Health Haven: Comprehensive maintenance program for COPD in Lleida (NAPOLEON)
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
This 12-month randomized trial will test whether a supervised, multidimensional maintenance pulmonary rehabilitation program helps adults with moderate to severe COPD keep symptom relief and quality-of-life gains after their initial rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Institut de Recerca Biomèdica de Lleida Academic / other |
| Locations | 2 sites (Lleida, Catalonia and 1 other locations) |
| Trial ID | NCT07394712 on ClinicalTrials.gov |
What this trial studies
Adults with moderate to severe COPD who have completed the initial outpatient pulmonary rehabilitation program are randomized to a supervised, multidimensional maintenance pulmonary rehabilitation program or usual care for 12 months. The intervention is delivered in an outpatient setting coordinated by a physiotherapist and includes supervised exercise, education, and ongoing support. Outcomes include symptoms, health-related quality of life, exercise capacity, healthcare resource use, economic measures, and participant perceptions. The design aims to compare clinical and health-system effects of a structured maintenance strategy versus routine follow-up.
Who should consider this trial
Good fit: Adults aged 40–75 with confirmed moderate to severe COPD who are clinically stable and have completed at least 6 of 8 sessions of an initial outpatient pulmonary rehabilitation program.
Not a fit: Patients with unstable cardiovascular conditions, recent surgery, severe musculoskeletal or neurological limitations, or those unable to attend supervised outpatient sessions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could help people with COPD maintain lower breathlessness, better exercise capacity, improved quality of life, and potentially fewer healthcare visits.
How similar studies have performed: Previous trials of maintenance strategies such as supervised exercise, home-based programs, and telephone follow-up have shown mixed but sometimes promising results, leaving overall evidence limited and heterogeneous.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 40 to 75 years. * Confirmed medical diagnosis of chronic obstructive pulmonary disease (COPD) of moderate to severe severity, based on clinical evaluation and pulmonary function testing. * Clinically stable for at least 4 weeks following the last severe exacerbation, as confirmed by the treating pulmonologist. * Referred to an outpatient pulmonary rehabilitation program due to persistent symptoms and a history of exacerbations, with moderate to severe dyspnea (Medical Research Council \[MRC\] dyspnea scale score \> 2), according to physician assessment. * Completed at least 6 out of 8 sessions of a standard 8-week initial pulmonary rehabilitation program. Exclusion Criteria: * Presence of medical contraindications to physical exercise, including unstable cardiovascular conditions (e.g., recent myocardial infarction, uncontrolled arrhythmias), severe musculoskeletal or neurological disorders, recent surgery, or acute medical conditions (e.g., recent stroke) that impair participation. * Severe cognitive impairment that limits the ability to understand instructions or participate actively in the program. * Unstable psychiatric disorders that may compromise adherence to or continuity with the exercise regimen. * Lack of availability or refusal to attend the scheduled sessions of the community-based exercise program. * Participation in another pulmonary rehabilitation program within the 6 months prior to study enrollment.
Where this trial is running
Lleida, Catalonia and 1 other locations
- Arnau de Vilanova University Hospital — Lleida, Catalonia, Spain (Recruiting)
- Arnau de Vilanova University Hospital — Lleida, Spain (Recruiting)
Study contacts
- Study coordinator: Jessica G MD, PhD, MD, PhD
- Email: jgonzalezgutierrez88@gmail.com
- Phone: 973702497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.