NCT06400953

Brief Summary

The aim of the study is to evaluate the balance and dual-task activities of Kinetic Brain Exercises in healthy elderly individuals living in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

April 28, 2024

Last Update Submit

May 2, 2024

Conditions

Keywords

Kinetic Brain ExercisesBalanceDual Task PerformanceElderlyCore Stabilization

Outcome Measures

Primary Outcomes (8)

  • Demographic and Clinical Evaluation Form

    Name-surname, age, telephone number, gender, education level, height, weight, Body Mass Index (BMI), presence of chronic disease, regular medication use, whether or not they have a hobby, duration of stay in the nursing home, reason for staying in the nursing home and use of assistive walking devices were questioned.

    At baseline and after 8 weeks

  • Mini Mental State Test

    Cognitive status was evaluated.

    At baseline and after 8 weeks

  • Dual Task Performance Tests

    To evaluate dual-task activities, Timed Up and Go Test, 30-Second Sit-and-Go Test, Tandem Stance Test, 360° Rotation Test and One-Leg Stand Test were applied to individuals in three different ways: single task, cognitive task and motor task, and performance times were measured.

    At baseline and after 8 weeks

  • 10 Meter Walking Test

    It was used to evaluate individuals' walking speed.

    At baseline and after 8 weeks

  • Functional Reaching Test

    It was used to evaluate the balance performance of individuals.

    At baseline and after 8 weeks

  • Dual Task Survey

    It was used to obtain information about the difficulties individuals experience in daily life situations that require dual tasks.

    At baseline and after 8 weeks

  • Tinetti Fall Activity Scale

    It was used to assess individuals' fear of falling.Minimum score is 0 and maximum score is 28.

    At baseline and after 8 weeks

  • World Health Organization Quality of Life Scale Elderly Module

    It was used to evaluate the quality of life of the elderly. Minimum score is 0 and maximum score is 135.

    At baseline and after 8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Kinetic Brain Exercises and Core Stabilization Exercises were applied to Group 1

Other: Kinetic Brain Exercises and Core Stabilization ExercisesOther: Core Stabilization Exercises

Group 2

EXPERIMENTAL

Core Stabilization Exercises were applied to Group 2

Other: Core Stabilization Exercises

Interventions

Kinetic Brain Exercise Program Kinetic brain exercises were applied to Group 1 in groups of 8-10 people, 2 days a week for 40 minutes for 8 weeks.These exercises include warm-up, main and cool-down phases. Warm-up; These are coordination-oriented movements that include 'brain buttons', 'cross crawl' and 'the thinking cap' exercises. Main phase; These are exercises that include coordination, selective attention, audio-visual focus and balance, consisting of perceptual, independent and dependent movements. Cooling phase; It aims to ensure hand-eye coordination by consisting of double doodle, throwing balls to each other and lazy 8s exercises.Exercises were selected from the kinetic brain exercise pool, modified and applied for 2-8 weeks.The exercises were done while sitting and standing, with increasing difficulty levels. The factor that made the levels difficult was the time and complexity of the incoming command. A game ball with a diameter of 7 cm was used for the exercises.

Group 1

Core Stabilization Exercise Program in groups of 8-10 people, for 40 minutes, 2 days a week, for 8 weeks.These exercises included a 5-minute active warm-up, a 30-minute Core Stabilization exercise that included upper and lower extremity movements, and immediately followed by a 5-minute cool-down exercise.The exercises are pilates-based and in the first stage of the program. Movements were performed in standing and sitting positions.Movements were started with 6-8 repetitions, increased by 1-2 repetitions each week, and in the last week, 12-15 repetitions were performed, with contraction times increasing from 5 seconds to 10 seconds. As the exercises progressed from easy to difficult, from simple movements to complex movements, the movements were continued by adding an elastic band and 0.5 kg weight.While advancing the exercise program, the exercises were personalized by taking into account the individual's strain levels.

Group 1Group 2

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals living in nursing homes between the ages of 65-80,
  • Having signed the Informed Volunteer Consent Form,
  • Sufficient cognitive functions (Mini Mental State Test score being 24 and above)
  • Those who can stand independently on their own

You may not qualify if:

  • Those with neurological, musculoskeletal, inner ear or eye diseases that will cause impairment in vision or standing balance,
  • Those with moderate and severe congenital heart disease, coronary heart disease and cerebrovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 6, 2024

Study Start

December 15, 2023

Primary Completion

February 15, 2024

Study Completion

March 15, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations