- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03902236
Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
April 2, 2019 updated by: Jan Dik, Hacettepe University
Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jan Dik
- Phone Number: +90-537-572-9960
- Email: fztjandik@gmail.com
Study Contact Backup
- Name: Melda Saglam
- Phone Number: 123 +90-312-305-1576
- Email: ptmeldaozturk@yahoo.com
Study Locations
-
-
-
Ankara, Turkey
- Recruiting
- Hacettepe University
-
Contact:
- Jan Dik
- Phone Number: +90-537-572-9960
- Email: fztjandik@gmail.com
-
Contact:
- Melda Saglam
- Phone Number: 123 +90-312-305-1576
- Email: ptmeldaozturk@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction Time and Postural Control
Time Frame: 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.
|
8 minutes
|
Muscle oxygenation
Time Frame: 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.
|
40 minutes (during the incremental shuttle walk test+reaction and postural control protocol)
|
Exercise capacity
Time Frame: 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
|
20 minutes
|
Balance
Time Frame: 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.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Klein 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Anticipated)
October 7, 2019
Study Completion (Anticipated)
November 4, 2019
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
April 3, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cfreactiontime
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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