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Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
Sponsor: Institut de Recerca Biomèdica de Lleida
Summary
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.
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2025-10-01
Completion Date
2026-10
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
Interdisciplinary intervention
This intervention integrates a structured, interdisciplinary educational and physical activity approach specifically designed for individuals with COPD who have completed a standard pulmonary rehabilitation program. The program is distinguished by its incorporation of six monthly educational sessions addressing key lifestyle-related topics, including sleep hygiene, nutrition based on the Mediterranean diet, smoking cessation, alcohol reduction, and clinical self-management. In parallel, participants engage in twice-weekly exercise sessions tailored to their individual capacity, combining aerobic, strength, and functional training. Exercise intensity is prescribed based on initial functional assessments, at 50-80% of the average speed achieved in the six-minute walk test or the workload reached in an incremental cycle ergometer test. All sessions are supervised by physiotherapists and emphasize patient empowerment, behavioral change, and long-term disease management
Locations (2)
Arnau de Vilanova University Hospital
Lleida, Catalonia, Spain
Arnau de Vilanova University Hospital
Lleida, Spain