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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03902236
• Other study ID #: cfreactiontime
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: November 4, 2019

Study information

• Verified date: April 2019
• Source: Hacettepe University
• Contact: Jan Dik
• Phone: +90-537-572-9960
• Email: fztjandik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 4, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction Time and Postural Control	Reaction Time and Postural Control: With bunlar Fitlight TrainerTM mus, 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
Primary	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)
Primary	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
Primary	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