BronchiectasisNCT05084547
Comparison of Upper Extremity Exercise Capacity and ADL Between Subjects With Bronchiectasis and Healthy Controls
An observational study of Bronchiectasis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Bronchiectasis is a chronic lung disease characterized by permanent dilatation and destruction, resulting from the destruction of elastic tissue and muscular components in the bronchial walls, due to infection or inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2020to 22 Dec 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with bronchiectasis and healthy controls
Who may be able to join
- Diagnosed with bronchiectasis and being clinically stable,
- Being 18 years old or older,
- Being able and willing to complete the informed consent process.
Who cannot join
- Individuals with bronchiectasis whose clinical condition is unstable,
- Individuals with bronchiectasis who have severe neuromuscular, musculoskeletal, and rheumatological problems,
- Being unable to cooperate,
- Not being willing to participate in the study
- The healthy controls will be composed of individuals who volunteered for the study without any known disease. Healthy individuals who did not volunteer to participate in the study will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Upper Extremity Exercise Capacity and Activities of Daily Living Between Subjects With Bronchiectasis and Healthy Controls
Bronchiectasis is a chronic lung disease characterized by permanent dilatation and destruction, resulting from the destruction of elastic tissue and muscular components in the bronchial walls, due to infection or inflammation. The exercise tolerance, physical activity level, respiratory and peripheral muscle strength of patients with bronchiectasis are lower than those of healthy individuals. The decrease in exercise tolerance occurs while performing upper extremity activities as well as lower extremity tasks. Many studies have reported that upper extremity exercise capacity is reduced in chronic obstructive pulmonary disease (COPD), a disease similar to bronchiectasis, and that patients often experience significant dyspnea and fatigue during upper extremity tasks that are important for daily life. The mechanisms causing this situation may be neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory muscles) (thoracoabdominal asynchrony) and changes in lung volume in activities involving the upper extremities. The disturbances in ventilatory mechanics in patients with COPD cause upper extremity exercise to be terminated at low workloads compared to healthy individuals. Upper extremity exercise has been defined as part of pulmonary rehabilitation. The determination of upper extremity exercise capacity may play a predictive role in maintaining and improving upper extremity and daily life activity level in patients with chronic lung disease.
Six-minute Pegboard and Ring test (6PBRT) is used to evaluate extremity exercise capacity and upper extremity function and endurance. The 6PBRT score and upper extremity daily living activities show a clear relationship in patients with COPD, and it can be used to determine and improve the performance of daily living activities in pulmonary rehabilitation programs. Glittre Activities of Daily Living (Glittre ADL test) covers activities that are necessary for daily living and commonly used activities. The Glittre ADL test produces similar cardiorespiratory responses when compared with the six-minute walk test. In this study, unsupported upper extremity exercise capacity and upper extremity function/endurance and the performance of daily living activities will be compared in participants with bronchiectasis and compared with healthy individuals.
- Conditions
- Bronchiectasis
- Being tested
- No intervention
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Case | Subjects with Bronchiectasis Receives: Other: No intervention | |
| Control | Healthy Controls Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test - Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Measured: 1st day
Pulmonary function test - Forced expiratory volume in one second
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Measured: 1st day
Pulmonary function test - Forced expiratory volume in one second/Forced vital capacity
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/Forced vital capacity in one second will be recorded.
Measured: 1st day
Pulmonary function test - Peak expiratory flow
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Measured: 1st day
Pulmonary function test - Forced mid-expiratory flow (FEF25-75)
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Measured: 1st day
Glittre Activities of Daily Living Test
The test covers activities that are necessary for daily living and commonly used activities that are known to be difficult for patients with COPD.
Measured: 1st day
Unsupported upper extremity exercise capacity
Upper extremity exercise capacity will be evaluated using 6PBRT. During the test, the patient is asked to sit in front of a pegboard and move as many rings as possible from the two lower holes to the two upper holes, using both hands simultaneously, for six minutes. The number of rings carried during the six minutes constitutes the final score. Heart rate and oxygen saturation with pulse oximetry before and after the test, dyspnea, arm and general fatigue will be assessed.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start22 Jan 2020
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslihan Cakmak, Hacettepe University
- Investigators
- Aslihan Cakmak, MSc, Study director, Hacettepe UniversityDeniz Inal-Ince, PhD, Study chair, Hacettepe UniversityLutfi Coplu, MD, Principal investigator, Hacettepe UniversityHazal Sonbahar-Ulu, PhD, Principal investigator, Akdeniz UniversityEbru Calik-Kutukcu, PhD, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, PhD, Principal investigator, Hacettepe UniversityMelda Saglam, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084547
- Sponsor's protocol ID
- GO 20/55
- Status last verified
- Jan 2023
- First submitted
- 29 Sep 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cakmak A, Kocaaga E, Sonbahar-Ulu H, Inal-Ince D, Vardar-Yagli N, Calik-Kutukcu E, Saglam M, Coplu L. Upper Extremity Exercise Capacity and Activities of Daily Living in Individuals With Bronchiectasis Versus Healthy Controls. Phys Ther. 2023 Apr 4;103(4):pzad012. doi: 10.1093/ptj/pzad012.
PubMed 37086209
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Upper Extremity Exercise Capacity and Activities of Daily Living Between Subjects With Bronchiectasis and Healthy Controls
- ClinicalTrials.gov ID
- NCT05084547
- Acronym / sponsor ID
- GO 20/55
- Conditions
- Bronchiectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 20 Oct 2021 (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.
Bronchiectasis is a chronic lung disease characterized by permanent dilatation and destruction, resulting from the destruction of elastic tissue and muscular components in the bronchial walls, due to infection or inflammation. The exercise tolerance, physical activity level, respiratory and peripheral muscle strength of patients with bronchiectasis are lower than those of healthy individuals. The decrease in exercise tolerance occurs while performing upper extremity activities as well as lower extremity tasks. Many studies have reported that upper extremity exercise capacity is reduced in chronic obstructive pulmonary disease (COPD), a disease similar to bronchiectasis, and that patients often experience significant dyspnea and fatigue during upper extremity tasks that are important for daily life. The mechanisms causing this situation may be neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory muscles) (thoracoabdominal asynchrony) and changes in lung volume in activities involving the upper extremities. The disturbances in ventilatory mechanics in patients with COPD cause upper extremity exercise to be terminated at low workloads compared to healthy individuals. Upper extremity exercise has been defined as part of pulmonary rehabilitation. The determination of upper extremity exercise capacity may play a predictive role in maintaining and improving upper extremity and daily life activity level in patients with chronic lung disease.
Six-minute Pegboard and Ring test (6PBRT) is used to evaluate extremity exercise capacity and upper extremity function and endurance. The 6PBRT score and upper extremity daily living activities show a clear relationship in patients with COPD, and it can be used to determine and improve the performance of daily living activities in pulmonary rehabilitation programs. Glittre Activities of Daily Living (Glittre ADL test) covers activities that are necessary for daily living and commonly used activities. The Glittre ADL test produces similar cardiorespiratory responses when compared with the six-minute walk test. In this study, unsupported upper extremity exercise capacity and upper extremity function/endurance and the performance of daily living activities will be compared in participants with bronchiectasis and compared with healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: No interventionSubjects with Bronchiectasis |
| Control | – | Other: No interventionHealthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with bronchiectasis and healthy controls
Key inclusion criteria (3 listed)
- Diagnosed with bronchiectasis and being clinically stable,
- Being 18 years old or older,
- Being able and willing to complete the informed consent process.
Key exclusion criteria (5 listed)
- Individuals with bronchiectasis whose clinical condition is unstable,
- Individuals with bronchiectasis who have severe neuromuscular, musculoskeletal, and rheumatological problems,
- Being unable to cooperate,
- Not being willing to participate in the study
- The healthy controls will be composed of individuals who volunteered for the study without any known disease. Healthy individuals who did not volunteer to participate in the study will not be included.
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 |
|---|---|---|
| No interventionNo intervention | Other | Case, Control |
Primary outcome
Pulmonary function test - Forced vital capacity
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.
Pulmonary function test - Forced expiratory volume in one second
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second will be recorded.
Pulmonary function test - Forced expiratory volume in one second/Forced vital capacity
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced expiratory volume in one second/Forced vital capacity in one second will be recorded.
Pulmonary function test - Peak expiratory flow
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.
Pulmonary function test - Forced mid-expiratory flow (FEF25-75)
Time frame: 1st day
Pulmonary function test using a spirometer will be performed. Forced mid-expiratory flow (FEF25-75) will be recorded.
Glittre Activities of Daily Living Test
Time frame: 1st day
The test covers activities that are necessary for daily living and commonly used activities that are known to be difficult for patients with COPD.
Unsupported upper extremity exercise capacity
Time frame: 1st day
Upper extremity exercise capacity will be evaluated using 6PBRT. During the test, the patient is asked to sit in front of a pegboard and move as many rings as possible from the two lower holes to the two upper holes, using both hands simultaneously, for six minutes. The number of rings carried during the six minutes constitutes the final score. Heart rate and oxygen saturation with pulse oximetry before and after the test, dyspnea, arm and general fatigue will be assessed.
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 13 Jan 2023.
- Derived from this study: PubMed 37086209Cakmak A, Kocaaga E, Sonbahar-Ulu H, Inal-Ince D, Vardar-Yagli N, Calik-Kutukcu E, Saglam M, Coplu L. Upper Extremity Exercise Capacity and Activities of Daily Living in Individuals With Bronchiectasis Versus Healthy Controls. Phys Ther. 2023 Apr 4;103(4):pzad012. doi: 10.1093/ptj/pzad012.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis
RecruitingObservational study
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Bronchiectasis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Recruiting
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
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.
Aslihan Cakmak, MSc study director
Hacettepe University
Deniz Inal-Ince, PhD study chair
Hacettepe University
Lutfi Coplu, MD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Hacettepe 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 3 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: finished, as of the sponsor's last update on 13 Jan 2023. 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?
Pulmonary function test - Forced vital capacity (time frame: 1st day). 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?
On the ClinicalTrials.gov record for NCT05084547, which also lists 1 linked publication.
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 13 Jan 2023; AzTrials last refreshed its copy on 4 Nov 2026.