Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis

• Conditions: Bronchiectasis; Cystic Fibrosis
• Interventions: Other: Reaction Time and Postural Control; Other: Muscle oxygenation; Other: Exercise capacity; Other: Balance

• Registration Number: NCT03902236
• Lead Sponsor: Hacettepe University

Brief Summary

The aim of this study is to evaluate the reaction time and postural control and to investigate the relationship between reaction time, exercise capacity, muscle oxygenation and balance in children with cystic fibrosis (CF) and non-CF bronchiectasis. 40 patients including 20 CF patients and 20 non-CF bronchiectasis and 20 healthy individuals will be included in this study. Demographic and physical characteristics' will be recorded. Lung function testing will be performed. Balance will be assessed using functional reach test, exercise capacity was measured using the incremental shuttle walking test and reaction time will be assessed using ''Fitlight TrainerTM''. Heart rate, respiratory rate, oxygen saturation, muscle oxygenation, dyspnea and fatigue perception will be measured before and after exercise test and reaction time measurement.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-03
• Last Update Posted: 2019-04-03
• Primary Completion: 2019-10-07
• Study Completion: 2019-11-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children diagnosed with bronchiectasis and cystic fibrosis at 6-18 years old age for the bronchiectasis and cystic fibrosis groups respectively
• Healthy children at 6-18 years old age for the healthy group.
• Stable medical condition (free from the acute exacerbation)
• Children who have not participated in the planned exercise training program in the last 3 months
• Compliance with the tests

Exclusion Criteria

• Children who have a physical problems that limit the application of the tests
• Acute infection or unstable medical status

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystic fibrosis group	Muscle oxygenation	Children diagnosed with cystic fibrosis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Cystic fibrosis group	Reaction Time and Postural Control	Children diagnosed with cystic fibrosis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Bronchiectasis group	Muscle oxygenation	Children diagnosed with bronchiectasis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Bronchiectasis group	Balance	Children diagnosed with bronchiectasis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Healthy group	Muscle oxygenation	Healthy children more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Healthy group	Reaction Time and Postural Control	Healthy children more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Healthy group	Exercise capacity	Healthy children more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Healthy group	Balance	Healthy children more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Cystic fibrosis group	Exercise capacity	Children diagnosed with cystic fibrosis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Cystic fibrosis group	Balance	Children diagnosed with cystic fibrosis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Bronchiectasis group	Reaction Time and Postural Control	Children diagnosed with bronchiectasis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months
Bronchiectasis group	Exercise capacity	Children diagnosed with bronchiectasis more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months

Primary Outcome Measures

Name	Time	Method
Reaction Time and Postural Control	8 minutes	Reaction Time and Postural Control: With bunlar Fitlight TrainerTM muş, 6 led lights placed at certain points on the wall are randomly lit and expected to extinguish them as fast as possible. In the protocol, the leds will be placed according to the physical structure of the person, and the scores of 29 LEDs will be kept in seconds. The scores will be compared cystic fibrosis, bronciechtasis and healthy groups.
Muscle oxygenation	40 minutes (during the incremental shuttle walk test+reaction and postural control protocol)	Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronciechtasis and healthy groups.
Exercise capacity	20 minutes	Exercise capacity will be assessed with incremental shuttle walk test in cystic fibrosis, bronciechtasis and healthy groups.The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases.The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends The number of shuttles is recorded. Each shuttle represents a distance of ten metres
Balance	5 minutes	Balance will be assessed with functional reach test in cystic fibrosis, bronciechtasis and healthy groups Functional Reach measures the maximum distance a person can reach forward, the distance of the person standing at the edge of the wall with a 90-degree shoulder flexion and the maximum distance to the front of the thumb will be noted.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey