NCT07317531

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

December 18, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 18, 2025

Last Update Submit

January 2, 2026

Conditions

Bronchiectasis AdultExpiratory Muscle TrainingPulmonary RehabilitationLung Function TestsFunctional CapacityRespiratory Muscle Strength

Outcome Measures

Primary Outcomes (7)

  • 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.

    Baseline and 8 weeks

  • 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.

    Baseline and 8 weeks

  • 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.

    Baseline and 8 weeks

  • 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.

    Baseline and 8 weeks

  • Forced Expiratory Volume in 1 Second (FEV₁)

    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.

    Baseline and 8 weeks

  • FEV₁/FVC Ratio

    FEV₁/FVC ratio will be calculated from spirometry results. The best result from at least three attempts will be recorded.

    Baseline and 8 weeks

  • Cough Strength (Peak Cough Flow, PCF)

    Peak Cough Flow (PCF) will be measured using a peak flow meter.

    Baseline and 8 weeks

Secondary Outcomes (3)

  • Dyspnea Severity

    Baseline and 8 weeks

  • Health-Related Quality of Life

    Baseline and 8 weeks

  • Fatigue Severity

    Baseline and 8 weeks

Study Arms (2)

pulmonary rehabilitation

EXPERIMENTAL

Participants will receive a standard pulmonary rehabilitation program consisting of aerobic exercise, resistance training, breathing exercises, and patient education.

Other: pulmonary rehabilitation

Pulmonary Rehabilitation plus Expiratory Muscle Training

EXPERIMENTAL

Participants will receive a standard pulmonary rehabilitation program combined with structured expiratory muscle training.

Other: pulmonary rehabilitationDevice: Expiratory muscle training

Interventions

pulmonary rehabilitationOTHER

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.

Pulmonary Rehabilitation plus Expiratory Muscle Trainingpulmonary rehabilitation
Expiratory muscle trainingDEVICE

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.

Pulmonary Rehabilitation plus Expiratory Muscle Training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • reyhan kaygusuz benli, Asst Prof

    Istanbul Demiroglu Bilim University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

reyhan kaygusuz benli, Assist Prof

CONTACT

+905533057467reyhan.kaygusuz@demiroglu.bilim.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is designed as a prospective, randomized controlled, parallel-group clinical trial. Eligible patients with bronchiectasis will be randomly assigned to either a pulmonary rehabilitation program alone (control group) or pulmonary rehabilitation combined with expiratory muscle training (intervention group). Both groups will receive the same standard pulmonary rehabilitation protocol, while the intervention group will additionally perform structured expiratory muscle training. Outcomes will be assessed at baseline and after completion of the intervention period to compare the effects of the two treatment approaches.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 5, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

TU(1)