Cystic FibrosisNCT03902236
Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
An observational study of Cystic Fibrosis and Bronchiectasis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Bronchiectasis
- What is being tested?
- Muscle oxygenation, Exercise capacity and Balance
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 4 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Children who have a physical problems that limit the application of the tests
- Acute infection or unstable medical status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Jan Dik, +90-537-572-9960, fztjandik@gmail.com
Melda Saglam, +90-312-305-1576 ext. 123, ptmeldaozturk@yahoo.com
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Being tested
- Reaction Time and Postural Control, Muscle oxygenation, Exercise capacity, Balance
- Keywords
- postural control, reaction time, cystic fibrosis, Bronchiectasis
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reaction Time and Postural ControlOther
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 oxygenationOther
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups.
Exercise capacityOther
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
BalanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Reaction Time and Postural Control; Other: Muscle oxygenation; Other: Exercise capacity; Other: Balance | |
| 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 Receives: Other: Reaction Time and Postural Control; Other: Muscle oxygenation; Other: Exercise capacity; Other: Balance | |
| 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 Receives: Other: Reaction Time and Postural Control; Other: Muscle oxygenation; Other: Exercise capacity; Other: Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 minutes
Muscle oxygenation
Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronciechtasis and healthy groups.
Measured: 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
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start1 Mar 2019
- Primary completion7 Oct 2019 (estimated)
- Study completion4 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Dik, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902236
- Sponsor's protocol ID
- cfreactiontime
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27457915Klein 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.
PubMed 19748260
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis
- ClinicalTrials.gov ID
- NCT03902236
- Acronym / sponsor ID
- cfreactiontime
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Keywords
- postural control, reaction time, cystic fibrosis, Bronchiectasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 7 Oct 2019 (estimated)
- Study completion
- 4 Nov 2019 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis group | – | Other: Reaction Time and Postural Control, Other: Muscle oxygenation, Other: Exercise capacity, Other: BalanceChildren 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 | – | Other: Reaction Time and Postural Control, Other: Muscle oxygenation, Other: Exercise capacity, Other: BalanceChildren 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 | – | Other: Reaction Time and Postural Control, Other: Muscle oxygenation, Other: Exercise capacity, Other: BalanceHealthy children more than 6 years old Stable medical condition Those who have not participated in a planned training program in the last 3 months |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Children who have a physical problems that limit the application of the tests
- Acute infection or unstable medical status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reaction Time and Postural ControlReaction 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 | Bronchiectasis group, Cystic fibrosis group, Healthy group |
| Muscle oxygenationMuscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups. | Other | Bronchiectasis group, Cystic fibrosis group, Healthy group |
| Exercise capacityExercise 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 | Bronchiectasis group, Cystic fibrosis group, Healthy group |
| BalanceBalance 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. | Other | Bronchiectasis group, Cystic fibrosis group, Healthy group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 27457915Borges 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.
- Background: PubMed 19748260Klein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Bronchiectasis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Dik (+90-537-572-9960, fztjandik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time and Postural Control (time frame: 8 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902236, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.