RecruitingNot ApplicableNCT07394712

Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.


Sponsor

Institut de Recerca Biomèdica de Lleida

Enrollment

86 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial (the NAPOLEON Project) is testing a comprehensive long-term maintenance pulmonary rehabilitation program for people with moderate to severe COPD (chronic obstructive pulmonary disease) in the Lleida region of Spain. The goal is to see whether ongoing structured exercise and education after initial rehab keeps patients healthier and reduces hospital admissions. **You may be eligible if...** - You are 40 to 75 years old with a confirmed diagnosis of moderate to severe COPD - Your condition has been clinically stable for at least 4 weeks - You have significant breathlessness on activity (MRC dyspnea scale score above 2) - You have already completed at least 6 of the 8 sessions in a standard initial pulmonary rehabilitation program **You may NOT be eligible if...** - You have medical conditions that prevent you from safely exercising (e.g., unstable angina, recent fractures) - Your COPD has not been stable recently - You are unable to attend the outpatient rehabilitation sessions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALInterdisciplinary 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

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NCT07394712