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Enrolling by invitation Observational

Long-term Effects and Maintenance of Exercise Habits in Individuals With COPD

NCT07870655 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2026-10-15
Last updated
2026-10-13

Condition(s) studied

RehabilitationCOPD (Chronic Obstructive Pulmonary Disease)

Study summary

The study aims to evaluate exercise habits and relevant health outcomes at 6 months and again 12 to 18 months after participation in the COPDEX trial (NCT06551441).

Specifically, we will investigate the extent to which participants maintain regular exercise in the absence of supervision, how long-term exercise behaviour is associated with quality of life and physical capacity, and identify key motivational facilitators and barriers associated with sustained exercise participation

Primary objective is to investigate health-related quality of life in individuals with COPD at 6 months and again 12 to 18 months after participation in the COPDEX trial.

Secondary objectives is to investigate exercise habits, physical activity levels, cardiorespiratory fitness, lung function, functional exercise capacity, and body composition in individuals with COPD 6 months and again 12 to 18 months after participation in the COPDEX trial; to explore differences in long-term outcomes according to original allocation in the COPDEX trial; to identify motivational facilitators and barriers associated with the initiation and maintenance of regular exercise following participation in the COPDEX trial.

At completion of the randomised controlled exercise trial COPDEX (protocol no. H-24021751), which examined the effects of 6 months of high-intensity interval training (HIIT; three sessions per week) compared with usual activity, all participants were encouraged to either continue or initiate regular exercise. All previous participants will be invited to participate in the present follow-up study, irrespective of their original allocation (HIIT group or usual activity group).

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Participated in the clinical trial The COPDEX study. Exclusion criteria Exclusion Criteria: There are no exclusion criteria for participation in the follow-up study. Prior to the study visit, participants will undergo a medical interview and examination. Participants with contraindications to specific study procedures will remain enrolled in the study but will not undergo the relevant assessments. Contraindications to cardiopulmonary exercise are: * Symptoms suggestive of unstable ischaemic heart disease * Acute myocardial infarction within the preceding 3 months * Uncontrolled cardiac arrhythmias * Decompensated heart failure * Severe symptomatic valvular heart disease * Uncontrolled arterial hypertension (\>180/110 mmHg at rest) * Acute pulmonary embolism * Acute respiratory infection or COPD exacerbation within the preceding 2 weeks * Severe musculoskeletal, neurological, or cognitive conditions precluding safe test performance * Any other condition judged by the study physician to make participation unsafe Lung function testing will be performed according to current ATS/ERS recommendations. Contraindications to spirometry and other forced expiratory manoeuvres are: * Acute myocardial infarction within the preceding month * Unstable angina * Recent thoracic, abdominal, cerebral, or ophthalmic surgery where forced expiratory manoeuvres may compromise recovery * Current pneumothorax * Active haemoptysis of unknown origin * Thoracic, abdominal, or cerebral aneurysm judged to be at risk from increased intrathoracic pressure * Acute respiratory infection judged by the study physician to make testing unsafe. * Any other condition judged by the study physician to make testing unsafe Participants unable to perform pulmonary function testing or spirometry may still participate in all other assessments considered safe and feasible.

Primary outcome measure(s)

  • Health-related quality of life — Day 1
    COPD Assessment Test (CAT) score (0-40). Zero means the disease has a no impact on health and 40 means the disease has a worse impact on health.

Trial sites (1)

FacilityCityRegionStatus
Centre for Physical Activity Research, Copenhagen University Hospital Copenhagen Denmark
Official registry record

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.

View NCT07870655 on ClinicalTrials.gov ↗ ← All trials in Denmark