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

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ClinicalTrials.gov Identifier: NCT03902236
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jan Dik, 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.

Condition or disease Intervention/treatment
Cystic Fibrosis Bronchiectasis Other: Reaction Time and Postural Control Other: Muscle oxygenation Other: Exercise capacity Other: Balance

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 7, 2019
Estimated Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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
Other: Reaction Time and Postural Control
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.

Other: Muscle oxygenation
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups.

Other: Exercise capacity
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

Other: Balance
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
Other: Reaction Time and Postural Control
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.

Other: Muscle oxygenation
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups.

Other: Exercise capacity
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

Other: Balance
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
Other: Reaction Time and Postural Control
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.

Other: Muscle oxygenation
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups.

Other: Exercise capacity
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

Other: Balance
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902236


Contacts
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Contact: Jan Dik +90-537-572-9960 fztjandik@gmail.com
Contact: Melda Saglam +90-312-305-1576 ext 123 ptmeldaozturk@yahoo.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey
Contact: Jan Dik    +90-537-572-9960    fztjandik@gmail.com   
Contact: Melda Saglam    +90-312-305-1576 ext 123    ptmeldaozturk@yahoo.com   
Sponsors and Collaborators
Hacettepe University

Publications:
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Responsible Party: Jan Dik, Master of Science student, Hacettepe University
ClinicalTrials.gov Identifier: NCT03902236     History of Changes
Other Study ID Numbers: cfreactiontime
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jan Dik, Hacettepe University:
postural control
reaction time
cystic fibrosis
Bronchiectasis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Bronchiectasis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases