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BronchiectasisNCT06630403

Evaluation of Motor Imagery, Cognitive Function and Reaction Time in Children With Bronchiectasis

An observational study of Bronchiectasis, run by Atlas University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to evaluate motor imagery ability, reaction time and cognitive function parameters in children with CF and non-CF bronchiectasis compared to healthy peers. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Bronchiectasis
What is being tested?
Demographic Data, Disease History and Pulmonary Function Test
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Sep 2023to 1 Jan 2024
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 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Twenty patients with bronchiectasis and 20 healthy individuals who met the inclusion criteria applied to the study. The study consisted of 2 groups, experimental and control.

Who may be able to join

  • Diagnosed with cystic or non-cystic bronchiectasis
  • Being clinically stable
  • Not having an exacerbation or infection
  • Being between the ages of 7-18
  • To be able to read and understand Turkish

Who cannot join

  • Unstable concomitant cardiac, orthopedic or neurologic disease
  • History of previous lung or liver transplantation
  • History of acute exacerbation and/or hospitalization in the last 1 month
  • Changes in medical treatment during the study period.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Atlas University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

The aim of this study was to evaluate motor imagery ability, reaction time and cognitive function parameters in children with CF and non-CF bronchiectasis compared to healthy peers.

Read the detailed description

The main causes affecting exercise capacity in patients with bronchiectasis are restriction of tidal expiratory flow, dyspnea secondary to dynamic hyperinflation, changes in pulmonary mechanics, inadequate gas exchange and decreased skeletal muscle mass. Due to all these symptoms, exercise capacity decreases in patients with bronchiectasis and the importance of physical activity increases. . In addition to decreased exercise capacity in individuals with bronchiectasis, studies on the effect of motor imagery ability, which is considered as a mental exercise, have not been found. Inadequate blood supply to the brain and muscle dysfunction have been reported to cause cognitive damage and decreased reaction time in COPD patients.

Conditions
Bronchiectasis
Being tested
Demographic Data, Disease History, Pulmonary Function Test, Reaction Time, Functional Capacity
Keywords
bronchiectasis, cognitive function, motor imagery
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Demographic DataOther

    Demographic data (age, height, weight, BMI) will be collected verbally through an assessment form.

  • Disease HistoryOther

    The number of exacerbations in the last 1 year, hospitalization and medications used will be questioned.

  • Pulmonary Function TestOther

    Pulmonary Function Test will be performed with a spirometer.

  • Reaction TimeOther

    Reaction time will be evaluated with the Nelson Hand-Foot Reaction Test.

  • Functional CapacityOther

    Functional capacity will be evaluated with 6 minute walk test

  • Dyspnea PerceptionOther

    Dalhousie Dyspnea and Perceived Exertion Scale will be used to determine the level of dyspnea

  • Quality of LifeOther

    Quality of life will be assessed with the "Quality of Life Scale for Children\"

  • Fear of movementOther

    Fear of movement will be evaluated with Tampa Kinesiophobia Scale

  • Ability of Motor ImageryOther

    Motor Imagery ability will be assessed by Movement Imagery Questionnaire-3 and Vividness of Movement Imagery

  • Cognitive FunctionsOther

    Cognitive functions will be assessed with Trail Making Test and Stroop Test

Study groups in NCT06630403
Study groupRoleWhat they receive
Children with Bronchiectasis Experiment GroupChildren with bronchiectasis Participants will be required to sign an informed consent form before the evaluation. Assesment Methods: 1. Demographic data will be collected verbally. 2. The number of exacerbations in the last 1 year, hospitalization and medications used will be questioned. 3. Pulmonary Function Test will be applied. 4. Reaction time will be evaluated with the Nelson Hand-Foot Reaction Test. 5. Functional capacity of the patient will be evaluated with the 6 Minute Walk Test. 6. Dalhousie Dyspnea and Perceived Exertion Scale will be used to determine the level of dyspnea. 7. Quality of life will be assessed with the "Quality of Life Scale for Children". 8. Fear of movement will be assessed with the Tampa Kinesiophobia Scale. 9. Motor Imagery ability will be assessed with the Movement Imagery Questionnaire-3, Vividness of Movement Imagery. 10. Cognitive functions will be assessed with Trail Making Test and Stroop Test.
Receives: Other: Demographic Data; Other: Disease History; Other: Pulmonary Function Test; Other: Reaction Time; Other: Functional Capacity; Other: Dyspnea Perception; Other: Quality of Life; Other: Fear of movement; Other: Ability of Motor Imagery; Other: Cognitive Functions
Healthy ControlsHealthy Peers Participants will be required to sign an informed consent form before the evaluation. Assessment Methods: 1. Demographic data (age, height, weight, BMI) will be collected verbally via the assessment form. 2. Pulmonary Function Test will be applied. 3. Reaction time will be evaluated with the Nelson Hand-Foot Reaction Test. 4. Functional capacity of the patient will be evaluated with the 6 Minute Walk Test. 5. Dalhousie Dyspnea and Perceived Exertion Scale will be used to determine the level of dyspnea. 6. Quality of life will be assessed with the "Quality of Life Scale for Children". 7. Fear of movement will be assessed with the Tampa Kinesiophobia Scale. 8. Motor Imagery ability will be assessed with the Movement Imagery Questionnaire-3, Vividness of Movement Imagery. 9. Cognitive functions will be assessed with Trail Making Test and Stroop Test.
Receives: Other: Demographic Data; Other: Pulmonary Function Test; Other: Reaction Time; Other: Functional Capacity; Other: Dyspnea Perception; Other: Quality of Life; Other: Fear of movement; Other: Ability of Motor Imagery; Other: Cognitive Functions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trail Making Test

    The Trail Making Test is divided into two parts. In the first part, the participant is asked to connect the 23 numbers in the circle randomly placed on the page with a pencil in an orderly order, and in the second part, the participant is asked to draw and connect the 23 numbers and letters in the circle in a mixed order. In the second part, the individual has to change sets between one letter and one number. (1- A, 2-B, 3-C, 4-D, etc.).The test can be applied between the ages of 8-79.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  2. Stroop Test

    The Stroop Test consists of four parts. The first part contains words written in black (e.g blue), the second part contains colors and the last part contains words written in different colors (e.g. the word blue written in red ink). The participant is expected to fulfill these tasks in turn. The participant has to correctly read the words in the first part, say the colors in the next part, read the colored word in the third part, and then say the color in which the word is written in the last part.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  3. Nelson Hand Reaction Test

    The tester holds the ruler by the tip and between the thumb and index fingers of the subject and releases the ruler. When the ruler is released, the participant is asked to catch the ruler. The participants hand is fixed and 20 trials are performed in the test. At the top point where the subject grabs the ruler with his/her fingers, the reaction time of the subject is determined. The highest and lowest five trials are discarded and the remaining ones are averaged.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  4. Nelson Foot Reaction Test

    The participant removes his/her shoes and sits with the toe 2.5 cm from the wall and the heel 5 cm. The tester holds the reaction time ruler at the edge of the wall and between the wall and the subjects foot, with the baseline at the tip of the thumb. The subject is instructed to look at the concentration line and to hold the ruler, which falls after the ready command, by pinching it against the wall with the toe of the foot. This test is repeated 20 times.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  5. Movement Imagery Questionnaire-3

    It consists of 3 subscales evaluating external visual imagery, internal visual imagery and kinesthetic imagery and a total of 12 items. Before scoring each movement, the participant is asked to perform the movement and then the movement is imaged three times. Scoring is done between 1 and 7, with "1 point: very difficult to see/feel, 7 points: very easy to see/feel". A maximum score of 84 can be obtained on the MIQ-3 questionnaire. A higher score on the test means that the person has a better ability to visualize.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes

  6. Vividness of Motion Imagery Questionnaire

    In the Vividness of Movement Imagery questionnaire, the person does not need to perform the movements before visualizing them. This scale consists of four scenarios and you are asked to rank on a scale of one to five how vividly you picture them in the participant mind. Each scenario asks you to imagine the face of a loved one, a view of your favorite grocery store or a beautiful landscape and rate the vividness of the details in each scene. The individual is asked to imagine 4 scenarios first with eyes open and then with eyes closed. As a result of this situation, the individual can reach a maximum of 160 in total score.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes

Secondary outcomes (6)
  1. Dalhousie Dyspnea and Perceived Exertion Scale

    It consists of seven pictures each showing the three dyspnea constructs (chest tightness, throat closure and effort to breathe), plus an additional pictorial scale showing leg effort.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  2. 6 Minute Walk Test

    6MWT is defined as a submaximal test that can be easily applied in healthy or unhealthy individuals and is evaluated as an indicator of exercise capacity and walking capacity as well as many cardiovascular diseases. The 6MWT is referred to as the "Gold Standard" test of walking capacity. The aim of this test is to reach the longest possible walking distance at the end of six minutes. The standard protocol is applied in a 30-meter uninterrupted corridor or open area. It is recommended to repeat the 6MWT three times on the same day with a one-hour rest interval; the maximum walking distance is taken into account.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  3. Quality of Life Scale for Children

    This scale consists of a total of 23 items and 4 subscales, including 8 items measuring physical functioning, 5 items measuring emotional functioning, 5 items measuring social functioning and 5 items assessing school functioning. In the instructions in the scale, it is asked to determine how much the issue mentioned in the items has been a problem for the parent or child in the last month. Answers are given on a 5-point ordinal scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always). By inverting the scores (e.g. 0 → 100, 1 → 75, 2 → 50, 3 → 25, 4 → 0), a quality of life score between 0% and 100% is calculated for each section. A high score means that the participant has a high quality of life.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  4. Tampa Kinesiophobia Scale

    It is a 17-question scale developed to measure fear of movement/reinjury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. The scale uses a 4-point Likert scale (1=strongly disagree, 4=strongly agree). A high score on the scale indicates a high level of kinesiophobia. A score of 37 and above indicates kinesiophobia (fear of movement).

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  5. Respiratory Function Test

    Pulmonary function will be evaluated with a spirometer according to the American Thoracic Society and European Respiratory Society criteria. The device replaces the hand-held flow sensor, traditionally placed in the mouth, with the same sensor being secured to the face using straps and a mask. Participants will be asked to take a deep breath and then perform a strong and complete exhalation. This maneuver will be repeated three times, and the best of the three measurements, with a difference of less than 0.150 L between them, will be recorded. The participants; forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio (FEV1/FVC), peak expiratory flow (PEF), and forced expiratory flow at 25-75% (FEF25-75%) will be measured. When data such as age, gender, race, height, and weight are entered into the device, the expected values of all parameters will be calculated based on normative values.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

  6. Demographic and Clinical Data Collection Form

    Participants; gender, date of birth, height in meters, weight in kilograms, body mass index in kg/m2, contact information, date and method of diagnosis, presence of chronic disease, medications/devices used, number of acute exacerbations and hospitalization history of the patient in the last year, presence of disease symptoms, previous surgery/trauma history, previous physiotherapy and rehabilitation program, background and family history information will be recorded.

    Measured: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start5 Sep 2023
  3. Primary completion1 Jan 2024
  4. Study completion1 Jan 2024

Resources

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
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630403
Sponsor's protocol ID
Aysenur Temizel Tombul
Status last verified
Oct 2024
First submitted
17 Sep 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiectasis, run by Atlas 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 4 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: finished, as of the sponsor's last update on 8 Oct 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trail Making Test (time frame: The assessment will be administered only once to each participant. All tests will take place on the same day and will last approximately 60 minutes.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Oct 2024.

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