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RECRUITING

NCT06068322

Supramaximal High-Intensity Interval Training in People With and Without Chronic Obstructive Pulmonary Disease

Sponsor: Umeå University

View on ClinicalTrials.gov

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.

Official title: Effects and Mechanisms of Supramaximal High-Intensity Interval Training in People With and Without Chronic Obstructive Pulmonary Disease on Extrapulmonary Manifestations

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2023-11-09

Completion Date

2028-12

Last Updated

2024-05-23

Healthy Volunteers

Yes

Conditions

COPD Healthy Controls

Interventions

OTHER

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.

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.

Locations (2)

Hasselt University

Hasselt, Diepenbeek, Belgium

Umeå University

Umeå, Sweden