NCT06606665

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

September 18, 2024

Last Update Submit

February 25, 2025

Conditions

Keywords

bronchiectasiselderlybalancecognitive abilityhand grip strengthhand functionsquality of lifelower extremity muscle strengthrespiratory function parametersreaction time

Outcome Measures

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.

    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.

    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

    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)

    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

    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 assessment will be administered only once to each participant. All tests will be performed on the same day and will take approximately 30 minutes.

  • +1 more secondary outcomes

Study Arms (2)

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 testOther: Reaction time testOther: Quality of life assessmentOther: Lower extremity muscle strength assessmentOther: Hand grip strength measurement testOther: Pulmonary function assessmentOther: 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 testOther: Reaction time testOther: Quality of life assessmentOther: Lower extremity muscle strength assessmentOther: Hand grip strength measurement testOther: Pulmonary function assessmentOther: Balance assessment

Interventions

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

Also known as: MOCA
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

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
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

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

Also known as: NIH
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

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
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

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

Also known as: dynamometer
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

Pulmonary function assessment; It will be evaluated by spirometry.

Also known as: spirometry
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

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

Also known as: Wii Fit Balance Board
elderly with bronchiectasis ( EXPERİMENTAL GROUP )healthy controls (CONTROL GROUP)

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, KAgıthane, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Muscle Strength Dynamometer

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 23, 2024

Study Start

October 20, 2023

Primary Completion

April 20, 2024

Study Completion

June 10, 2024

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations