BronchiectasisNCT06606665
Balance, Cognıtıve Skılls, Hand Functıons and Qualıty of Lıfe Among Patients with Bronchiectasis and Healthy Peers
An observational study of Bronchiectasis, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to comparatively evaluate the parameters of balance, cognitive skills, hand grip strength, reaction time, quality of life and respiratory functions in elderly and healthy peers individuals. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Cognitive skills test, Reaction time test and Quality of life assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 10 Jun 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly with diagnosed with bronchiectasis and age matched healthy volunteers who do not have any diagnosed chronic diseases.
Who may be able to join
- Clinically diagnosed with bronchiectasis and in stable condition,
- No known systemic, orthopedic or neurological disease,
- Can walk,
- Volunteer for research,
- Able to cooperate,
- Elderly individuals aged 65 and over with bronchiectasis
- Healthy elderly individuals aged 65 and over
Who cannot join
- Individuals under 65 years of age
- Individuals with FEV1 values < 40%
- History of uncontrolled hypertension, arrhythmia and MI in the last month
- Having a history of lung or liver transplantation,
- Unstable angina,
- Those with serious cardiac problems such as advanced heart failure,
Show all 13Show fewer
- Hemodynamically unstable cases,
- Those who have used antibiotics in the last three weeks,
- Those with acute exacerbation
- Those with insufficient awareness and cooperation,
- Those with pregnancy and malignancy,
- Those who have orthopedic or surgical problems that may prevent tests,
- Those who did not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparıson of Balance, Cognıtıve Skılls, Hand Functıons and Qualıty of Lıfe Between Elderly Patıents Wıth Bronchiectasis and Healthy Peers
The aim of this study is to comparatively evaluate the parameters of balance, cognitive skills, hand grip strength, reaction time, quality of life and respiratory functions in elderly and healthy peers individuals.
Read the detailed description
Deterioration of airway patency, respiratory functions, experiencing shortness of breath that limits functional capacity, impairments in health-related quality of life, balance, cognitive skills, hand grip strength and reaction time parameters make physiotherapy approaches important in the treatment of bronchiectasis.
- Conditions
- Bronchiectasis
- Being tested
- Cognitive skills test, Reaction time test, Quality of life assessment, Lower extremity muscle strength assessment, Hand grip strength measurement test
- Keywords
- bronchiectasis, elderly, balance, cognitive ability, hand grip strength, hand functions, quality of life, lower extremity muscle strength, respiratory function parameters, reaction time
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive skills testOther
Also called MOCA
Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale.
Reaction time testOther
Also called 12-Red Square Test
Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet.
Quality of life assessmentOther
Also called NIH
Quality of life assessment; It will be evaluated with the Nottingham Health Profile.
Lower extremity muscle strength assessmentOther
Also called 30-second sit-and-stand test
Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test.
Hand grip strength measurement testOther
Also called dynamometer
Hand grip strength measurement test; It will be evaluated with a dynamometer.
Pulmonary function assessmentOther
Also called spirometry
Pulmonary function assessment; It will be evaluated by spirometry.
Balance assessmentOther
Also called Wii Fit Balance Board
Balance assessment will be done with the Wii Fit Balance Board.
| Study group | Role | What they receive |
|---|---|---|
| elderly with bronchiectasis ( EXPERİMENTAL GROUP ) | elderly with bronchiectasis
Interventions:
Other: Participants will have to sign an informed consent form before the evaluation.
Demographic information; It will be evaluated with a demographic information evaluation form.
Other: Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale.
Other: Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet.
Other: Quality of life assessment; It will be evaluated with the Nottingham Health Profile.
Other: Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test.
Other: Hand grip strength measurement test; It will be evaluated with a dynamometer.
Other: Pulmonary function assessment; It will be evaluated by spirometry. Other: Balance assessment will be done with the Wii Fit Balance Board. Receives: Other: Cognitive skills test; Other: Reaction time test; Other: Quality of life assessment; Other: Lower extremity muscle strength assessment; Other: Hand grip strength measurement test; Other: Pulmonary function assessment; Other: Balance assessment | |
| healthy controls (CONTROL GROUP) | Age-matched healthy volunteers
Interventions:
Other: Participants will have to sign an informed consent form before the evaluation.
Demographic information; It will be evaluated with a demographic information evaluation form.
Other: Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale.
Other: Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet.
Other: Quality of life assessment; It will be evaluated with the Nottingham Health Profile.
Other: Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test.
Other: Hand grip strength measurement test; It will be evaluated with a dynamometer.
Other: Pulmonary function assessment; It will be evaluated by spirometry. Other: Balance assessment will be done with the Wii Fit Balance Board. Receives: Other: Cognitive skills test; Other: Reaction time test; Other: Quality of life assessment; Other: Lower extremity muscle strength assessment; Other: Hand grip strength measurement test; Other: Pulmonary function assessment; Other: Balance assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wii Fit Balance Board
The use of force platform technologies to assess standing balance is common in a variety of clinical areas. Force platforms can provide detailed quantitative information about underlying movement deficits or postural control mechanisms and responses to sensory manipulations. Force platforms are now considered the gold standard in clinical practice. A reliable and valid study in which the Wii Fit Balance Board can be used as a tool to assess balance was conducted by Clark et al. (2018) In the balance test with Nintendo Wii Balance Board; The participant is asked to complete the 'Basic Balance Test' with their eyes open, within 30 seconds, in 5 stages, with gradually increasing difficulty, using weight transfer to the right and left. The maximum total score that can be obtained from the test is determined as 30.
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Secondary outcomes (6)
Montreal Cognitive Assessment Scale.
Montreal Cognitive Assessment Scale; In order to distinguish normal individuals from individuals with mild mental problems, Nasreddine et al. (2005). Adaptation of the scale to Turkish was made by Selekler et al. (2010). In this study, the cut-off point of the Turkish version of the scale (21 points) was found to be lower than the original version (26 points).
The highest score that can be obtained from the scale is 30 and the minimum score is 0.
In the obtained scores, <10 indicates severe cognitive impairment, 10-17 indicates moderate cognitive impairment, 18-25 indicates mild cognitive impairment, and >26 indicates normal cognition.
The abbreviation of the scale is "MOCA".
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
APP- Coo-Test
APP-coo-test; It is an application that contains 4 different tests to measure reaction time. The first part consists of 15 white dot tests that test upper extremity coordination, the second part consists of 12 Red Square Tests that test upper extremity speed-coordination, and the third and fourth parts consist of static balance tests. 12 Red Square Tests; It is an application that runs on a touch screen device and can be downloaded from the web for free. It measures the time required to perform the task, in addition, it provides the 12-Red Square Test execution time, average time, standard deviation of trials executed, and coefficient of variation of each upper extremity (dominant and non-dominant hands) at the end of the test. PDF report can be downloaded, printed and signed by the auditor for safekeeping.
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Nottingham Health Profile (NIH)
Nottingham Health Profile is a quality of life questionnaire, developed in 1975 at the Department of Public Health, University of Nottingham, Faculty of Medicine, England, consisting of two parts, which questions some problems in daily life that require the person to answer himself . The abbreviation of the questionnaire is "NHP".
Cronbach's α value calculated in all areas of the scale was calculated between 0.56 and 0.83. As a result of the calculations, a result between 0-100 is obtained. A score approaching 100 indicates a low level of perceived health status, and a score approaching 0 indicates a high level of perceived health status.
The Turkish validity and reliability study of the questionnaire was conducted by Küçükdeveci et al. in 2000.
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
30 Second Sit and Stand Test
30 Second Sit and Stand Test; It is used to evaluate the lower extremity muscle strength and endurance of individuals. At the beginning of the test, individuals are seated on a standard stool with back support, without armrests, approximately 45 cm tall, with their feet flat on the ground and their hands crossed over their shoulders. The test is first demonstrated by a staff member and then administered by a subject. Starting from this position, the patient is asked to sit and stand up as quickly as possible for 30 seconds. The number of times you sit down and stand up correctly for 30 seconds is recorded as the test result. In the literature, the minimum significant difference of the 30-second sit-to-stand test has been determined as 3 repetitions.
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Hand Grip Force Test
The grip strength test is performed with a dynamometer according to the recommendations of the American Hand Therapists Association. Patients are measured in a sitting position, shoulder adduction, elbow flexion at 90°, forearm prono-supination in neutral and wrist joint in neutral position. 3 consecutive measurements are provided with 60-second rest breaks between measurements. The result obtained from the average of the three measurements is recorded.
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Pulmonary Function Test
The Pulmonary Function Test is a physiological test that measures airflow or lung volume changes during inspiration and expiration, according to the derivative of time. Its abbreviation is "SFT". Spirometer, on the other hand, is a pulmonary function test device that provides an objective demonstration of the capacity of the lungs and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start20 Oct 2023
- Primary completion20 Apr 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Denizoğlu Külli, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606665
- Sponsor's protocol ID
- IAU-SBE-VHB-01
- Status last verified
- Feb 2025
- First submitted
- 18 Sep 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparıson of Balance, Cognıtıve Skılls, Hand Functıons and Qualıty of Lıfe Between Elderly Patıents Wıth Bronchiectasis and Healthy Peers
- ClinicalTrials.gov ID
- NCT06606665
- Acronym / sponsor ID
- IAU-SBE-VHB-01
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, elderly, balance, cognitive ability, hand grip strength, hand functions, quality of life, lower extremity muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 23 Sep 2024 (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 comparatively evaluate the parameters of balance, cognitive skills, hand grip strength, reaction time, quality of life and respiratory functions in elderly and healthy peers individuals.
Detailed description
Deterioration of airway patency, respiratory functions, experiencing shortness of breath that limits functional capacity, impairments in health-related quality of life, balance, cognitive skills, hand grip strength and reaction time parameters make physiotherapy approaches important in the treatment of bronchiectasis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly with bronchiectasis ( EXPERİMENTAL GROUP ) | – | Other: Cognitive skills test, Other: Reaction time test, Other: Quality of life assessment, Other: Lower extremity muscle strength assessment, Other: Hand grip strength measurement test, Other: Pulmonary function assessment, Other: Balance assessmentelderly with bronchiectasis Interventions: Other: Participants will have to sign an informed consent form before the evaluation. Demographic information; It will be evaluated with a demographic information evaluation form. Other: Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale. Other: Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet. Other: Quality of life assessment; It will be evaluated with the Nottingham Health Profile. Other: Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test. Other: Hand grip strength measurement test; It will be evaluated with a dynamometer. Other: Pulmonary function assessment; It will be evaluated by spirometry. Other: Balance assessment will be done with the Wii Fit Balance Board. |
| healthy controls (CONTROL GROUP) | – | Other: Cognitive skills test, Other: Reaction time test, Other: Quality of life assessment, Other: Lower extremity muscle strength assessment, Other: Hand grip strength measurement test, Other: Pulmonary function assessment, Other: Balance assessmentAge-matched healthy volunteers Interventions: Other: Participants will have to sign an informed consent form before the evaluation. Demographic information; It will be evaluated with a demographic information evaluation form. Other: Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale. Other: Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet. Other: Quality of life assessment; It will be evaluated with the Nottingham Health Profile. Other: Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test. Other: Hand grip strength measurement test; It will be evaluated with a dynamometer. Other: Pulmonary function assessment; It will be evaluated by spirometry. Other: Balance assessment will be done with the Wii Fit Balance Board. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly with diagnosed with bronchiectasis and age matched healthy volunteers who do not have any diagnosed chronic diseases.
Key inclusion criteria (7 listed)
- Clinically diagnosed with bronchiectasis and in stable condition,
- No known systemic, orthopedic or neurological disease,
- Can walk,
- Volunteer for research,
- Able to cooperate,
Key exclusion criteria (13 listed)
- Individuals under 65 years of age
- Individuals with FEV1 values < 40%
- History of uncontrolled hypertension, arrhythmia and MI in the last month
- Having a history of lung or liver transplantation,
- Unstable angina,
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 |
|---|---|---|
| Cognitive skills testAlso: MOCACognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
| Reaction time testAlso: 12-Red Square TestReaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
| Quality of life assessmentAlso: NIHQuality of life assessment; It will be evaluated with the Nottingham Health Profile. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
| Lower extremity muscle strength assessmentAlso: 30-second sit-and-stand testLower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
| Hand grip strength measurement testAlso: dynamometerHand grip strength measurement test; It will be evaluated with a dynamometer. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
| Pulmonary function assessmentAlso: spirometryPulmonary function assessment; It will be evaluated by spirometry. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
| Balance assessmentAlso: Wii Fit Balance BoardBalance assessment will be done with the Wii Fit Balance Board. | Other | elderly with bronchiectasis ( EXPERİMENTAL GROUP ), healthy controls (CONTROL GROUP) |
Primary outcome
Wii Fit Balance Board
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
The use of force platform technologies to assess standing balance is common in a variety of clinical areas. Force platforms can provide detailed quantitative information about underlying movement deficits or postural control mechanisms and responses to sensory manipulations. Force platforms are now considered the gold standard in clinical practice. A reliable and valid study in which the Wii Fit Balance Board can be used as a tool to assess balance was conducted by Clark et al. (2018) In the balance test with Nintendo Wii Balance Board; The participant is asked to complete the 'Basic Balance Test' with their eyes open, within 30 seconds, in 5 stages, with gradually increasing difficulty, using weight transfer to the right and left. The maximum total score that can be obtained from the test is determined as 30.
6 secondary outcomes
Montreal Cognitive Assessment Scale.
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
APP- Coo-Test
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Nottingham Health Profile (NIH)
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
30 Second Sit and Stand Test
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Hand Grip Force Test
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Pulmonary Function Test
Time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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Bronchiectasis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 7 inclusion and 13 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 26 Feb 2025. 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?
Wii Fit Balance Board (time frame: The assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.). 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 26 Feb 2025.