NCT04153448

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 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

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 23, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

1 month

First QC Date

November 4, 2019

Last Update Submit

January 30, 2020

Conditions

Bronchiectasis

Keywords

BronchiectasisExercise capacitySix-minute walk testSit-to-stand test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of repetitions in sit-to-stand test

    1 Minute

  • Forced Vital Capacity (FVC)

    5 minutes

  • Forced Expiratory Volume in 1 second (FEV1)

    5 minutes

  • Peak Expiratory Flow (PEF)

    5 minutes

  • M. Quadriceps strength

    3 minutes

Study Arms (2)

Bronchiectasis

Children with bronchiectasis

Other: Measurement of functional capacity

Healthy Controls

Age-matched healthy volunteers

Other: Measurement of functional capacity

Interventions

Measurement of functional capacityOTHER

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

BronchiectasisHealthy Controls

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Diagnosis of non-cystic fibrosis bronchiectasis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

December 23, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)