Maintenance pulmonary rehabilitation program (PRP) in patients with chronic obstructive pulmonary disease who completed an initial PRP. Respiratory
Conditions
Interventions
Methods summary:
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 ass
Sponsors
Biomedical Research Institute of Lleida
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 40 to 75 years 2. Confirmed medical diagnosis of chronic obstructive pulmonary disease (COPD) of moderate to severe severity, based on clinical evaluation and pulmonary function testing 3. Clinically stable for at least 4 weeks following the last severe exacerbation, as confirmed by the treating pulmonologist 4. 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 5. Completed at least 6 out of 8 sessions of a standard 8-week initial pulmonary rehabilitation program
Exclusion criteria
Exclusion criteria: 1. 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 2. Severe cognitive impairment that limits the ability to understand instructions or participate actively in the program 3. Unstable psychiatric disorders that may compromise adherence to or continuity with the exercise regimen 4. Lack of availability or refusal to attend the scheduled sessions of the community-based exercise program 5. Participation in another pulmonary rehabilitation program within the 6 months before study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dyspnea will be measured using the Dyspnea-12 (D-12) questionnaire at month 12 post-baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence (% attendance): Treatment adherence will be measured as the percentage of attended supervised rehabilitation sessions out of the total prescribed, using study data from baseline to month 12 2. Disease-specific Health-related Quality of Life will be measured using the COPD Assessment Test (CAT total score) at baseline, month 3, 6, and 12 3. General Health-related Quality of Life will be measured using the EQ-5D-5L index and a visual analog scale (VAS) at baseline, month 3, 6, and 12 4. Exercise Capacity will be measured using the 6-minute walk test distance (meters) at baseline, month 3, 6, and 12 5. Respiratory Function (FEV1, FVC, DLCO, % predicted) will be measured using spirometry, with results expressed as % predicted based on international reference values at baseline and month 12 6. Direct Healthcare Costs will be calculated from the healthcare provider's perspective, based on hospitalizations, unscheduled visits, and medication use. Costs will be expressed in euros (€) for 2025, measured using hospital data, from baseline to month 12 7. Quality-adjusted Life Years (QALYs) will be estimated using EQ-5D-5L utility scores and area-under-the-curve methods from baseline to month 12 8. Cost-utility Ratio: Incremental cost-utility ratios (ICURs) will be calculated by dividing incremental costs (€) by incremental QALYs gained between intervention and control groups. Bootstrapping methods will be used to account for uncertainty from baseline to month 12 | — |
Countries
Spain
Contacts
Public ContactAnna Sánchez Cucó
Outcome results
None listed