NCT06068322Recruiting
Supramaximal High-Intensity Interval Training in People With and Without Chronic Obstructive Pulmonary Disease
Effects and Mechanisms of Supramaximal High-Intensity Interval Training in People With and Without Chronic Obstructive Pulmonary Disease on Extrapulmonary Manifestations
Source: ClinicalTrials.gov · Last updated 23 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- First submitted
- 26 Jun 2023
- Start date
- 9 Nov 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Umeå University
- Diseases
- COPD
- NCT number
- NCT06068322
What you commit to
- Study type: Interventional
- Planned participants: 208
- From 9 Nov 2023 to the primary completion date, Dec 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- The inclusion criteria are:
- 60 years of age or older
- Independent in activities of daily living
- 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.
- 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).
- For healthy controls: Normal lung function
- The exclusion criteria are:
- 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:
- 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
- Other lung conditions, including, but not limited to asthma, interstitial lung disease, lung cancer, pulmonary hypertension, pulmonary vascular disease, pulmonary fibrosis
- Medical conditions and treatments with known effects on brain function and cognition, for example:
- 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
- For those accepting MRI or PET/CT: metal implants, pacemakers, claustrophobia and other MRI incompatible factors.
- Inability to read or speak Swedish (Umeå participants), Dutch, French (Hasselt participants) or English (Umeå and Hasselt participants).
- For people with COPD:
- Co-morbid conditions that limit exercise performance to a greater extent than the COPD diagnosis.
- Currently participating in a pulmonary rehabilitation program or have been involved in pulmonary rehabilitation in the last 12 months.
- Experienced a COPD exacerbation that led to a change in medication dosage or frequency in the preceding six weeks.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hasselt University Coordinator of this site? Confirm its status | Hasselt | Belgium | Recruiting |
| Umeå University Coordinator of this site? Confirm its status | Umeå | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.