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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05084547
Other study ID # GO 20/55
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 22, 2020
Est. completion date December 22, 2022

Study information

Verified date January 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 22, 2022
Est. primary completion date December 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with bronchiectasis and being clinically stable, - Being 18 years old or older, - Being able and willing to complete the informed consent process. Exclusion criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary function test - Forced vital capacity Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded. 1st day
Primary 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. 1st day
Primary 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. 1st day
Primary Pulmonary function test - Peak expiratory flow Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded. 1st day
Primary 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. 1st day
Primary 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. 1st day
Primary 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. 1st day
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