Effects of Expiratory Muscle Training Added to Pulmonary Rehabilitation on Pulmonary Function, Respiratory Muscle Strength, and Functional Capacity in Patients With Bronchiectasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Functional capacity
Study Overview
Brief Summary
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.
Detailed Description
his study will be conducted as a randomized controlled, single-blind, parallel-group trial. Ethical approval has been applied for from the University of Health Sciences Hamidiye Non-Drug and Non-Medical Device Interventional Research Ethics Committee, and the evaluation process is currently ongoing. Upon receipt of the ethical approval, the approval document will be submitted to the Scientific Research Projects (BAP) Commission by the principal investigator.
Following ethical approval, individuals aged 18-70 years with a clinical diagnosis of stable non-cystic fibrosis bronchiectasis who are being followed at the Pulmonary Rehabilitation Unit of the University of Health Sciences Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital will be eligible for inclusion. Patients who have experienced an acute exacerbation within the last three months, have severe cardiac, neurological, or orthopedic diseases, demonstrate lack of cooperation, or have communication difficulties will be excluded from the study.
Eligible participants will be randomly assigned to one of two groups using a simple randomization method: (1) a control group receiving a standard pulmonary rehabilitation program, and (2) an intervention group receiving standard pulmonary rehabilitation combined with expiratory muscle training.
The standard pulmonary rehabilitation program will be conducted on an outpatient basis for eight weeks, three days per week, under direct supervision. Prior to enrollment, all participants will undergo cardiology consultation, lower extremity venous Doppler ultrasonography for deep vein thrombosis screening, chest radiography, electrocardiography, pulmonary function testing, and routine laboratory assessments. Baseline evaluations will include symptom assessment, physical examination, oxygen saturation levels, current medical treatments, comorbidities, disease duration, oxygen therapy requirements, use of respiratory support devices, smoking history, and anthropometric measurements (height, weight, body mass index, and fat-free mass). Pulmonary function tests (FVC, FEV₁, and diffusion capacity), nutritional assessment, medication review and education, disease-related patient and caregiver education, and functional exercise capacity assessment using field tests such as the 6-minute walk test will be performed. All assessments will be repeated at the end of the rehabilitation program. Written informed consent will be obtained from all participants prior to inclusion.
During the eight-week rehabilitation period, participants will attend supervised sessions at the hospital three days per week and will be encouraged to continue prescribed exercises at home on non-supervised days using an exercise diary. Oxygen saturation and heart rate will be continuously monitored using pulse oximetry during sessions, and blood pressure measurements will be taken before and after exercise. Perceived dyspnea and fatigue levels will be assessed using the Borg scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Ability to understand and comply with the study procedures
- •Provided written informed consent
Exclusion Criteria
- •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
- •Any medical condition contraindicating participation in pulmonary rehabilitation or expiratory muscle training
Outcomes
Primary Outcomes
Functional capacity
Time Frame: Baseline and 8 weeks
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)
Time Frame: Baseline and 8 weeks
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)
Time Frame: Baseline and 8 weeks
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)
Time Frame: Baseline and 8 weeks
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.
Forced Expiratory Volume in 1 Second (FEV₁)
Time Frame: Baseline and 8 weeks
Forced Expiratory Volume in 1 second (FEV₁) will be measured using a portable spirometer calibrated according to ATS/ERS standards. The best result from at least three attempts will be recorded.
FEV₁/FVC Ratio
Time Frame: Baseline and 8 weeks
FEV₁/FVC ratio will be calculated from spirometry results. The best result from at least three attempts will be recorded.
Cough Strength (Peak Cough Flow, PCF)
Time Frame: Baseline and 8 weeks
Peak Cough Flow (PCF) will be measured using a peak flow meter.
Secondary Outcomes
- Fatigue Severity(Baseline and 8 weeks)
- Dyspnea Severity(Baseline and 8 weeks)
- Health-Related Quality of Life(Baseline and 8 weeks)
Investigators
Reyhan Kaygusuz
Assistant Professor
Istanbul Demiroglu Bilim University
