BronchiectasisNCT06175039
Telerehabilitation in Patients With Bronchiectasis
A study testing Telerehabilitation exercise program in people with Bronchiectasis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
It is to determine the effectiveness of pulmonary rehabilitation by telerehabilitation method in bronchiectasis patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (CGr). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Telerehabilitation exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 4 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and over
- Diagnosed with bronchiectasis by HRCT
- Stable clinical state at the time of admission without infection or exacerbation in the previous 3 weeks
- Know how to use technological devices
Who cannot join
- A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training
- Patients with systemic diseases other than bronchiectasis that also affect the lungs, such as systemic lupus erythematosus, infection, interstitial lung disease, lung cancer, heart and kidney failure, which will cause shortness of breath
- Having balance problems that prevent them from doing exercises
- Participation in a pulmonary rehabilitation program within the past 12 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri University
Istanbul, Uskudar, 34668
About this study
Official title: Investigation of the Efficiency of Pulmonary Rehabilitation With Telerehabilitation Method in Patients With Bronchiectasis
It is to determine the effectiveness of pulmonary rehabilitation by telerehabilitation method in bronchiectasis patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (CGr).
Read the detailed description
Patients diagnosed with bronchiectasis by HRCT by a chest diseases specialist and referred to pulmonary rehabilitation by determining the severity of bronchiectasis with the Modified Reiff Score and Bronchiectasis Severity Index Score will be included in the study.
The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (KGr). TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the KGr group, a pulmonary rehabilitation information brochure will be given to after the initial evaluation. They will be asked to do the exercises on the brochure. The exercise period will be 8 weeks for both groups. Standard medical treatments for both groups will continue.
- Conditions
- Bronchiectasis
- Being tested
- Telerehabilitation exercise program, Control program
- Keywords
- bronchiectasis, pulmonary rehabilitation, telerehabilitation
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation exercise programOther
TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone.
Control programOther
KGr will be a pulmonary rehabilitation information brochure will be given after the initial evaluation. They will be asked to do the exercises on the brochure.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Exercise Group | Experimental | Not described Receives: Other: Telerehabilitation exercise program |
| Control Group | Other | Not described Receives: Other: Control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The exercise capacity
The exercise capacity will be assessed by the incremental shuttle walking test.
Measured: Change from baseline incremental shuttle walking distance at 8 weeks
Secondary outcomes (8)
Forced vital capacity (FVC)
Forced vital capacity will be assessed by the spirometer. Pulmonary function test will performe by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
Measured: Change from baseline FVC at 8 weeks
Forced expiratory volume in one second (FEV1)
Forced expiratory volume in one second will be assessed by the spirometer. Pulmonary function test will performe by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
Measured: Change from baseline FEV1 at 8 weeks
Respiratory muscle strength
Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.The mouth pressure measurement was performed with the Cosmed Pony Fx. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.
Measured: Change from baseline respiratory muscle strength at 8 weeks
Peripheral muscle strength
Peripheral muscle strength will be assessed by the hand held dynamometer
Measured: Change from baseline peripheral muscle strength at 8 weeks
Perception of dyspnea
Perception of dyspnea will be evaluated by Modified Medical Research Council Dyspnea 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. "O" means no dyspnea perception, "4" means severe dyspnea perception.
Measured: Change from baseline dyspnea perception at 8 weeks
Saint George Respiratory Questionnaire (SGRQ) score
The quality of life will be assessed by the Saint George Respiratory Questionnaire.The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Measured: Change from baseline SGRQ score at 8 weeks
Modified Borg Scale
Exertion and rest define the level of dyspnea. It consists of ten items that describe the severity of dyspnea according to its degree. A minimum of 1 and a maximum of 10 points can be obtained. 1, no shortness of breath. 10, maximal shortness of breath.
Measured: Change from baseline Modified Borg Scale score at 8 weeks
Leicester Cough Questıonnaıre (LCQ)
The cough will be assessed by the Leicester Cough Questionnaire. It includes physical, psychological and social sub-parameters and each item is scored between 1-7. High scores indicate that the cough is less affected, while low scores indicate that the cough is more affected.
Measured: Change from baseline LCQ score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start15 May 2023
- Primary completion16 Mar 2024
- Study completion4 Jun 2024
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.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (KGr).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Pehlivan, Assoc.Prof.Dr., Principal investigator, AdvisorBusra Ocal, Master Degree Student, Study chair, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175039
- Sponsor's protocol ID
- BronsTeleReh-1
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficiency of Pulmonary Rehabilitation With Telerehabilitation Method in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT06175039
- Acronym / sponsor ID
- BronsTeleReh-1
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, pulmonary rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 18 Dec 2023 (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.
It is to determine the effectiveness of pulmonary rehabilitation by telerehabilitation method in bronchiectasis patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (CGr).
Detailed description
Patients diagnosed with bronchiectasis by HRCT by a chest diseases specialist and referred to pulmonary rehabilitation by determining the severity of bronchiectasis with the Modified Reiff Score and Bronchiectasis Severity Index Score will be included in the study.
The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (KGr). TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the KGr group, a pulmonary rehabilitation information brochure will be given to after the initial evaluation. They will be asked to do the exercises on the brochure. The exercise period will be 8 weeks for both groups. Standard medical treatments for both groups will continue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (KGr).
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Exercise Group | Experimental | Other: Telerehabilitation exercise program |
| Control Group | Other | Other: Control program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 and over
- Diagnosed with bronchiectasis by HRCT
- Stable clinical state at the time of admission without infection or exacerbation in the previous 3 weeks
- Know how to use technological devices
Key exclusion criteria (4 listed)
- A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training
- Patients with systemic diseases other than bronchiectasis that also affect the lungs, such as systemic lupus erythematosus, infection, interstitial lung disease, lung cancer, heart and kidney failure, which will cause shortness of breath
- Having balance problems that prevent them from doing exercises
- Participation in a pulmonary rehabilitation program within the past 12 months
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 |
|---|---|---|
| Telerehabilitation exercise programTRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone. | Other | Telerehabilitation Exercise Group |
| Control programKGr will be a pulmonary rehabilitation information brochure will be given after the initial evaluation. They will be asked to do the exercises on the brochure. | Other | Control Group |
Primary outcome
The exercise capacity
Time frame: Change from baseline incremental shuttle walking distance at 8 weeks
The exercise capacity will be assessed by the incremental shuttle walking test.
8 secondary outcomes
Forced vital capacity (FVC)
Time frame: Change from baseline FVC at 8 weeks
Forced expiratory volume in one second (FEV1)
Time frame: Change from baseline FEV1 at 8 weeks
Respiratory muscle strength
Time frame: Change from baseline respiratory muscle strength at 8 weeks
Peripheral muscle strength
Time frame: Change from baseline peripheral muscle strength at 8 weeks
Perception of dyspnea
Time frame: Change from baseline dyspnea perception at 8 weeks
Saint George Respiratory Questionnaire (SGRQ) score
Time frame: Change from baseline SGRQ score at 8 weeks
Modified Borg Scale
Time frame: Change from baseline Modified Borg Scale score at 8 weeks
Leicester Cough Questıonnaıre (LCQ)
Time frame: Change from baseline LCQ score at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Esra Pehlivan, Assoc.Prof.Dr. principal investigator
Advisor
Busra Ocal, Master Degree Student study chair
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation exercise program in people with Bronchiectasis, run by Saglik Bilimleri Universitesi 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 7 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The exercise capacity (time frame: Change from baseline incremental shuttle walking distance at 8 weeks). 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 7 Jun 2024.