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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
Functional capacity assessed by the six-minute walk test (6MWT)
Functional capacity will be measured using the six-minute walk test (6MWT), expressed as distance walked in meters.
Time frame: Change from baseline to 8 weeks (end of intervention)
Maximal inspiratory pressure (MIP)
Respiratory muscle strength assessed by maximal inspiratory pressure (MIP), expressed in cmH₂O.
Time frame: Change from baseline to 8, 12, and 24 weeks
Maximal expiratory pressure (MEP)
Respiratory muscle strength assessed by maximal expiratory pressure (MEP), expressed in cmH₂O.
Time frame: Change from baseline to 8, 12, and 24 weeks
Quadriceps muscle strength
Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons.
Time frame: Change from baseline to 8, 12, and 24 weeks
Five-times sit-to-stand test (5STS)
Functional lower limb performance assessed by the time required to complete five sit-to-stand repetitions, expressed in seconds.
Time frame: Change from baseline to 8, 12, and 24 weeks
One-minute sit-to-stand test (1-min STS)
Functional capacity assessed by the number of repetitions completed in one minute.
Time frame: Change from baseline to 8, 12, and 24 weeks
Dyspnea assessed by the modified Medical Research Council (mMRC) scale
Dyspnea severity measured using the mMRC scale (range 0-4, higher scores indicate worse dyspnea).
Time frame: Change from baseline to 8, 12, and 24 weeks
COPD Assessment Test (CAT)
Health status assessed using the CAT questionnaire (range 0-40, higher scores indicate worse health status).
Time frame: Change from baseline to 8, 12, and 24 weeks
Short Form-36 Health Survey (SF-36)
Health-related quality of life assessed using the SF-36 questionnaire across multiple domains.
Time frame: Change from baseline to 8, 12, and 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Psychological status assessed using the HADS questionnaire (range 0-21 per subscale, higher scores indicate worse symptoms).
Time frame: Change from baseline to 8, 12, and 24 weeks
Physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
Physical activity levels assessed using the IPAQ questionnaire.
Time frame: At 8 and 24 weeks
Adherence to pulmonary rehabilitation program
Adherence defined as the percentage of attended supervised sessions.
Time frame: During the 8-week intervention period
COPD exacerbations
Number of COPD exacerbations during follow-up.
Time frame: Up to 24 weeks
Emergency department visits and hospital admissions
Number of COPD-related emergency visits and hospital admissions.
Time frame: Up to 24 weeks
Adverse events
Incidence of adverse events, including fatigue, dyspnea, pain, dizziness, and falls.
Time frame: During the 8-week intervention and follow-up up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.