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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children diagnosed with non-cystic fibrosis bronchiectasis and age matched healthy volunteers who do not have any diagnosed chronic diseases

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test distance	Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of repetitions in sit-to-stand test	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.	1 Minute
Forced Vital Capacity (FVC)	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)	5 minutes
Forced Expiratory Volume in 1 second (FEV1)	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)	5 minutes
Peak Expiratory Flow (PEF)	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 minutes
M. Quadriceps strength	Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.	3 minutes

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 23, 2019
• Primary Completion (ACTUAL): January 30, 2020
• Study Completion (ACTUAL): January 30, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (ACTUAL): November 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Bronchiectasis; Exercise capacity; Six-minute walk test; Sit-to-stand test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: bvumzeren04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No