Effects and Mechanisms of Supramaximal High-Intensity Interval Training in People With and Without Chronic Obstructive Pulmonary Disease on Extrapulmonary Manifestations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 3
- 主要终点
- Change from baseline global cognitive function
研究概览
简要总结
Beyond pulmonary complications, COPD presents with extrapulmonary manifestations including reduced cognitive, cardiovascular, and muscle function. While exercise training is the cornerstone in the non-pharmacological treatment of COPD, there is a need for new exercise training methods.
The COPD-HIIT trial intend to investigate the effects and mechanisms of 12 weeks supramaximal high-intensity interval-training (HIIT) compared to moderate intensive continous training (MICT) in people with COPD and matched healthy controls on important clinical outcomes.
The trial also intends to compare the effects of 24 months of exercise training (supramaximal HIIT or MICT) to usual care in people with COPD on brain health, cardiorespiratory fitness and muscle power; in people with COPD.
详细描述
COPD-HIIT is a prospective, multi-centre, randomised, controlled, parallel-group superiority trial with assessor and data analyst blinding, featuring a 1:1 allocation ratio and two separate phases. In Phase 1, the trial will investigate the effects and mechanisms of a 12 week intervention with supramaximal HIIT compared to MICT in people with COPD and matched healthy controls. Upon completing the initial 12 week intervention and follow-up assessments, people with COPD, but not healthy controls, will enter Phase 2 of the trial. Phase 2 comprises a 21 month maintenance exercise program. Subsequently, exercise training (supramaximal HIIT or MICT) will be performed until a 24 month follow-up. A separate control group of people with COPD, receiving usual care only, will undergo assessments at baseline and 24-months, making Phase 2 a partially randomized controlled trial.
The primary objectives are:
- to determine and compare the effect of 12-weeks of supramaximal HIIT and MICT on cognitive function, cardiorespiratory fitness, and muscle power in people with COPD compared to matched healthy controls (Phase 1).
- to determine and compare the effect of 24-months of supramaximal HIIT, MICT and usual care on cognitive function, cardiorespiratory fitness and muscle power in people with COPD (Phase 2).
Phase 1 and 2 of the COPD-HIIT project will be performed at two recruiting centres. 1) Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden and Norrlands Universitetssjukhus, and 2) Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium and Ziekenhuis Oost-Limburg (ZOL, Genk, Belgium).
In Phase 1, eligible participants will be randomized to either supramaximal HIIT (intervention arm) or MICT (active control arm) on a stationary bicycle (Smart ZBike, Zycle, Valencia, Spain). For both arms, training is performed two to three times per week for a total of 30 sessions (Table 1) using a group format with groups of 4-8 participants at the same time. Both protocols enable controlled and systematic adjustments of training intensity by means of standardized criteria to achieve a progressive overload
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The outcome assessors and data analysts will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. The dataset will be blinded regarding group allocation when performing analyses.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline global cognitive function
时间窗: Baseline, 12 weeks, 24 months
Global cognitive function will be assessed as the Z-score determined by the combined performances on six tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB) and the trail making test (TMT-A, TMT-B). The following tests from the CANTAB will be used: Motor screening task, reaction time, visual information processing, paired associates learning, spatial working memory, verbal recognition memory. The test battery takes around 60 minutes to complete. The test scores from the seven tests will be combined into a composite Z-score. The Z-score describes how much a point deviates from a mean or specific point. The Z-score represents how many standard deviations an individual's score is from the mean score of the reference population, which is represented as zero.
Change from baseline cardiorespiratory fitness
时间窗: Baseline, 12 weeks, 24 months
Measured as maximum oxygen uptake (VO2peak \[ml O2/min/kg\]) during a standardized ramp-protocol cardiopulmonary exercise test (CPET) on a cycle ergometer. The CPET will start with a 3-minute resting phase before a 3-minute unloaded (or lowest wattage possible) warm-up phase. The aim is to have a ramp-phase of 8-12 minutes, until the participant stops due to voluntarily exhaustion, symptom-limitation or failure to maintain a cadence of 50-70 RPM.
Change from baseline quadriceps muscle power
时间窗: Baseline, 12 weeks, 24 months
Peak power (Nm/s) assessed during a seated leg extension in a dymanometer (Biodex System 4). Participants will be instructed to extend their leg as fast and as hard as possible and then passively return the leg to the starting position.
次要结局
- Change from baseline brain activity(Baseline, 12 weeks, 24 months)
- Change from baseline brain structure(Baseline, 12 weeks, 24 months)
- Change from baseline exercise tolerance(Baseline, 12 weeks, 24 months)
- Change from baseline cognitive function: Motor screening task(Baseline, 12 weeks, 24 months)
- Change from baseline cerebral perfusion(Baseline, 12 weeks, 24 months)
- Change from baseline neuroinflammation(Baseline, 12 weeks, 24 months)
- Change from cardiorespiratory fitness(Baseline, 6 weeks)
- Change from baseline lactate concentration during constant-workload cycle test (CWRT)(Baseline, 6 weeks, 12 weeks, 24 months)
- Change from baseline cognitive function: Reaction time(Baseline, 12 weeks, 24 months)
- Change from baseline cognitive function: Visual information processing(Baseline, 12 weeks, 24 months)
- Change from baseline cognitive function: Spatial working memory(Baseline, 12 weeks, 24 months)
- Change from baseline cognitive function: Paired associates learning(Baseline, 12 weeks, 24 months)
- Change from baseline cognitive function: Executive function(Baseline, 12 weeks, 24 months)
- Change from baseline anaerobic exercise capacity(Baseline, 12 weeks, 24 months)
- Change from baseline cognitive function: Verbal recognition memory(Baseline, 12 weeks, 24 months)
- Change from baseline chronic inflammation(Baseline, 12 weeks, 24 months)
- Change from baseline inflammatory markers(Baseline, 12 weeks, 24 months)
- Change from baseline fibrinogen(Baseline, 12 weeks, 24 months)
- Change from baseline blood cell count(Baseline, 12 weeks, 24 months)
- Change from baseline neurotrophic factors(Baseline, 12 weeks, 24 months)
- Change from baseline metabolic function: Insulin(Baseline, 12 weeks, 24-months)
- Change from baseline quadriceps muscle strength(Baseline, 12 weeks, 24 months)
- Change from baseline quadriceps muscle endurance(Baseline, 12 weeks, 24 months)
- Change from baseline functional performance: Five time sit-to-stand test (5-STS)(Baseline, 12 weeks, 24 months)
- Change from baseline capillary density(Baseline, 12 weeks)
- Change from baseline capillaries sharing factor(Baseline, 12 weeks)
- Change from baseline mitochondrial biogenesis(Baseline, 12 weeks)
- Change from baseline resting lactate(Baseline, 12 weeks, 24 months)
- Change from baseline metabolic function: Glucose(Baseline, 12 weeks, 24-months)
- Change from baseline metabolic function: Insulin resistance(Baseline, 12 weeks, 24-months)
- Change from baseline metabolic function: Glycated hemoglobin(Baseline, 12 weeks, 24-months)
- Change from baseline blood lipid profile(Baseline, 12 weeks, 24-months)
- Change from baseline functional performance: Stair climbing power test(Baseline, 12 weeks, 24 months)
- Change from baseline muscle fibre size(Baseline, 12 weeks)
- Change from baseline proportion of slow and fast subtypes of contractile myosin heavy chain isoforms(Baseline, 12 weeks)
- Change from baseline capillaries to fiber area(Baseline, 12 weeks)
- Change from baseline myofiber and mitochondrial disruption/abnormalities (NADH-TR)(Baseline, 12 weeks)
- Change from baseline enzyme content(Baseline, 12 weeks)
- Change from baseline angiogenesis(Baseline, 12 weeks)
- Change from baseline enzyme activity(Baseline, 12 weeks)
- Change from baseline disease specific quality of life(Baseline, 12 weeks, 6 months, 12 months, 15 months, 18 months, 21 months and 24 months)
- Change from baseline Health related quality of life(Baseline, 12 weeks, 24 months)
- Feasibility of interventions: Attendance rate(12-weeks and 24-months)
- Experiences of exercising and its effects(12 weeks, 24-months)
- Hospitalisations(24 months)
- Change from baseline capillaries per fiber(Baseline, 12 weeks)
- Change from baseline proteins related to muscle-brain cross talk(Baseline, 12 weeks)
- Change from baseline modulation of autonomic cardic function(Baseline, 12 weeks, 24 months)
- Change from baseline epigenetic modifications in blood samples(Baseline, 12 weeks, 24 months)
- Change from baseline blood pressure(Baseline, 12 weeks, 24 months)
- Change from baseline epigenetic modifications in muscle samples(Baseline, 12 weeks)
- Change from baseline body composition(Baseline, 12 weeks, 24 months)
- Change from baseline impact of COPD in daily life(Baseline, 12 weeks, 6 months, 12 months, 15 months, 18 months, 21 months and 24 months)
- Self-percieved change(12 weeks, 24-months)
- Change from baseline state of depression and anxiety(Baseline, 12 weeks, 24 months)
- Number of responders(12 weeks, 24-months)
- Feasibility of interventions: Completion rate(12-weeks and 24-months)
- Feasibility of interventions: Exercise fidelity(Throughout the whole intervention period (24-months))
- Exacerbations(24 months)
- Feasibility of interventions: Adherence to exercise duration and intensity(Throughout the whole intervention period (24-months))
- Feasibility of interventions: Satisfaction(Throughout the whole intervention period (24-months))
- Feasibility of interventions: Affective responses(Throughout the whole intervention period (24-months))
- Adverse events(Throughout the whole intervention period (24-months))
- Mortality(24 months)