Exercise training on a stationary bicycle: Training is performed two to three times per week for a total of 30 sessions using a group format.
Both regimens start with a five-minute warm-up and ends with a five-minute cool-down, performed at an intensity corresponding to 30% of the maximal work rate achieved during a CPET (i.e., max aerobic power \[MAP\]) with a self-selected pedalling cadence of 50-70 revolutions per minute (RPM).
All exercise sessions will be held and supervised by an experienced health care professional, i.e. physiotherapists or other health professional.
The different types of exercise training is described under the specific arm.
Following the first 12-week training period, participants with COPD will enter a 21-month maintenance phase. They will continue to exercise using the same training modality (HIIT or MICT) as during the first 12-weeks but can select between three different settings to continue their training: "Home", "Outpatient", or "Mix" setting.
Study summary
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.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
The inclusion criteria are:
1. 60 years of age or older
2. Independent in activities of daily living
3. For people with COPD: Symptomatic (COPD assessment test \[CAT\] ≥10 or modified Medical Research Council dyspnea scale \[mMRC\] ≥2) or not being regularly physically active at a moderate or high intensity over the last year defined as not meeting WHO requirements for physical activity.
4. For people with COPD: Post-bronchodilator spirometry confirmed COPD diagnosis (forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio \< 0.70).
5. For healthy controls: Normal lung function
The exclusion criteria are:
1. Movement related conditions, cardiovascular, neuromuscular, metabolic, skeletal and/or rheumatic conditions and diseases that are unstable and/or prohibits exercise or tests, based on screening by a physician. For example, but not limited to:
I. Musculoskeletal pain prohibiting participation in tests and exercise II. Recent myocardial infarction, coronary artery bypass grafting, angioplasty, or other cardiac events III. Uncontrolled arterial hypertension IV. Pathological ECG-findings during CPET
2. Other lung conditions, including, but not limited to asthma, interstitial lung disease, lung cancer, pulmonary hypertension, pulmonary vascular disease, pulmonary fibrosis
3. Medical conditions and treatments with known effects on brain function and cognition, for example:
I. Previous trauma to the head with lasting cognitive or symptom-related issues II. Physical or mental disabilities III. Neurological condition (dementia, multiple sclerosis, stroke) IV. Psychiatric illness, not including depression or general anxiety disorder V. Severe cognitive impairment VI. Recent or current cancer diagnosis and treatment
4. For those accepting MRI or PET/CT: metal implants, pacemakers, claustrophobia and other MRI incompatible factors.
5. Inability to read or speak Swedish (Umeå participants), Dutch, French (Hasselt participants) or English (Umeå and Hasselt participants).
6. For people with COPD:
I. Co-morbid conditions that limit exercise performance to a greater extent than the COPD diagnosis.
II. Currently participating in a pulmonary rehabilitation program or have been involved in pulmonary rehabilitation in the last 12 months.
III. Experienced a COPD exacerbation that led to a change in medication dosage or frequency in the preceding six weeks.
Primary outcome measure(s)
Change from baseline global cognitive function — 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 — 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 — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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