NCT05084547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

September 29, 2021

Last Update Submit

January 12, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Pulmonary function test - Forced vital capacity

    Pulmonary function test using a spirometer will be performed. Forced vital capacity will be recorded.

    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.

    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.

    1st day

  • Pulmonary function test - Peak expiratory flow

    Pulmonary function test using a spirometer will be performed. Peak expiratory flow will be recorded.

    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.

    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.

    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.

    1st day

Study Arms (2)

Case

Subjects with Bronchiectasis

Other: No intervention

Control

Healthy Controls

Other: No intervention

Interventions

No intervention

CaseControl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with bronchiectasis and healthy controls

You may qualify if:

  • Diagnosed with bronchiectasis and being clinically stable,
  • Being 18 years old or older,
  • Being able and willing to complete the informed consent process.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Aslihan Cakmak, MSc

    Hacettepe University

    STUDY DIRECTOR
  • Deniz Inal-Ince, PhD

    Hacettepe University

    STUDY CHAIR
  • Lutfi Coplu, MD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Hazal Sonbahar-Ulu, PhD

    Akdeniz University

    PRINCIPAL INVESTIGATOR
  • Ebru Calik-Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Melda Saglam, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 20, 2021

Study Start

January 22, 2020

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations