Actively Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
Led by Institut de Recerca Biomèdica de Lleida · Updated on 2026-02-06
86
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 to 75 years
- Medical diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD)
- Clinically stable for at least 4 weeks after the last severe COPD exacerbation
- Referred to outpatient pulmonary rehabilitation due to persistent symptoms and moderate to severe dyspnea (MRC score > 2)
- Completed at least 6 out of 8 sessions of a standard 8-week initial pulmonary rehabilitation program
You will not qualify if you...
- Medical contraindications to physical exercise, including unstable cardiovascular conditions, severe musculoskeletal or neurological disorders, recent surgery, or acute medical conditions
- Severe cognitive impairment limiting understanding or participation
- Unstable psychiatric disorders compromising adherence
- Unavailability or refusal to attend scheduled community-based exercise sessions
- Participation in another pulmonary rehabilitation program within 6 months before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Arnau de Vilanova University Hospital
Lleida, Catalonia, Spain, 25198
Actively Recruiting
2
Arnau de Vilanova University Hospital
Lleida, Spain
Actively Recruiting
Research Team
J
Jessica G MD, PhD, MD, PhD
CONTACT
F
Ferran Barbé, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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