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Bronchiectasis AdultNCT07317531

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

A study testing pulmonary rehabilitation and Expiratory muscle training in people with Bronchiectasis Adult and Expiratory Muscle Training, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
pulmonary rehabilitation and Expiratory muscle training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

reyhan kaygusuz benli, Assist Prof contact

+905533057467

reyhan.kaygusuz@demiroglu.bilim.edu.tr

Turkey (Türkiye)1 site
  • Demiroglu Bilim University, Department of Physiotherapy and Rehabilitation

    Istanbul

    reyhan kaygusuz benli, Assist Prof, +905533057467

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Expiratory Muscle Training Added to Pulmonary Rehabilitation on Pulmonary Function, Respiratory Muscle Strength, and Functional Capacity in Patients With Bronchiectasis

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.

Read the 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.

Exercise training will be individualized based on baseline exercise capacity assessments. Each session will include upper and lower extremity strengthening exercises, stretching, relaxation exercises, aerobic training (treadmill walking and cycling), breathing exercises, and relaxation techniques. Aerobic exercise will be performed at 60-80% of the target heart rate, consisting of a 10-minute warm-up, 30 minutes of aerobic exercise, and a 10-minute cool-down period. Resistance training will be performed at 50% of one-repetition maximum, with one set of 10 repetitions per session, targeting both upper and lower extremity muscle groups.

In addition to pulmonary rehabilitation, participants in the intervention group will perform expiratory muscle training using an adjustable PowerBreathe EX1 expiratory muscle training device. The initial training resistance will be set at 30-40% of maximal expiratory pressure (MEP) and will be progressively increased by 5-10% on a weekly basis. Training will be performed three days per week, consisting of two sets per day, with each set including 10-15 repetitions.

Outcome measures will be assessed at baseline and after completion of the intervention period by an experienced physiotherapist using standardized procedures in accordance with international guidelines. Pulmonary function will be assessed using spirometry to measure forced vital capacity (FVC), forced expiratory volume in one second (FEV₁), and the FEV₁/FVC ratio, following American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. Peak cough flow will be measured in liters per minute using a peak flow meter. Respiratory muscle strength will be evaluated by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a digital manometer in accordance with ATS/ERS guidelines. Functional exercise capacity will be assessed using the 6-minute walk test performed on a 30-meter corridor according to ATS protocol, with continuous monitoring of oxygen saturation, heart rate, and perceived exertion using the Borg scale. Dyspnea severity will be evaluated using the modified Medical Research Council (mMRC) dyspnea scale. Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). Fatigue severity will be evaluated using the Fatigue Severity Scale.

Statistical analysis will be performed using SPSS software. Normally distributed data will be analyzed using independent and paired t-tests, while non-normally distributed data will be analyzed using the Mann-Whitney U test and Wilcoxon signed-rank test. Statistical significance will be set at p < 0.05. Sample size was determined using power analysis with G*Power version 3.1.9.7. Based on an effect size of 0.25, a significance level of 0.05, and a power of 0.80, a total sample size of 34 participants was calculated. Considering a potential dropout rate of 15%, the total sample size was increased to 40 participants.

Being tested
pulmonary rehabilitation, Expiratory muscle training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07317531
Study groupRoleWhat they receive
pulmonary rehabilitationExperimentalParticipants will receive a standard pulmonary rehabilitation program consisting of aerobic exercise, resistance training, breathing exercises, and patient education.
Receives: Other: pulmonary rehabilitation
Pulmonary Rehabilitation plus Expiratory Muscle TrainingExperimentalParticipants will receive a standard pulmonary rehabilitation program combined with structured expiratory muscle training.
Receives: Other: pulmonary rehabilitation; Device: Expiratory muscle training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 8 weeks

  5. 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.

    Measured: Baseline and 8 weeks

  6. FEV₁/FVC Ratio

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

    Measured: Baseline and 8 weeks

  7. Cough Strength (Peak Cough Flow, PCF)

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

    Measured: Baseline and 8 weeks

Secondary outcomes (3)
  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).

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07317531
Sponsor's protocol ID
bronchiectasis and EMT
Status last verified
Dec 2025
First submitted
18 Dec 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing pulmonary rehabilitation and Expiratory muscle training in people with Bronchiectasis Adult and Expiratory Muscle Training, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact reyhan kaygusuz benli, Assist Prof (+905533057467, reyhan.kaygusuz@demiroglu.bilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional capacity (time frame: Baseline and 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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