Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT04153448
Collaborator
(none)
80
1
1.2
64.1

Study Details

Study Description

Brief Summary

Children with bronchiectasis and age-matched healthy controls will be evaluated with sit-to-stand test and six-minute walk test and utilization of STST in determining functional capacity will be investigated.

Condition or Disease Intervention/Treatment Phase
  • Other: Measurement of functional capacity

Detailed Description

Bronchiectasis (BE) is a chronic condition which is characterized by the permanent abnormal widening of the bronchi as a result of repetitive airway infections and inflammation. Disabling cough and shortness of breath, excess mucus production, progressive airway obstruction and loss of skeletal muscle mass are the primary factors that impairs exercise tolerance in BE patients. Imaging modalities and pulmonary function test are insufficient to determine disease burden or the prognosis thus it is stated that exercise tolerance and quality of life should also be evaluated in these patients.

Exercise tolerance can be evaluated using cardiopulmonary exercise test by directly measuring oxygen consumption but the field tests such as six-minute walk test (6MWT), shuttle walk test or stair climbing tests also provides reliable data on exercise tolerance by measuring functional capacity. Among field tests, 6MWT is the most commonly used test for evaluating functional capacity in cardiopulmonary patients. Although 6MWT is easy to apply and does not require any special equipment, it still requires a 30-m long corridor and a total testing time of approx. 20 minutes considering the pre- and post-test resting periods which may impair its feasibility in some clinical settings.

Sit-to-stand test (STST) is firstly developed for older population to measure mobility related function and physical performance. Today, it is widely used in various populations including cardiopulmonary diseases such as cystic fibrosis, chronic obstructive pulmonary disease and heart failure. The investigator's aim in this study is to investigate whether STST is utilizable for evaluating functional capacity in children with BE.

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children
Actual Study Start Date :
Dec 23, 2019
Actual Primary Completion Date :
Jan 30, 2020
Actual Study Completion Date :
Jan 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Bronchiectasis

Children with bronchiectasis

Other: Measurement of functional capacity
Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test

Healthy Controls

Age-matched healthy volunteers

Other: Measurement of functional capacity
Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test

Outcome Measures

Primary Outcome Measures

  1. Six-minute walk test distance [15 minutes]

    Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).

Secondary Outcome Measures

  1. Number of repetitions in sit-to-stand test [1 Minute]

    Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.

  2. Forced Vital Capacity (FVC) [5 minutes]

    FVC will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

  3. Forced Expiratory Volume in 1 second (FEV1) [5 minutes]

    FEV1 will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

  4. Peak Expiratory Flow (PEF) [5 minutes]

    PEF will be measured using basic spirometry and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)

  5. M. Quadriceps strength [3 minutes]

    Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Diagnosis of non-cystic fibrosis bronchiectasis
Exclusion Criteria:
  • Hospitalization history in past month

  • Diagnosis of other chronic pediatric diseases which may impair exercise tolerance such as cerebral palsy or neuromuscular disease

  • Candidates for lung transplantation or history of lung transplantation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakif University Istanbul Turkey

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melih Zeren, Assistant Professor, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT04153448
Other Study ID Numbers:
  • bvumzeren04
First Posted:
Nov 6, 2019
Last Update Posted:
Jan 31, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Melih Zeren, Assistant Professor, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2020