About this trial
This randomized, single-blind, parallel-group controlled trial aims to investigate the effects of expiratory muscle training added to standard pulmonary rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, dyspnea perception, and quality of life in patients with non-cystic fibrosis bronchiectasis. Eligible patients aged 18-70 years with stable disease will be randomly assigned to either a pulmonary rehabilitation-only group or a pulmonary rehabilitation combined with expiratory muscle training group. Outcomes will be assessed at baseline and after completion of the intervention period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years
Clinical diagnosis of non-cystic fibrosis bronchiectasis
Stable disease status
Follow-up at the Pulmonary Rehabilitation Unit of University of Health Sciences Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital
Disqualifiers
Acute exacerbation within the last 3 months
Diagnosis of cystic fibrosis-related bronchiectasis
Presence of severe cardiac, neurological, or orthopedic diseases that may interfere with exercise training
Cognitive impairment, lack of cooperation, or communication difficulties
Trial design
Parallel
Treatments tested in this trial
pulmonary rehabilitation
Other interventionParticipants will undergo a standard pulmonary rehabilitation program including supervised aerobic exercise, resistance training, breathing exercises, and patient education. The program will be conducted three times per week over the intervention period in accordance with current pulmonary rehabilitation guidelines.
Expiratory muscle training
DeviceExpiratory muscle training will be performed using an adjustable PowerBreathe EX1 expiratory muscle training device. The initial training load will be set at 30-40% of the participant's maximal expiratory pressure (MEP) and will be progressively increased by 5-10% on a weekly basis. Training sessions will be conducted three days per week, consisting of two sets per day, with each set including 10-15 repetitions.
Treatment groups
Trial outcomes
Primary outcomes
Functional capacity
Functional capacity will be evaluated using the 6-minute walk test (6MWT) performed on a 30-meter corridor in accordance with ATS guidelines. Total walking distance will be recorded as the primary outcome of the test.
Maximum Inspiratory Pressure (MIP)
Respiratory muscle strength will be assessed using maximum inspiratory pressure (MIP), measured with a portable mouth pressure device according to standard guidelines. Higher values indicate better inspiratory muscle function.
Maximum Expiratory Pressure (MEP)
Respiratory muscle strength will be assessed using maximum expiratory pressure (MEP), measured with a portable mouth pressure device according to standard guidelines. Higher values indicate better expiratory muscle function.
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) will be measured using a portable spirometer calibrated according to American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. The best result from at least three attempts will be recorded.
Secondary outcomes
Dyspnea Severity
Dyspnea severity will be evaluated using the modified Medical Research Council (mMRC) dyspnea scale, ranging from 0 (no dyspnea) to 4 (severe dyspnea).
Health-Related Quality of Life
Quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ), including symptom, activity, and impact domains. Higher scores indicate worse health status.Scores for each domain and the total score range from 0 to 100, with higher scores indicating poorer health-related quality of life.
Fatigue Severity
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a validated self-report questionnaire evaluating the impact of fatigue on daily functioning.The scale consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity.
Sponsors and contacts
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Istanbul Demiroglu Bilim University
Lead sponsor
Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
Collaborator
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