NCT03693664

Brief Summary

Exercise intolerance is one of the most problems in chronic obstructive pulmonary disease (COPD) and occurs not only in performing lower body tasks but also in performing arm activities. During arm exercise, auxiliary respiratory muscles are used for arm duty and cannot contribute to breathing. This increases the respiratory load of the diaphragm, which is mechanically disadvantageous, and results in thoracoabdominal synchronization disorder and severe dyspnea. Although the relationship between activity limitation and quality of life is clear in patients with exertional activity, the literature on physical activity is insufficient. Exercise and physical activity can also and exercise-related respiratory symptoms are known to have adverse effects on daily living activities (ADLs). There is no gold standard for objective assessment of activity limitation and exertional dyspnea in patients with asthma. Therefore, the results obtained by evaluating the validity and reliability of the 6PRT test in asthmatic patients in this study will increase the use of this test to test both arm endurance and arm exercise capacity in adult asthmatic patients, to estimate the effect on ADLs and to demonstrate the development obtained with pulmonary rehabilitation. .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 3, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

October 1, 2018

Last Update Submit

May 2, 2020

Conditions

Keywords

AsthmaDaily Living Activities6 Minute Pegboard and Ring Test

Outcome Measures

Primary Outcomes (1)

  • 6 minute Pegboard and Ring Test-6PRT

    Total number of rings installed within six minutes

    one year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Validity and reliability

You may qualify if:

  • To have a controlled or partially controlled asthma diagnosis, Have not experienced acute exacerbation in the last 3 months, Being between 18-80 years of age, Volunteer for research, To be able to walk and cooperate.

You may not qualify if:

  • To have a neurological disease or another clinical diagnosis that may affect cognitive status,
  • To have musculoskeletal and neurological disease, symptomatic heart disease, previous lung surgery and malignant disease that may affect exercise performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, Saglam M, Vardar-Yagli N, Sonbahar-Ulu H, Firat M, Arikan H, Kaya SB, Karakaya G. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. J Asthma. 2022 Jul;59(7):1387-1395. doi: 10.1080/02770903.2021.1930040. Epub 2021 May 31.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ebru Calik Kutukcu, Phd

    Hacettepe University Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

March 3, 2019

Primary Completion

February 3, 2020

Study Completion

February 3, 2020

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations