NCT07045259

Brief Summary

The primary aim of our study is to compare the effects of neuromuscular exercise training versus structured exergaming program on locomotor and cognitive functions in elderly individuals with Motor Cognitive Risk (MCR), which defines the transition state between typical aging and dementia and mild cognitive impairment. This study aims to present for the first time the effects of neuromuscular exercise training and exergaming program on locomotor and cognitive functions in elderly individuals with MCR with comparative results.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

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 Progress71%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

June 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

June 20, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

Motoric Cognitive Risk SyndromeElderlyneuromuscular exerciseexergaming

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go Test (TUG)

    TUG test is a frequently used field test to evaluate mobility, balance, fall risk and walking in elderly individuals (Magda,2024; (Racha, 2023). The test involves the individual getting up from a chair, walking 3 meters, turning, and sitting. The time taken to complete this series of movements is measured and recorded using a stopwatch (Racha, 2023).

    From enrollment to the end of treatment at 8 weeks

  • Stair Climbing Test (SCT)

    The stair climbing test is frequently used in the evaluation of locomotor functions in elderly individuals. The validity and reliability of the STAIR, which has been investigated in elderly people with knee osteoarthritis, has been reported to have a test-retest reliability coefficient of 0.93 and high reliability (Jose, 2021). In our study, they will be asked to ascend and descend 4 steps, each of which is 50 cm wide, 15 cm high and 25 cm deep, as quickly but safely as possible. They will be able to use the handrails when they need to while ascending or descending the stairs, and the total time taken to complete the task will be measured in seconds with a stopwatch.

    From enrollment to the end of treatment at 8 weeks

  • Cognitive Officer TUG-SCT

    In our research * Counting backwards from 50 by threes * Cognitive officer TUG and SCT tests will be conducted to answer the questions prepared by the researchers as yes if red and no if blue, and the results will be recorded in terms of time (Li, 2023).

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (7)

  • Short Physical Performance Battery (SPPB)

    From enrollment to the end of treatment at 8 weeks

  • Dynamic Gait Index (DGI)

    From enrollment to the end of treatment at 8 weeks

  • Reaction speed assessment

    From enrollment to the end of treatment at 8 weeks

  • Performance-Oriented Mobility Assessment

    From enrollment to the end of treatment at 8 weeks

  • Berg Balance Assessment

    From enrollment to the end of treatment at 8 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Satisfaction Level

    From enrollment to the end of treatment at 8 weeks

Study Arms (3)

The Neuromuscular Exercise Group

ACTIVE COMPARATOR
Other: Exergaming Exercise Training

Exergaming Group

ACTIVE COMPARATOR
Other: The Neuromuscular Exercise Training program

Control Group

NO INTERVENTION

Interventions

The Neuromuscular Exercise Training program will be carried out in groups of 2 people for 45 minutes/2 days/8 weeks. The exercise program will consist of warm-up, loading and cooling phases. The warm-up phase will consist of flexibility exercises, mini squat and roll down etc. exercises to prepare the individual for exercise. The loading phase will consist of a cognitive-based neuromuscular exercise program aiming to provide stabilization, increase in balance, neuroplasticity and motor control and is planned to include strengthening exercises, stabilization exercises, balance-proprioceptive exercises and neuromuscular control exercise training with visual feedback. The exercises will progress gradually from easy to difficult with increasing repetition and set numbers.

Exergaming Group

In our study, Xbox One Kinect game console and Kinect sensor will be used within the scope of Exergaming. Exergaming program will be carried out in groups of 2 people for 45 minutes/ 2 days/ 8 weeks. It will consist of warm-up, loading and cooling phases. The games to be used for the Exergaming program were selected from games that include locomotor and cognitive repetitive tasks. The selected exergames involve repetitive locomotor and cognitive tasks. Piano step will be utilized during the warm-up for its rhythm-based movement patterns. For the conditioning phase, lower extremity exercises will include Reflex Ridge, River Rush, and Rallyball (Kinect Adventures), while upper extremity exercises will consist of Bowling, Table Tennis, Swimming (Kinect Sports), and Fruit Ninja. A progressive training approach will be followed, with game difficulty levels increasing incrementally as the sessions advance.

The Neuromuscular Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Being over 65 years of age
  • Having a Barthel Daily Living Activities Index score of ≥ 90
  • Having a Mini Mental Status Score (MMSE) of ≥24
  • Having the ability to walk with or without a walking aid
  • Having a slow walking speed
  • Having subjective memory complaints

You may not qualify if:

  • Presence of Dementia
  • Major Depression
  • Generalized Anxiety Disorder and Delirium
  • Parkinson's Disease
  • Anemia
  • Thyroid Disease
  • Vitamin B12 Deficiency
  • Malnutrition
  • Terminal Illness
  • Hearing or Visual Impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balıkesir Üniversitesi

Balıkesir, Turkey (Türkiye)

RECRUITING

Related Publications (11)

  • Davranche K, Burle B, Audiffren M, Hasbroucq T. Physical exercise facilitates motor processes in simple reaction time performance: an electromyographic analysis. Neurosci Lett. 2006 Mar 20;396(1):54-6. doi: 10.1016/j.neulet.2005.11.008. Epub 2006 Jan 10.

    PMID: 16406344BACKGROUND
  • Garcia MAC, Souza VH. The (un)standardized use of handheld dynamometers on the evaluation of muscle force output. Braz J Phys Ther. 2020 Jan-Feb;24(1):88-89. doi: 10.1016/j.bjpt.2019.10.004. Epub 2019 Nov 13. No abstract available.

    PMID: 31740163BACKGROUND
  • Zirek E, Mustafaoglu R, Cicek A, Ahmed I, Mavromoustakos S. Reliability and Validity of the Turkish Version of the Modified Dynamic Gait Index in the Elderly. Eval Health Prof. 2023 Jun;46(2):135-139. doi: 10.1177/01632787221128311. Epub 2022 Sep 17.

    PMID: 36121068BACKGROUND
  • Alghwiri AA. Reliability and validity of the Arabic Dynamic Gait Index in people poststroke. Top Stroke Rehabil. 2014 Mar-Apr;21(2):173-9. doi: 10.1310/tsr2102-173.

    PMID: 24710977BACKGROUND
  • Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.

    PMID: 24866862BACKGROUND
  • Corsonello A, Lattanzio F, Pedone C, Garasto S, Laino I, Bustacchini S, Pranno L, Mazzei B, Passarino G, Incalzi RA; Pharmacosurveillance In The Elderly Care Pvc Study Investigators. Prognostic significance of the short physical performance battery in older patients discharged from acute care hospitals. Rejuvenation Res. 2012 Feb;15(1):41-8. doi: 10.1089/rej.2011.1215. Epub 2011 Oct 17.

    PMID: 22004280BACKGROUND
  • Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.

    PMID: 28003033BACKGROUND
  • Li Y, Yu N, Zhang C, Song Q, Wang J, Sun W. Test-retest reliability of kinematic and kinetic parameters during dual-task stair walking in the elderly. Front Physiol. 2023 May 9;14:1177159. doi: 10.3389/fphys.2023.1177159. eCollection 2023.

    PMID: 37228826BACKGROUND
  • Casana J, Calatayud J, Silvestre A, Sanchez-Frutos J, Andersen LL, Jakobsen MD, Ezzatvar Y, Alakhdar Y. Knee Extensor Muscle Strength Is More Important Than Postural Balance for Stair-Climbing Ability in Elderly Patients with Severe Knee Osteoarthritis. Int J Environ Res Public Health. 2021 Mar 31;18(7):3637. doi: 10.3390/ijerph18073637.

    PMID: 33807414BACKGROUND
  • Soubra R, Mourad-Chehade F, Chkeir A. Automation of the Timed Up and Go Test Using a Doppler Radar System for Gait and Balance Analysis in Elderly People. J Healthc Eng. 2023 Jun 29;2023:2016262. doi: 10.1155/2023/2016262. eCollection 2023.

    PMID: 37426725BACKGROUND
  • Reis M, Teixeira M, Carvao C, Martins AC. Validity and Reliability of the Self-Administered Timed Up and Go Test in Assessing Fall Risk in Community-Dwelling Older Adults. Geriatrics (Basel). 2025 Apr 29;10(3):62. doi: 10.3390/geriatrics10030062.

    PMID: 40407569BACKGROUND

Study Officials

  • Gulfidan TOKGÖZ, Lecturer, PhD (c)

    İstanbul University-Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Saime Nilay ARMAN, Assoc. Prof. Dr.

    İstanbul University-Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

GULFİDAN TOKGÖZ, Lecturer, PhD (c)

CONTACT

Saime Nilay ARMAN, Assoc. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients who meet the inclusion criteria will be randomized into three treatment groups, structured exergaming and neuromuscular exercise training and control group with a 1:1 block allocation. Randomization will be performed by a researcher not involved in the study using a website (www.randomization.com). Interventions and assessments will be administered by physiotherapists. After the end of treatment, both groups will be re-evaluated using the same procedures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
İstanbul Üniversitesi-Cerrahpasa

Study Record Dates

First Submitted

June 20, 2025

First Posted

July 1, 2025

Study Start

December 25, 2025

Primary Completion

March 25, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations