NCT07070336

Brief Summary

Objective: The aim of this protocol study was to investigate the effect of neuroathletic exercise on walking speed, fall risk and cognitive function in the elderly. Method: The study is planned as a single-centre, double-blind, parallel group randomised controlled experimental design and will be conducted in accordance with SPIRIT. The sample of the study will consist of healthy elderly people aged 60-80 years. In order to ensure parametric conditions, the sample will be divided into two groups as experimental group (n=30) in which neuroathletic exercise will be performed and control group (n=30) in which Turkey Physical Activity Guidelines will be given and a total of 60 elderly people will be randomly assigned to the groups. The elderly assigned to the experimental and control groups according to the order of randomisation will be administered the timed up and go test (TUG), short physical performance battery (SPPB), geriatric depression scale (GDÖ), MoCA test as pre-test and post-test. The experimental group will be asked to perform neuroathletic exercises two days a week for 12 weeks under the supervision of a physiotherapist, and will be asked to perform a home exercise programme one day a week. The control group will be given the Turkish Physical Activity guide. Data will be collected by the researcher. Results: Considering the limited number of studies on the use of neuroathletic exercises in the literature, it is thought that our randomised controlled study designed to determine the effect of neuroathletic exercise on walking speed, fall risk and cognitive functions in the elderly will contribute to the literature.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 1, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 4, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

May 26, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

agingneuroathletic exercisewalking speedgait speedfall riskcognitive function

Outcome Measures

Primary Outcomes (3)

  • Walking speed

    • 4-Meter Walking Speed Test: Allows the calculation of walking speed according to the time the participant walks 4 meters on a flat surface. It is a reliable scale widely used to predict mobility and fall risk in elderly individuals (Mehmet et al., 2020)

    12 week

  • Fall risk

    • Time Up and Go (TUG) Test: It evaluates the functional mobility level and fall risk by measuring the time it takes for the participant to get up from the chair and walk 3 meters, turn around, come back and sit down again in seconds (Podsiadlo et al., 1991).

    12 week

  • Cognitive function

    • Montreal Cognitive Assessment Scale (MoCA): It is a valid and reliable scale that evaluates the participants' performance in cognitive areas such as executive functions, attention, memory, language, and visual-spatial skills. The total score is evaluated out of 30, and scores of 26 and above are considered normal cognitive levels (Nasreddine et al., 1991).

    12 week

Study Arms (2)

Neuroathletic exercise group

EXPERIMENTAL

After warm-up and reset exercises, eye muscle training will begin with a star chart. Then, it consists of exercises that regulate the accommodation reflex, balance the right and left lobes, regulate the vestibular system, and rhythm exercises. After explaining the purpose of the study to the individuals who will be given exercises according to the randomization order, the first measurements will be taken and the exercises will begin. At the end of the 12th week, the measurements will be taken again and the effectiveness of the exercises will be evaluated. The exercises will be done with a physiotherapist 2 days a week, and will be given as a home exercise program for 1 day.

Other: Neuroathletic exercise

Control Group

NO INTERVENTION

Within the scope of the research, after the purpose of the study is explained to the individuals in this group, pre-tests will be conducted according to the randomization order. The individuals in this group will be given the 'Physical Activity in the Elderly' section of the Turkish Physical Activity Guide.

Interventions

After warm-up and resetting exercises, it will start with eye muscle training with a star chart. It then consists of exercises that regulate the accommodation reflex, balance the right and left lobes, regulate the vestibular system and rhythm exercises.

Neuroathletic exercise group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages between 60-80
  • Volunteering to participate in the study
  • Having the ability to perform physical, cognitive and sensory tests and exercises

You may not qualify if:

  • Having a history of injury to the lower and upper extremities within the last year
  • Having regular physical activity or sports habits.
  • Having participated in any physical activity program in the last 6 months
  • Having a sensory pathology that prevents participation in the study
  • Having any musculoskeletal, neurological, respiratory or cardiovascular pathology that will limit exercise
  • Having a history of malignant disease
  • Having an eye defect that cannot be corrected with lenses, such as cataracts, that prevents tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Evers J, Stolz I, Klein M. Neuroathletic training in stroke rehabilitation? A single-blind randomized controlled pilot study on the potential of neuroathletic training for balance ability in stroke outpatient rehabilitation. BMC Res Notes. 2024 Dec 12;17(1):358. doi: 10.1186/s13104-024-07022-0.

    PMID: 39668364BACKGROUND
  • Lienhard, L., Schmid-Fetzer, U., & Cobb, E. (2019). Neuronale Heilung: Mit einfachen Übungen den Vagusnerv aktivieren-gegen Stress, Depressionen, Ängste, Schmerzen und Verdauungsprobleme. Riva Verlag.

    BACKGROUND
  • Broglio SP, Register-Mihalik JK, Guskiewicz KM, Leddy JJ, Merriman A, Valovich McLeod TC. National Athletic Trainers' Association Bridge Statement: Management of Sport-Related Concussion. J Athl Train. 2024 Mar 1;59(3):225-242. doi: 10.4085/1062-6050-0046.22.

    PMID: 38530653BACKGROUND

Related Links

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study consists of an experimental and control group. After the pre-tests are applied to the individuals in the experimental groups, neuroathletic exercises will be performed 3 days a week for 12 weeks. Exercises will be performed with the help of a physiotherapist at the KTO Karatay University laboratory 2 days a week, and they will be asked to do it as a home program 1 day a week. At the end of 12 weeks, the final test will be applied and evaluated. The preliminary tests of the control panel are organized as the Activity in the Elderly section of the Activity Guide in Türkiye. During this process, confirmation is collected by frequently calling whether they do any activity outside of their daily routine activities. At the end of 12 weeks, the final test will be applied and the results will be supported with the exercise group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2025

First Posted

July 17, 2025

Study Start

May 1, 2025

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

September 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

It is planned to write a report and article with the data of the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2 year

Locations