Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-25 @ 11:03 PM
Study NCT ID:
NCT07045259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exergaming Program Versus Neuromuscular Exercise in Elderly People With Motor Cognitive Risk Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients who meet the inclusion criteria will be randomized into two treatment groups, structured exergaming and neuromuscular exercise training, 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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-06-20', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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).'}, {'measure': 'Stair Climbing Test (SCT)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': '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.'}, {'measure': 'Cognitive Officer TUG-SCT', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'In our research\n\n* Counting backwards from 50 by threes\n* 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).'}], 'secondaryOutcomes': [{'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': "Short Physical Performance Battery (SPPB) is a field test designed to evaluate the physical performance of elderly people, helps interpret their functional abilities, and gives an idea about the individual's biological age (Pavasini, 2016). SPPB, which is frequently used in elderly individuals in the literature, consists of the categories of static balance, 4-meter walking test, and 5-times sit-to-stand test (Corsonello, 2012 ). The balance test in SPPB includes three different postures: side-by-side, semi-tandem, and tandem. Each posture is held for up to 10 seconds. The ability to maintain these positions gives an idea about the individual's balance abilities (Cisternas, 2024). It is emphasized in the literature that the balance test, together with other components of SPPB, can predict all-cause mortality (Pahor, 2014). In our research, SPPB will be used to evaluate the static balance ability, walking speed, functional capacity,"}, {'measure': 'Dynamic Gait Index (DGI)', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The Dynamic Gait Index (DGI) is a widely accepted functional gait tool for assessing the risk of falls and functional stability while walking in the elderly (Shumway-Cook et al., 2013). In the literature, DGI is used as a valid, reliable, cheap and fast tool to assess the gait and balance of elderly individuals (Alghwiri, 2014). It consists of eight items including normal walking on level ground, walking with speed changes, walking with horizontal head movements, walking with vertical head movements, walking with pivot turns, walking by jumping over obstacles, taking steps around obstacles and climbing up and down stairs. Each item is rated on a 4-point scale ranging from 0 (severe impairment) to 3 (independent walking). The maximum total score can be 24. The scale, whose validity and reliability in Turkish in elderly individuals was conducted by Zirek, will be used to comprehensively assess walking in our study (Zirek, 2023).'}, {'measure': 'Muscle Strength Measurement', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Digital hand dynamometer is one of the tools used in muscle strength assessment and from which we can obtain objective data. It is noteworthy that digital hand dynamometer is frequently used to assess muscle strength in exercise studies conducted on elderly individuals (Fuchs, 2024). The measurement begins by placing the electronic and/or mechanical sensors perpendicular to the pivot point of the extremity to be tested. The measurement is made by having the tested person exert maximum effort against the device during the measurement and the tester responding to this effort with maximum force in the opposite direction in order to prevent movement (Garcia, 2020). Each measurement will be repeated twice for the right and left extremities and the results obtained will be recorded in pounds (Ib).'}, {'measure': 'Reaction speed assessment', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Reaction speed is the time between the stimulus reaching the central nervous system, its evaluation and the appropriate response after the relevant arrangements are made (Davranche, 2006). With aging, the capacity of the nervous system to process information and activate a response decreases. These factors affect the quality of life of older adults and reduce their active participation. In our research, the Light Trainer Flash Light Exercise System, Reaction X device used in the literature for reaction speed assessment will be used (Erdoğanoğlu, 2024). The reaction time of the dominant hand and free hand will be recorded and the accuracy percentage will be calculated by video analysis of the test performance.'}, {'measure': 'Performance-Oriented Mobility Assessment', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The Performance-Oriented Mobility Assessment (POMA), introduced to the literature by Tinetti in 1986, is frequently used to assess balance and gait in elderly individuals and to assess the risk of falls in individuals with conditions affecting balance and gait (Tinetti, 1986). POMA, whose Turkish validity and reliability were conducted by Ağırcan, will be used in our research for the comprehensive assessment of gait and balance (Ağırcan, 2009). Permissions from the authors are provided as an attachment.'}, {'measure': 'Berg Balance Assessment', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'Berg Balance Test (BBS), one of the frequently used tests in balance assessment in elderly individuals, has a test-retest reliability with an ICC (Intraclass Correlation Coefficient) of 0.91 and high inter-rater reliability with an ICC of 0.97 (Neuls, 2011). BBS, which consists of 14 different tasks or activities, is scored from 0 to 4 for tasks such as sitting to standing, standing without support, sitting without support, etc. The total score varies between 0 and 56, with a high score being interpreted as better balance. The scale, which was validated in Turkish by Şahin and colleagues, shows a high risk of falling, a score of 0 to 20 indicates a moderate risk of falling, a score of 21 to 40 indicates a moderate risk of falling, and a score of 41 to 56 indicates a low risk of falling (Sahin, 2008).'}, {'measure': 'Physical Activity Enjoyment Scale', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks', 'description': 'The Physical Activity Enjoyment Scale is one of the scales used to measure enjoyment in physical activity. The test-retest reliability of the scale was reported to be 0.69, showing strong internal consistency and reliability (Weyland et al., 2024). The Turkish validity and reliability of the scale, which consists of 8 items and a single dimension, was conducted by Özkurt et al. in 2022, and it was reported that the Turkish form can be used as a valid and reliable measurement tool (Özkurt, 2022).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motoric Cognitive Risk Syndrome', 'Elderly', 'neuromuscular exercise', 'exergaming'], 'conditions': ['Motoric Cognitive Risk Syndrome', 'Elderly (People Aged 65 or More)', 'Geriatric Patient']}, 'referencesModule': {'references': [{'pmid': '16406344', 'type': 'BACKGROUND', 'citation': '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': '31740163', 'type': 'BACKGROUND', 'citation': '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': '36121068', 'type': 'BACKGROUND', 'citation': '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': '24710977', 'type': 'BACKGROUND', 'citation': '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': '24866862', 'type': 'BACKGROUND', 'citation': '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': '22004280', 'type': 'BACKGROUND', 'citation': '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': '28003033', 'type': 'BACKGROUND', 'citation': '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': '37228826', 'type': 'BACKGROUND', 'citation': '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': '33807414', 'type': 'BACKGROUND', 'citation': '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': '37426725', 'type': 'BACKGROUND', 'citation': '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': '40407569', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being over 65 years of age\n* Having a Barthel Daily Living Activities Index score of ≥ 90\n* Having a Mini Mental Status Score (MMSE) of ≥24\n* Having the ability to walk with or without a walking aid\n* Having a slow walking speed\n* Having subjective memory complaints\n\nExclusion Criteria:\n\n* Presence of Dementia\n* Major Depression\n* Generalized Anxiety Disorder and Delirium\n* Parkinson's Disease\n* Anemia\n* Thyroid Disease\n* Vitamin B12 Deficiency\n* Malnutrition\n* Terminal Illness\n* Hearing or Visual Impairment"}, 'identificationModule': {'nctId': 'NCT07045259', 'briefTitle': 'Effect of Exergaming Program Versus Neuromuscular Exercise in Elderly People With Motor Cognitive Risk Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Effect of Exergaming Program Versus Neuromuscular Exercise on Locomotor and Cognitive Functions in Elderly People With Motor Cognitive Risk Syndrome', 'orgStudyIdInfo': {'id': '2025/176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'The Neuromuscular Exercise Group', 'interventionNames': ['Other: Exergaming Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exergaming Group', 'interventionNames': ['Other: The Neuromuscular Exercise Training program']}], 'interventions': [{'name': 'The Neuromuscular Exercise Training program', 'type': 'OTHER', 'description': 'The Neuromuscular Exercise Training program will be carried out in groups of 5 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.', 'armGroupLabels': ['Exergaming Group']}, {'name': 'Exergaming Exercise Training', 'type': 'OTHER', 'description': 'In our study, Xbox 360 Kinect game console and Kinect sensor will be used within the scope of Exergaming. Exergaming program will be carried out in groups of 5 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. Just Dance, a movement-based dance/rhythm game accompanied by dance choreography, will be preferred in the warm-up phase. In the loading phase, games such as Reflex Ridge, River Rush, Ralleyball from Microsoft Kinect Adventures game series for lower extremity functions; Bowling, Table Tennis, Swim Out, Fruit Ninja from Microsoft Kinect Sports game series for upper extremity functions will be included. As the sessions progress, game levels will be gradually made more difficult, progressing from easy to difficult.', 'armGroupLabels': ['The Neuromuscular Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'GULFİDAN TOKGÖZ, Lecturer, PhD (c)', 'role': 'CONTACT', 'email': 'gulfidan.tokgoz@gmail.com', 'phone': '+90552 022 76 32'}, {'name': 'Saime Nilay ARMAN, Assoc. Prof. Dr.', 'role': 'CONTACT', 'email': 'saimenilayarman@istanbul.edu.tr', 'phone': '+90553 455 87 07'}], 'overallOfficials': [{'name': 'Gulfidan TOKGÖZ, Lecturer, PhD (c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İstanbul University-Cerrahpasa'}, {'name': 'Saime Nilay ARMAN, Assoc. Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'İstanbul University-Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'İstanbul Üniversitesi-Cerrahpasa', 'investigatorFullName': 'Gulfidan Tokgoz', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}