Health Haven: Comprehensive maintenance program for COPD in Lleida (NAPOLEON)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arnau de Vilanova University Hospital
  Lleida, Catalonia, Spain Recruiting
• Arnau de Vilanova University Hospital
  Lleida, Lleida, Spain Recruiting

Study contacts

• Study coordinator: Jessica G MD, PhD, MD, PhD
• Email: jgonzalezgutierrez88@gmail.com
• Phone: 973702497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.