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

NCT07394712 | Recruiting DMC

• 1 other identifier: CEIC-3295
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Randomised Controlled Trial; COPD - Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation

Keywords

Pulmonary rehabilitation; chronic obstructive pulmonary disease (COPD); Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Dyspnea (Dyspnea-12 total score)

  Dyspnea will be assessed using the Dyspnea-12 (D-12) questionnaire. The D-12 is a validated self-administered tool that quantifies breathlessness across 12 descriptors (physical and affective). Each item is scored from 0 (none) to 3 (severe), yielding a total score from 0 to 36, with higher scores indicating greater severity. The primary outcome will be the D-12 total score at Month 12, compared between intervention and control groups.

  Month 12 post-baseline

Secondary Outcomes (8)

• Treatment Adherence (% attendance)

  From Baseline to Month 12

• Disease-specific Health-related Quality of Life (COPD Assessment Test, CAT total score)

  Baseline, Month 3, Month 6, Month 12

• General Health-related Quality of Life (EQ-5D-5L index and VAS score)

  Baseline, Month 3, Month 6, Month 12

• Exercise Capacity (6-minute walk test distance, meters)

  Baseline, Month 3, Month 6, Month 12

• Respiratory Function (FEV1, FVC, DLCO, % predicted)

  Baseline, Month 12

Study Arms (2)

Supervised multidimensional pulmonary rehabilitation maintenance program

EXPERIMENTAL

Participants assigned to the intervention group will engage in a supervised, multidimensional pulmonary rehabilitation maintenance program over a period of three months. This program will consist of two weekly sessions of supervised exercise and a total of six educational sessions, each lasting approximately 20 minutes, delivered twice per month. The educational sessions will address key topics such as the prevention and management of chronic obstructive pulmonary disease (COPD) exacerbations and the adoption of healthy lifestyle behaviors. All sessions will be conducted at a comprehensive healthcare center by a physiotherapist who serves as both the program facilitator and case manager. The aim of this intervention is to sustain the clinical benefits achieved during the initial 8-week pulmonary rehabilitation program and to promote long-term self-management and functional capacity.

Behavioral: Interdisciplinary intervention

Standard physical activity recommendations and unsupervised home exercise

NO INTERVENTION

The control group will receive general recommendations for physical activity and a table of exercises to be performed at home, as established in standard clinical practice. They will not receive supervised interventions, however, they will be followed during the 12 months of the study and evaluated at the same times and with the same variables as the intervention group (baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)).

Interventions

Interdisciplinary intervention BEHAVIORAL

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

Supervised multidimensional pulmonary rehabilitation maintenance program

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead

Study Sites (2)

Arnau de Vilanova University Hospital

Lleida, Catalonia, 25198, Spain

RECRUITING

Arnau de Vilanova University Hospital

Lleida, Spain

RECRUITING

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica G MD, PhD, MD, PhD

CONTACT

973702497; jgonzalezgutierrez88@gmail.com

Ferran Barbé, MD, PhD

CONTACT

973702959; febarbe.lleida.ics@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding: Role separation will allow for blinding of the outcome assessor and personnel involved in data analysis and interpretation of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: February 6, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)