CClinicalTrials.gg
CompletedNCT06606665Updated Feb 26, 2025

Balance, Cognıtıve Skılls, Hand Functıons and Qualıty of Lıfe Among Patients with Bronchiectasis and Healthy Peers

An observational study in Bronchiectasis, sponsored by Atlas University. Completed at 1 site in Turkey. Open to participants aged 65 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Atlas University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
65 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bronchiectasis

Browse trials for

Keywords

  • bronchiectasis
  • elderly
  • balance
  • cognitive ability
  • hand grip strength
  • hand functions
  • quality of life
  • lower extremity muscle strength
  • respiratory function parameters
  • reaction time
03

In context

Bronchiectasis

368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's enrollment of 30 is below the median of 160 across 132 observational studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Atlas University is the lead sponsor of 91 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Elderly with diagnosed with bronchiectasis and age matched healthy volunteers who do not have any diagnosed chronic diseases.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    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

Interventions

  • OtherCognitive skills test

    Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale.

    Also known as: MOCA

  • OtherReaction time test

    Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet.

    Also known as: 12-Red Square Test

  • OtherQuality of life assessment

    Quality of life assessment; It will be evaluated with the Nottingham Health Profile.

    Also known as: NIH

  • OtherLower extremity muscle strength assessment

    Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test.

    Also known as: 30-second sit-and-stand test

  • OtherHand grip strength measurement test

    Hand grip strength measurement test; It will be evaluated with a dynamometer.

    Also known as: dynamometer

  • OtherPulmonary function assessment

    Pulmonary function assessment; It will be evaluated by spirometry.

    Also known as: spirometry

  • OtherBalance assessment

    Balance assessment will be done with the Wii Fit Balance Board.

    Also known as: Wii Fit Balance Board

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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".

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

  6. 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)

    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.

07

Study locations

1 site
  • Istanbul Atlas University
    Istanbul, KAgıthane, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06606665
Lead sponsor
Atlas University
Responsible party
Hilal Denizoğlu Külli (Assoc. Prof., Atlas University) — Principal investigator
First posted
Sep 23, 2024
Start date
Oct 20, 2023
Primary completion
Apr 20, 2024
Completion
Jun 10, 2024
Last update
Feb 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion