RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

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