NCT06383676

Brief Summary

The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

April 20, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 21, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1.5 years

First QC Date

April 21, 2024

Last Update Submit

December 23, 2024

Conditions

Keywords

balancereaction timefunctional capacity

Outcome Measures

Primary Outcomes (3)

  • The Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment (MoCA) is a brief instrument developed for the screening of milder forms of cognitive impairment. A score is derived by summing the points from each successfully completed task, for a total range from 0 to 30 points; higher scores indicate better cognitive performance. The MoCA was developed to screen milder forms of cognitive impairment through the assessment of a wide range of cognitive functions, such as short-term memory, executive functions, visuospatial abilities, language, attention, concentration, working memory, and temporal and spatial orientation. It comprises a 1-page test, which requires a short administration time (10-15 minutes).

    Eight weeks

  • Stroop Test

    The test consists of two cards, each containing 60 items, presented in six rows of 10 items. On the first card, there are small rectangles (0.5 x 1 cm) printed in red, green and blue. The second card contains names of the three colours (i.e., red, green and blue) printed in incongruent colours (e.g., the word 'red' is printed in blue ink). The Stroop test Çapa version consists of three parts: Stroop A, Stroop B and Stroop C. Stroop A. The first part of the test requires individuals to name the colours (i.e., red, green and blue) of the small rectangles as quickly as possible, following a sequence from left to right. If any sign of colour blindness or colour naming deficits is present, the test is discontinued. Stroop B. The second part of the test requires individuals to read as fast as possible the colour names (i.e., red, green, and blue) that are printed in incongruent ink colours. The Stroop test Çapa version consists of three parts: Stroop A, Stroop B and Stroop C. Stroop A. The

    Eight weeks

  • The Simple Reaction Time

    The simple reaction time is measured using an electronic timing system (including a digital display, a light, and a button, and the protocol that has been described in the literature was followed . Each older is seated so that the resting arm was on the table in a quiet environment. The testing side's second index is placed 1 cm away from the button of the device. Then, the participants are asked to press the button when the visual or auditory input appeared. A total of 10 repetitions are recorded, and the mean score of the last 5 tests is further analyzed .. The visual and auditory reaction time is randomly assigned. The reaction time is recorded with 1/1,000 seconds of sensitivity.

    Eight weeks

Secondary Outcomes (5)

  • The Four Square Step Test (FSST)

    Eight weeks

  • The short physical performance battery (SPPB)

    Eight weeks

  • Timed Up and Go Test (TUG)

    Eight weeks

  • Falls Efficacy Scale ( FES)

    Eight weeks

  • Mini-BESTest: Balance Evaluation Systems Test

    Eight weeks

Study Arms (2)

Functional balance based reaction exercise training.

EXPERIMENTAL

Functional balance-based balance reaction exercises will be integrated into functional balance exercises with the help of the BlazePod™ training device panel.

Other: Functional reaction balance training

Functional balance training

EXPERIMENTAL

The exercises will consist of functional balance activities, such as maintaining a standing posture, transitioning from sitting to standing, walking and balancing on one leg.

Other: Functional balance training

Interventions

The interventions will carried out two days a week and 40 minutes, for eight weeks.

Functional balance based reaction exercise training.

The interventions will carried out two days a week and 40 minutes, for eight weeks.

Functional balance training

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age of 65 or above
  • Minimum of 5 years of education
  • Moca score of 21 or higher
  • Capability to walk a minimum of 10 meters (with or without walking assistance if needed)

You may not qualify if:

  • Moca test score 21 and below
  • Having vision and hearing problems (which cannot be corrected with glasses or hearing aids)
  • Having an orthopedic or neurological disease that prevents standing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatma Kübra ÇEKOK

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Fatma Kübra ÇEKOK, Phd

    Tarsus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study participants are unaware of their assigned group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was planned as a randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.prof

Study Record Dates

First Submitted

April 21, 2024

First Posted

April 25, 2024

Study Start

April 20, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations