Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD: a Randomized Controlled Trial (the COPDEX Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pulmonary blood volume (mL) at rest
研究概览
简要总结
The aim of this prospective randomised controlled trial in which the impact of high intensity interval training (HIIT) on pulmonay blood volume, pulmonary gas exchange during exercise, and lung tissue mass.
The primary objective is to investigate whether 6 months of supervised HIIT leads to an increase in pulmonary blood volume in patients with COPD with a concomitant improvement in pulmonary gas exchange.
Key objectives are to determine whether an increase in pulmonary blood volume is associated with the formation of new lung tissue. Other secondary objectives include investigating the effect of supervised HIIT on formation of lung tissue, symptom severity, pulmonary gas exchange at supine rest and on pulmonary blood volume at rest. Finally, exploratory objectives include investigating the effects of HIIT on lung function, V̇O2peak, functional outcomes, body composition, blood samples and cardiac output.
Participants will be randomly allocated (1:1) stratified by sex to either
- 24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or
- A control group who will not undergo HIIT training. The control group will be encouraged not to change their exercise or eating habits.
The participants will visit the clinic pre- and post the intervention. Exercise habits, adverse events, hospital admisseions, infections and medications will be assessed by phone at week 4, 8, 12, 16, 20 and at follow-up visit. All participants will undergo 24-h accelerometry for five consecutive days to measure posture allocation and daily physical activity behavior. The devices will be attached just before the randomization, after one month, at 12 weeks and just before the 6 months testing.
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
- •Men and women
- •Age >=40 and <80 years
- •COPD (GOLD stage I to III)
- •Modified Medical Research Council score (mMRC) of 0 to 3
- •Resting arterial oxygenation > 90%
排除标准
- •Symptoms of ischaemic heart disease
- •Known heart failure
- •Unable to complete or understand HIIT training
- •Claudication
- •Symptoms of disease within 2 weeks prior to the study
- •Participation in pulmonary rehabilitation within 3 months
- •Known malignant disease
- •Pregnancy
- •Unstable cardiac arrhythmic disease
- •Renal or liver dysfunction
- •Known chronic kidney or liver disease
- •Elevated creatinine, urea, alanine transaminase (ALAT), aspartate transaminase (ASAT), bilirubin, basic phosphatases at blood test
- •Completion of pulmonary rehabilitation within the last 3 months
研究组 & 干预措施
Exercise
The HIIT intervention includes three supervised sessions per week over a 24-week period i.e., 72 exercise sessions and take place at CFAS or at home with supervision
干预措施: High Intensity Interval Training (HIIT) (Behavioral)
Control group
Controls will be encouraged to maintain current exercise habits for the duration of the study.
结局指标
主要结局
Pulmonary blood volume (mL) at rest
时间窗: 6 months
Difference in change from baseline to six months between groups in pulmonary blood volume (mL) at rest
次要结局
- DL,NO (mmol/(min kPa)) as a function of V̇O2 measured at rest(6 months)
- Total LTM (g)(6 months)
研究者
Ronan Berg
MD, DMSc, Associate Professor
Rigshospitalet, Denmark