Trial record 1 of 301948 for:
ALL
Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
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| ClinicalTrials.gov Identifier: NCT03902236 |
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Recruitment Status :
Recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
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Sponsor:
Hacettepe University
Information provided by (Responsible Party):
Jan Dik, Hacettepe University
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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 |
| 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
Genetics Home Reference related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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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. |
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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
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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. |
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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
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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 :
- 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.
- 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.
- 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
- 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.
Information from the National Library of Medicine
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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
| Contact: Jan Dik | +90-537-572-9960 | fztjandik@gmail.com | |
| Contact: Melda Saglam | +90-312-305-1576 ext 123 | ptmeldaozturk@yahoo.com |
Locations
| 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:
| 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 |
| 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:
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postural control reaction time cystic fibrosis Bronchiectasis |
Additional relevant MeSH terms:
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Fibrosis Cystic Fibrosis Bronchiectasis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Bronchial Diseases |