BronchiectasisNCT03561818
Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis
A study testing Hospital-based pulmonary rehabilitation and Home-based pulmonary rehabilitation in people with Bronchiectasis and Pulmonary Rehabilitation, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the home-based Pulmonary Rehabilitation with the hospital-based pulmonary rehabilitation in terms of pulmonary rehabilitation efficiency in patient with bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchiectasis, Pulmonary Rehabilitation, Lung Diseases
- What is being tested?
- Hospital-based pulmonary rehabilitation and Home-based pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2018to 30 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-70
- Patients signing informed consent form
- Bronchiectasis patients in the stable phase who were diagnosed with High-resolution computed tomography (HRCT).
Who cannot join
- Decompensated heart failure, uncontrolled hypertension (Systolic Blood Pressure> 200, Diastolic Blood Pressure> 110),
- Additional diseases that may prevent exercise,
- To be regularly exercising regularly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, 34200
Esra Pehlivan, PhD, fztesrakambur@yahoo.com
About this study
Official title: Comparison of Pulmonary Rehabilitation Efficiency in Home-based With Hospital-based Pulmonary Rehabilitation in Bronchiectasis
The investigators aimed to compare the home-based Pulmonary Rehabilitation with the hospital-based pulmonary rehabilitation in terms of pulmonary rehabilitation efficiency in patient with bronchiectasis.
Read the detailed description
While the benefits of pulmonary rehabilitation (PR) in cases of chronic obstructive pulmonary disease (COPD) have been well-documented, there have been only a limited number of studies investigating the efficacy of PR in patients with bronchiectasis. Some of these studies have reported positive effects of PR also in bronchiectasis patients, but have underlined the need for additional studies including larger patient groups to define PR indications, and to ensure that exercise protocols are specific for this patient group. There are many PR organizational types, such as hospital-based, telephone-mentoring with home-based or tele monitorization programs. Hospital-based supervised programs are time-consuming and costly practices. For this reason, there is a need for further studies on the effectiveness and benefits of unsupervised programs. In this study, we will compare unsupervised home-based PR and supervised hospital-based PR in terms of pulmonary rehabilitation effectiveness.
The pulmonary function tests, dyspnea perception, quality of life and exercise capacity assessments will performed before and after pulmonary rehabilitation.
- Being tested
- Hospital-based pulmonary rehabilitation, Home-based pulmonary rehabilitation
- Medical subject headings
- Bronchiectasis, Lung Diseases, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-based pulmonary rehabilitationOther
The patients who undergo two days pulmonary rehabilitation under supervision in our clinic and three days a week at home during two months will taken as hospital group. The exercises include breathing exercises, treadmill (15sc), cycle training (15sc), arm ergometer training (15sc), peripheral muscle training and stretching exercises with free weights.
Home-based pulmonary rehabilitationOther
The patients who follow a home-based pulmonary rehabilitation program for two months comprising breathing exercises, training in chest hygiene techniques, peripheral muscle strengthening training and self-walking for 5 days in a week for two months. An exercise follow-up form will give to the patients to record their daily exercises. A similar form will fill by physiotherapist once a week during phone call.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based group | Experimental | 2 months hospital-based pulmonary rehabilitation program Receives: Other: Hospital-based pulmonary rehabilitation |
| Home-based group | Experimental | 2 months home-based pulmonary rehabilitation program Receives: Other: Home-based pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline the 6-minute walking distance at two months.
Measured: Two months
Changes from baseline the modified Medical Research Council (mMRC) scale at two months.
Dyspnea perceptions during daily life activities will assess according to the modified Medical Research Council (mMRC) scale. The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Measured: Two months
Secondary outcomes (3)
Changes from baseline the forced expiratory volume in one second at two months.
The Pulmonary Function Test conducted using a Sensor Medics model 2400 device (Yorba Linda, CA, USA), in line with American Thoracic Society (ATS) guidelines.
Measured: Two months
Changes from baseline the peripheral muscle strength at two months.
Peripheral Muscle Strength will measure using a digital dynamometer(J-Tech Commander muscle testing device), with three measurements make in total of the quadriceps femoris, tibialis anterior and iliopsoas muscles.
Measured: Two months
Changes from baseline the Quality of Life at two months.
St. George Respiratory Questionnaire
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start19 Jun 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561818
- Sponsor's protocol ID
- PR_bronchiectasis
- Status last verified
- Apr 2025
- First submitted
- 14 May 2018
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulmonary Rehabilitation Efficiency in Home-based With Hospital-based Pulmonary Rehabilitation in Bronchiectasis
- ClinicalTrials.gov ID
- NCT03561818
- Acronym / sponsor ID
- PR_bronchiectasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to compare the home-based Pulmonary Rehabilitation with the hospital-based pulmonary rehabilitation in terms of pulmonary rehabilitation efficiency in patient with bronchiectasis.
Detailed description
While the benefits of pulmonary rehabilitation (PR) in cases of chronic obstructive pulmonary disease (COPD) have been well-documented, there have been only a limited number of studies investigating the efficacy of PR in patients with bronchiectasis. Some of these studies have reported positive effects of PR also in bronchiectasis patients, but have underlined the need for additional studies including larger patient groups to define PR indications, and to ensure that exercise protocols are specific for this patient group. There are many PR organizational types, such as hospital-based, telephone-mentoring with home-based or tele monitorization programs. Hospital-based supervised programs are time-consuming and costly practices. For this reason, there is a need for further studies on the effectiveness and benefits of unsupervised programs. In this study, we will compare unsupervised home-based PR and supervised hospital-based PR in terms of pulmonary rehabilitation effectiveness.
The pulmonary function tests, dyspnea perception, quality of life and exercise capacity assessments will performed before and after pulmonary rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-based group | Experimental | Other: Hospital-based pulmonary rehabilitation2 months hospital-based pulmonary rehabilitation program |
| Home-based group | Experimental | Other: Home-based pulmonary rehabilitation2 months home-based pulmonary rehabilitation program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18-70
- Patients signing informed consent form
- Bronchiectasis patients in the stable phase who were diagnosed with High-resolution computed tomography (HRCT).
Key exclusion criteria (3 listed)
- Decompensated heart failure, uncontrolled hypertension (Systolic Blood Pressure> 200, Diastolic Blood Pressure> 110),
- Additional diseases that may prevent exercise,
- To be regularly exercising regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital-based pulmonary rehabilitationThe patients who undergo two days pulmonary rehabilitation under supervision in our clinic and three days a week at home during two months will taken as hospital group. The exercises include breathing exercises, treadmill (15sc), cycle training (15sc), arm ergometer training (15sc), peripheral muscle training and stretching exercises with free weights. | Other | Hospital-based group |
| Home-based pulmonary rehabilitationThe patients who follow a home-based pulmonary rehabilitation program for two months comprising breathing exercises, training in chest hygiene techniques, peripheral muscle strengthening training and self-walking for 5 days in a week for two months. An exercise follow-up form will give to the patients to record their daily exercises. A similar form will fill by physiotherapist once a week during phone call. | Other | Home-based group |
Primary outcome
Changes from baseline the 6-minute walking distance at two months.
Time frame: Two months
Changes from baseline the modified Medical Research Council (mMRC) scale at two months.
Time frame: Two months
Dyspnea perceptions during daily life activities will assess according to the modified Medical Research Council (mMRC) scale. The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "0" means no dyspnea perception, "4" means severe dyspnea perception.
3 secondary outcomes
Changes from baseline the forced expiratory volume in one second at two months.
Time frame: Two months
Changes from baseline the peripheral muscle strength at two months.
Time frame: Two months
Changes from baseline the Quality of Life at two months.
Time frame: Two months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: Undecided
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital-based pulmonary rehabilitation and Home-based pulmonary rehabilitation in people with Bronchiectasis and Pulmonary Rehabilitation, run by Istanbul Medipol University Hospital 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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 Esra Pehlivan, PhD (+905058527913, fztesrakambur@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline the 6-minute walking distance at two months. (time frame: Two months). The study lists 2 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 1 May 2025.