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

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153448
• Other study ID #: bvumzeren04
• Status: Completed
• Start date: December 23, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: January 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	M. Quadriceps strength	Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.	3 minutes