Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2019
CompletedApril 3, 2019
April 1, 2019
7 months
April 1, 2019
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Reaction Time and Postural Control
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.
8 minutes
Muscle oxygenation
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronciechtasis and healthy groups.
40 minutes (during the incremental shuttle walk test+reaction and postural control protocol)
Exercise capacity
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
20 minutes
Balance
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.
5 minutes
Study Arms (3)
Cystic fibrosis group
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
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
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
Interventions
Reaction Time and Postural Control: With ''Fitlight TrainerTM'', 6 light emitting diode (LED) lights placed at certain points on the wall are randomly lit and expected to deactivate 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 LED's will be kept in seconds. The scores will be compared cystic fibrosis, bronchiectasis and healthy groups.
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups.
Exercise capacity will be assessed with incremental shuttle walk test in cystic fibrosis, bronchiectasis 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 will be assessed with functional reach test in cystic fibrosis, bronchiectasis 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.
Eligibility Criteria
Children diagnosed with cystic fibrosis and bronchiectasis is referred from Hacettepe University, Pediatric Chest Diseases Department to Hacettepe University Department of Physiotheraphy and Rehabilitation will be included in this study. And also, healthy children at 6-18 years olds who are relatives of patients admitted to the our department will be included in this study.
You may qualify if:
- 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
You may not qualify if:
- Children who have a physical problems that limit the application of the tests
- Acute infection or unstable medical status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, Turkey (Türkiye)
Related Publications (2)
Borges NR, Driller MW. Wearable Lactate Threshold Predicting Device is Valid and Reliable in Runners. J Strength Cond Res. 2016 Aug;30(8):2212-8. doi: 10.1519/JSC.0000000000001307.
PMID: 27457915BACKGROUNDKlein M, Gauggel S, Sachs G, Pohl W. Impact of chronic obstructive pulmonary disease (COPD) on attention functions. Respir Med. 2010 Jan;104(1):52-60. doi: 10.1016/j.rmed.2009.08.008. Epub 2009 Sep 11.
PMID: 19748260BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Science student
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
March 1, 2019
Primary Completion
October 7, 2019
Study Completion
November 4, 2019
Last Updated
April 3, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share