Effects of Expiratory Muscle Training Added to Pulmonary Rehabilitation in Patients With Bronchiectasis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIstanbul Demiroglu Bilim University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • pulmonary rehabilitation

    Other intervention

    Participants 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

    Device

    Expiratory 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

40 Participants
are divided into 2 treatment groups
Group A: pulmonary rehabilitationExperimental treatment 1 intervention
Group B: Pulmonary Rehabilitation plus Expiratory Muscle TrainingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks
3

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.

Time frame
Baseline and 8 weeks
4

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.

Time frame
Baseline and 8 weeks

Secondary outcomes

1

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).

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks
3

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.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Demiroglu Bilim University

Lead sponsor

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: