NCT07394712Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
Introduction: Pulmonary rehabilitation programs (PRPs) are known to reduce symptoms such as dyspnea and fatigue, while improving functional capacity and quality of life in individuals with chronic obstructive pulmonary disease (COPD). However, the benefits of an initial pulmonary rehabilitation program (PRP) tend to diminish rapidly over time, prompting the development of strategies to maintain these effects. Such strategies include supervised exercise programs, telephone follow-ups, and home-based exercise regimens. Nevertheless, the optimal maintenance strategy remains uncertain. Objectives: The primary objective is to evaluate the impact of a supervised, multidimensional maintenance PRP on symptoms and quality of life in individuals with COPD. Additionally, the study aims to compare exercise capacity, healthcare resource utilization, economic benefits, and participant perceptions between the intervention and control groups. Methodology: A 12-month randomized controlled trial (RCT) with two parallel groups will be conducted in adults with COPD who have completed an initial 8-week PRP. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group. The intervention group will undergo a maintenance PRP consisting of two weekly supervised exercise sessions and monthly educational sessions on COPD in a comprehensive health center over a 3-month period. The control group will receive standard clinical care recommendations regarding physical activity. Clinical evaluations will be conducted at four time points throughout the study: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3). Full pulmonary function tests and anthropometric assessments will be performed at T0 and T3. Other variables, including symptom burden, quality of life, functional capacity, mental health, physical activity, sleep-wake pattern, and healthcare utilization, will be systematically collected at all four time points.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 1 Oct 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Diseases
- COPD
- NCT number
- NCT07394712
What you commit to
- Study type: Interventional
- Planned participants: 86
- From 1 Oct 2025 to the primary completion date, Oct 2027
- 1 site in 1 country
- 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.
Prior treatment
- Participation in another pulmonary rehabilitation program within the 6 months prior to study enrollment.
Other illness
- 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.
Other
- Lack of availability or refusal to attend the scheduled sessions of the community-based exercise program.
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arnau de Vilanova University Hospital Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.