetitions and squats on a Vibration plate.
干预措施: Exercise training (Procedure)
moderate training intensity
Exercise Training with moderate intensities consists of a cycling endurance Training at 60% of the individual Peak work rate, resistance Training for 3 sets à 20 repetitions and squats on the floor.
干预措施: Exercise training (Procedure)
结局指标
主要结局
Endurance shuttle walk test (ESWT)
时间窗: Change in the duration of the ESWT from day 1 to day 21
The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.
次要结局
- Oxygen saturation(Change in the oxygen saturation at isotime from day 1 to day 21)
- Lactate concentration(Change in lactate concentration at isotime from day 1 to day 21)
- Perceived Dyspnea(Change in perceived dyspnea at isotime from day 1 to day 21)
- Heart rate(Change in the heart rate at isotime from day 1 to day 21)
- Partial pressure of carbon dioxide (CO2)(Change in the partial pressure of CO2 at isotime from day 1 to day 21)
- Strength capacity in knee extension(Change in strength from day 1 to day 21)
- Balance performance(Change in balance performance from day 1 to day 21)
研究者
Klaus Kenn
Head physician
Schön Klinik Berchtesgadener Land