Clinical trial NCT05084547: Comparison of Upper Extremity Exercise Capacity and ADL Between Subjects With Bronchiectasis and Healthy Controls
Official title: A Comparison of Upper Extremity Exercise Capacity and Activities of Daily Living Between Subjects With Bronchiectasis and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with bronchiectasis and healthy controls

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary function test - Forced vital capacity
timeFrame: 1st day
measure: Pulmonary function test - Forced expiratory volume in one second
timeFrame: 1st day
measure: Pulmonary function test - Forced expiratory volume in one second/Forced vital capacity
timeFrame: 1st day
measure: Pulmonary function test - Peak expiratory flow
timeFrame: 1st day
measure: Pulmonary function test - Forced mid-expiratory flow (FEF25-75)
timeFrame: 1st day
measure: Glittre Activities of Daily Living Test
timeFrame: 1st day
measure: Unsupported upper extremity exercise capacity
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Aslihan Cakmak, MSc
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Deniz Inal-Ince, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Lutfi Coplu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Hazal Sonbahar-Ulu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ebru Calik-Kutukcu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Melda Saglam, PhD
role: PRINCIPAL_INVESTIGATOR
References: