COPD, COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, Exercise training, Supervised Exercise, Home-based Rehabilitation, Pulmonary Rehabilitation
Brief summary
Chronic obstructive pulmonary disease (COPD) is a common condition that can cause breathlessness and reduced physical capacity. Pulmonary rehabilitation (PR) is an effective treatment, but traditional programs often require patients to attend sessions several times per week, which may limit participation. This study aims to compare the effectiveness of two supervised pulmonary rehabilitation programs: one performed 3 days per week and another performed 1 day per week, both over an 8-week period and including additional home-based exercises. The main objective is to determine whether the lower-frequency program is not inferior to the higher-frequency program in improving functional capacity, measured by the six-minute walk test. Secondary outcomes include dyspnea, quality of life, muscle strength, physical activity, adherence, exacerbations, and safety. The results of this study may help optimize pulmonary rehabilitation programs and improve accessibility for patients with COPD.
Detailed description
This is a randomized, parallel-group clinical trial designed to evaluate the non-inferiority of a supervised pulmonary rehabilitation (PR) program performed once weekly compared with a program performed three times weekly in patients with stable chronic obstructive pulmonary disease (COPD). Participants will be recruited from a tertiary care hospital and randomly assigned to one of two intervention groups: (1) supervised PR three days per week or (2) supervised PR one day per week. Both interventions will be conducted over 8 weeks and will include structured exercise training and educational components, complemented by a home-based program. The primary outcome is functional capacity assessed by the six-minute walk test. Secondary outcomes include dyspnea, health-related quality of life, peripheral muscle strength, physical activity levels, adherence to the intervention, incidence of exacerbations, and safety. Statistical analyses will be conducted according to both intention-to-treat and per-protocol principles. A non-inferiority framework will be applied, and appropriate mixed-effects models will be used to assess differences between groups over time.
Interventions
BEHAVIORALPulmonary Rehabilitation
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
Sponsors
Hospital Universitario Fundación Alcorcón
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, participants and care providers cannot be blinded. Outcome assessors are blinded to group allocation. Baseline and post-intervention evaluations are conducted by different assessors. Personnel performing functional tests, muscle strength assessments, and administering clinical scales remain unaware of treatment allocation.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
IInclusion criteria * Diagnosis of COPD confirmed by spirometry (FEV₁/FVC \<0.70) * Modified Medical Research Council (mMRC) dyspnoea scale ≥2 * Ability to actively participate and perform physical exercise * Signed informed consent
Exclusion criteria
* Unstable cardiac or musculoskeletal comorbidity contraindicating or limiting exercise * Moderate to severe cognitive impairment or inability to understand instructions * Recent participation (\<6 months) in a complete pulmonary rehabilitation programme * Inability to attend the centre 1-3 days/week according to group allocation * Current participation in any structured pulmonary rehabilitation programme or supervised rehabilitation intervention in another centre. * Active oncological treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity assessed by the six-minute walk test (6MWT) | Change from baseline to 8 weeks (end of intervention) | Functional capacity will be measured using the six-minute walk test (6MWT), expressed as distance walked in meters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal inspiratory pressure (MIP) | Change from baseline to 8, 12, and 24 weeks | Respiratory muscle strength assessed by maximal inspiratory pressure (MIP), expressed in cmH₂O. |
| Maximal expiratory pressure (MEP) | Change from baseline to 8, 12, and 24 weeks | Respiratory muscle strength assessed by maximal expiratory pressure (MEP), expressed in cmH₂O. |
| Quadriceps muscle strength | Change from baseline to 8, 12, and 24 weeks | Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons. |
| Five-times sit-to-stand test (5STS) | Change from baseline to 8, 12, and 24 weeks | Functional lower limb performance assessed by the time required to complete five sit-to-stand repetitions, expressed in seconds. |
| One-minute sit-to-stand test (1-min STS) | Change from baseline to 8, 12, and 24 weeks | Functional capacity assessed by the number of repetitions completed in one minute. |
| Dyspnea assessed by the modified Medical Research Council (mMRC) scale | Change from baseline to 8, 12, and 24 weeks | Dyspnea severity measured using the mMRC scale (range 0-4, higher scores indicate worse dyspnea). |
| COPD Assessment Test (CAT) | Change from baseline to 8, 12, and 24 weeks | Health status assessed using the CAT questionnaire (range 0-40, higher scores indicate worse health status). |
| Short Form-36 Health Survey (SF-36) | Change from baseline to 8, 12, and 24 weeks | Health-related quality of life assessed using the SF-36 questionnaire across multiple domains. |
| Hospital Anxiety and Depression Scale (HADS) | Change from baseline to 8, 12, and 24 weeks | Psychological status assessed using the HADS questionnaire (range 0-21 per subscale, higher scores indicate worse symptoms). |
| Physical activity assessed by the International Physical Activity Questionnaire (IPAQ) | At 8 and 24 weeks | Physical activity levels assessed using the IPAQ questionnaire. |
| Adherence to pulmonary rehabilitation program | During the 8-week intervention period | Adherence defined as the percentage of attended supervised sessions. |
| COPD exacerbations | Up to 24 weeks | Number of COPD exacerbations during follow-up. |
| Emergency department visits and hospital admissions | Up to 24 weeks | Number of COPD-related emergency visits and hospital admissions. |
| Adverse events | During the 8-week intervention and follow-up up to 24 weeks | Incidence of adverse events, including fatigue, dyspnea, pain, dizziness, and falls. |
Outcome results
None listed