Pulmonary Rehabilitation Frequency in COPD Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHospital Universitario Fundación Alcorcón
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Modified Medical Research Council (mMRC) dyspnoea scale ≥2
Ability to actively participate and perform physical exercise
Signed informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary Rehabilitation
BehavioralSupervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
Treatment groups
158 Participants
are divided into 2 treatment groupsGroup A: Pulmonary Rehabilitation 3 Days/WeekExperimental treatment 1 intervention
Group B: Pulmonary Rehabilitation 1 Day/WeekExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 weeks2
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 weeks3
Quadriceps muscle strength
Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons.
Time frame
Change from baseline to 8, 12, and 24 weeks4
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 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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