High-Intensity Interval Training for COPD and Healthy Individuals

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

This study is testing whether a special type of intense exercise can help people with COPD and healthy individuals improve their thinking skills, fitness, and muscle strength over 12 weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Umeå University (Academic / other)
• Locations: 2 sites (Hasselt, Diepenbeek and 1 other locations)
• Trial ID: NCT06068322 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of supramaximal high-intensity interval training (HIIT) compared to moderate-intensity continuous training (MICT) over 12 weeks in individuals with chronic obstructive pulmonary disease (COPD) and matched healthy controls. The study aims to assess improvements in cognitive function, cardiorespiratory fitness, and muscle power. Following the initial phase, participants with COPD will continue with a 24-month maintenance program to evaluate long-term benefits. The trial is designed as a multi-centre, randomized, controlled trial with blinding for assessors and data analysts.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 60 and older with symptomatic COPD or healthy individuals with normal lung function.

Not a fit: Patients with unstable cardiovascular, neuromuscular, or other serious conditions that prohibit exercise may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance physical and cognitive health outcomes for patients with COPD.

How similar studies have performed: Previous studies have shown positive outcomes with high-intensity interval training in various populations, suggesting potential success for this approach in COPD.

Eligibility criteria

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.

Where this trial is running

Hasselt, Diepenbeek and 1 other locations

• Hasselt University — Hasselt, Diepenbeek, Belgium (Recruiting)
• Umeå University — Umeå, Sweden (Recruiting)

Study contacts

• Principal investigator: André Nyberg, PhD — Umeå University
• Study coordinator: André Nyberg, PhD

Conditions COPD; Healthy Controls; Chronic obstructive Pulmonary Disease; Pulmonary Disease, Chronic Obstructive; Chronic airway disease; physical activity; exercise