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

February 25, 2025 updated by: Hilal Denizoğlu Külli, Atlas University

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • KAgıthane
      • Istanbul, KAgıthane, Turkey
        • Istanbul Atlas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

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.

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale.
Other Names:
  • MOCA
Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet.
Other Names:
  • 12-Red Square Test
Quality of life assessment; It will be evaluated with the Nottingham Health Profile.
Other Names:
  • NIH
Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test.
Other Names:
  • 30-second sit-and-stand test
Hand grip strength measurement test; It will be evaluated with a dynamometer.
Other Names:
  • dynamometer
Pulmonary function assessment; It will be evaluated by spirometry.
Other Names:
  • spirometry
Balance assessment will be done with the Wii Fit Balance Board.
Other Names:
  • Wii Fit Balance Board
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.

Cognitive skills; It will be evaluated with the Montreal Cognitive Assessment Scale.
Other Names:
  • MOCA
Reaction time; It will be evaluated with the 12-Red Square Test on the App-coo test application via tablet.
Other Names:
  • 12-Red Square Test
Quality of life assessment; It will be evaluated with the Nottingham Health Profile.
Other Names:
  • NIH
Lower extremity muscle strength assessment; It will be evaluated with a 30-second sit-and-stand test.
Other Names:
  • 30-second sit-and-stand test
Hand grip strength measurement test; It will be evaluated with a dynamometer.
Other Names:
  • dynamometer
Pulmonary function assessment; It will be evaluated by spirometry.
Other Names:
  • spirometry
Balance assessment will be done with the Wii Fit Balance Board.
Other Names:
  • Wii Fit Balance Board

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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".

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.
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.
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.

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.

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.
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.
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.
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.
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.
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)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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