NCT07089667

Brief Summary

Virtual Reality exergame is a video games that combine body motion control with physical activity in a safe virtual environment. In the elderly, VR exergames like the Nintendo Switch RingFit Adventure aid rehabilitation, improving physical function, cognition, balance and mental well-being. These games overcome the boredom of traditional exercise with a multisensory and interactive environment that engages the whole body. The general objective of the present research is to evaluate the effectiveness of virtual reality exergames on physical activity and fitness in the elderly. Design : This study is an experimental study with a randomized controlled trial - double blind design. This experimental study was conducted with blinding, specifically a single blinding where the researcher and data analyst (statistician) did not know the allocation of samples to the intervention and control groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 7, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

Virtual Reality ExergameOlder AdultPhysical Activity

Outcome Measures

Primary Outcomes (7)

  • physical activity

    Physical activity was measured using the Indonesian version of the International Physical Activity Questionnaire (IPAQ) - Short Form. The International Physical Activity Questionnaire (IPAQ) score is calculated by assessing the duration and frequency of physical activities across three categories: walking, moderate-intensity, and vigorous-intensity activities. Each category is assigned a standard Metabolic Equivalent of Task (MET) value, namely 3.3 METs for walking, 4.0 METs for moderate activities, and 8.0 METs for vigorous activities. The weekly total MET-minutes are obtained by multiplying the MET value by the minutes per day and the number of days per week for each activity type, then summing these values across all categories. Based on the total MET-minutes per week, physical activity levels are interpreted : * Sedentary (\<600 MET-minutes/week) * Intermediate (600-3,000 MET-minutes/week) * Active (\>3,000 MET-minutes/week)

    Physical activity was assessed at week 0 (before the intervention) and week 6 (after the intervention) to evaluate changes in participants' physical activity levels during the intervention period.

  • body composition (muscle mass)

    The body composition (muscle mass) parameter is integratedly measured using Bioelectrical Impedance Analysis (BIA) with the Tanita BC 730 device. interpretation : Muscle mass, also presented as a percentage, reflects lean body mass important for function, with males aged 60-79 years ranging from 70-84% and females from 60-72.5%.

    Body composition (muscle mass) was assessed at week 0 (before the intervention) and week 6 (after the intervention) to evaluate changes in participants' body composition during the intervention period.

  • Hand muscle strength

    Hand muscle strength was measured using an electronic hand dynamometer, CAMRY ISO 9001 model EH101.

    Hand muscle strength was assessed at week 0 (before the intervention) and week 6 (after the intervention) to evaluate changes in participants' hand muscle strength during the intervention period.

  • Muscle endurance

    Muscle endurance was measured using the 30-second sit-to-stand test with a stopwatch

    Muscle endurance was assessed at week 0 (prior to the intervention) and week 6 (post-intervention) to evaluate changes in participants' muscle endurance throughout the intervention period.

  • Flexibility

    Flexibility was assessed using the Chair Sit-and-Reach Test.

    Flexibility was assessed at week 0 (prior to the intervention) and week 6 (post-intervention) to evaluate changes in participants' flexibility throughout the intervention period.

  • body composition (fat mass)

    The body composition (fat mass) parameter is integratedly measured using Bioelectrical Impedance Analysis (BIA) with the Tanita BC 730 device. Interpretation : Fat mass is expressed as a percentage of total body weight, varying by age and sex; for instance, males over 40 years typically range from 11-24%, while females range from 23-35%.

    Body composition (fat mass) was assessed at week 0 (before the intervention) and week 6 (after the intervention) to evaluate changes in participants' body composition during the intervention period.

  • Body composition (Bone mass)

    The body composition (bone mass) parameter is integratedly measured using Bioelectrical Impedance Analysis (BIA) with the Tanita BC 730 device. interpretation : Bone mass is reported in kilograms and stratified by weight and sex, such as 2.65-3.29 kg for males weighing 65-95 kg and about 2.40 kg for females weighing between 50-75 kg.

    Body composition (bone mass) was assessed at week 0 (before the intervention) and week 6 (after the intervention) to evaluate changes in participants' body composition during the intervention period.

Study Arms (2)

virtual reality exergame

EXPERIMENTAL

The Virtual Reality Exergame intervention involves physical exercise sessions using VR technology - the game Ring Fit Adventure, specifically designed for older adults. Participants begin with 10-minute exercise sessions, increasing by 5 minutes each week until reaching 30 minutes per session. The exercise frequency is three times per week, conducted over a 6-week period. The exercise prescription follows a protocol developed by the researchers. The training includes aerobic movements integrated into interactive games (types of games as specified in the protocol) that stimulate physical activity and motor coordination.

Behavioral: virtual reality exergame

Conventional-based aerobic exercise

ACTIVE COMPARATOR

The control group performs conventional aerobic exercise based on video aerobic exercise of the Ministry of Health (KEMENKES) protocol, with the same duration and frequency, to ensure an equivalent comparison in improving physical activity and fitness among older adults. Participants begin with 10-minute exercise sessions, increasing by 5 minutes each week until reaching 30 minutes per session. The exercise frequency is three times per week, conducted over a 6-week period. The exercise prescription follows a protocol developed by the researchers.

Behavioral: Conventional

Interventions

virtual reality exergame using Nintendo RingFit

virtual reality exergame
ConventionalBEHAVIORAL

Conventional-based aerobic exercise using video aerobic exercise of the Ministry of Health (KEMENKES) protocol

Conventional-based aerobic exercise

Eligibility Criteria

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

You may qualify if:

  • Willing to participate in the study
  • Aged above 60 years
  • Able to watch television with or without glasses from a distance of 2 meters (visual acuity between 20/20 and 20/80)
  • No cognitive impairment (MOCA-Ina score: 26-30)

You may not qualify if:

  • Congestive heart failure
  • Uncontrolled hypertension
  • History of fracture or surgery within the last 6 months
  • Currently on the waiting list for orthopedic surgery
  • Myocardial infarction or stroke within the last 6 months
  • Dependence on a wheelchair
  • Severe hearing and vision impairments
  • Other neuromusculoskeletal disorders that interfere with the ability to perform exercises (pain with VAS \> 4)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GPIB Jemaat Bukit Zaitun

Makassar, South Sulawesi, 90134, Indonesia

Location

Related Publications (30)

  • Riebe, D. (2018) ACSM's Guidelines for Exercise Testing and Prescription. Tenth, Wolters Kluwer. Tenth. Edited by J.K. Ehrman, G. Liguori, and M. Magal. philadelphia: Wolters Kluwer.

    BACKGROUND
  • Yeom HA, Jung D, Choi M. Adherence to Physical Activity Among Older Adults Using a Geographic Information System: Korean National Health and Nutrition Examinations Survey IV. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Jun;5(2):118-27. doi: 10.1016/S1976-1317(11)60020-0. Epub 2011 Jul 8.

    PMID: 25030261BACKGROUND
  • Matos-Duarte M, MartĂ­nez-de-Haro V, Sanz-Arribas I, Berlanga LA. Functional flexibility in institutionalized sedentary older adults. Rev Bras Cineantropom Desempenho Hum 2021, 23:e73816. DOI: http://doi.org/10.1590/19800037.2021v23e73816

    RESULT
  • Mologne MS, Hu J, Carrillo E, Gomez D, Yamamoto T, Lu S, Browne JD, Dolezal BA. The Efficacy of an Immersive Virtual Reality Exergame Incorporating an Adaptive Cable Resistance System on Fitness and Cardiometabolic Measures: A 12-Week Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Dec 23;20(1):210. doi: 10.3390/ijerph20010210.

  • Alcazar J, Alegre LM, Van Roie E, Magalhaes JP, Nielsen BR, Gonzalez-Gross M, Judice PB, Casajus JA, Delecluse C, Sardinha LB, Suetta C, Ara I. Relative sit-to-stand power: aging trajectories, functionally relevant cut-off points, and normative data in a large European cohort. J Cachexia Sarcopenia Muscle. 2021 Aug;12(4):921-932. doi: 10.1002/jcsm.12737. Epub 2021 Jul 3.

  • Munoz-Bermejo L, Adsuar JC, Mendoza-Munoz M, Barrios-Fernandez S, Garcia-Gordillo MA, Perez-Gomez J, Carlos-Vivas J. Test-Retest Reliability of Five Times Sit to Stand Test (FTSST) in Adults: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Jun 9;10(6):510. doi: 10.3390/biology10060510.

  • Feodoroff B, Konstantinidis I, Frobose I. Effects of Full Body Exergaming in Virtual Reality on Cardiovascular and Muscular Parameters: Cross-Sectional Experiment. JMIR Serious Games. 2019 Aug 28;7(3):e12324. doi: 10.2196/12324.

  • Jin, M.. (2023). EFFECTS OF AEROBIC EXERCISE ON BODY MORPHOLOGY IN OBESE UNIVERSITY STUDENTS. Revista Brasileira De Medicina Do Esporte, 29, e2022_0221. https://doi.org/10.1590/1517-8692202329012022_0221

    RESULT
  • Leiros-Rodriguez R, Soto-Rodriguez A, Perez-Ribao I, Garcia-Soidan JL. Comparisons of the Health Benefits of Strength Training, Aqua-Fitness, and Aerobic Exercise for the Elderly. Rehabil Res Pract. 2018 Jun 19;2018:5230971. doi: 10.1155/2018/5230971. eCollection 2018.

  • Nishi, N. , Tanaka, N. and Hirano, N. (2022) Characteristics of Body Composition and Relationship between Muscle Mass and Muscle Strength among Elderly Women in Different Age Groups. Advances in Aging Research, 11, 135-149. doi: 10.4236/aar.2022.115010.

    RESULT
  • Bai X, Soh KG, Omar Dev RD, Talib O, Xiao W, Soh KL, Ong SL, Zhao C, Galeru O, Casaru C. Aerobic Exercise Combination Intervention to Improve Physical Performance Among the Elderly: A Systematic Review. Front Physiol. 2022 Jan 4;12:798068. doi: 10.3389/fphys.2021.798068. eCollection 2021.

  • Rodriguez-Almagro D, Achalandabaso-Ochoa A, Ibanez-Vera AJ, Gongora-Rodriguez J, Rodriguez-Huguet M. Effectiveness of Virtual Reality Therapy on Balance and Gait in the Elderly: A Systematic Review. Healthcare (Basel). 2024 Jan 9;12(2):158. doi: 10.3390/healthcare12020158.

  • Naugle KE, Cervantes XA, Boone CL, Wind B, Naugle KM. Exploring actual and perceived levels of physical activity intensity during virtual reality active games. Front Sports Act Living. 2024 Feb 9;6:1349521. doi: 10.3389/fspor.2024.1349521. eCollection 2024.

  • Janeh O, Frundt O, Schonwald B, Gulberti A, Buhmann C, Gerloff C, Steinicke F, Potter-Nerger M. Gait Training in Virtual Reality: Short-Term Effects of Different Virtual Manipulation Techniques in Parkinson's Disease. Cells. 2019 May 6;8(5):419. doi: 10.3390/cells8050419.

  • Dore B, Gaudreault A, Everard G, Ayena JC, Abboud A, Robitaille N, Batcho CS. Acceptability, Feasibility, and Effectiveness of Immersive Virtual Technologies to Promote Exercise in Older Adults: A Systematic Review and Meta-Analysis. Sensors (Basel). 2023 Feb 24;23(5):2506. doi: 10.3390/s23052506.

  • Gao Z, Lee JE, McDonough DJ, Albers C. Virtual Reality Exercise as a Coping Strategy for Health and Wellness Promotion in Older Adults during the COVID-19 Pandemic. J Clin Med. 2020 Jun 25;9(6):1986. doi: 10.3390/jcm9061986.

  • Campo-Prieto P, Cancela-Carral JM, Rodriguez-Fuentes G. Feasibility and Effects of an Immersive Virtual Reality Exergame Program on Physical Functions in Institutionalized Older Adults: A Randomized Clinical Trial. Sensors (Basel). 2022 Sep 6;22(18):6742. doi: 10.3390/s22186742.

  • Kruse, L., Karaosmanoglu, S., Rings, S., Ellinger, B., & Steinicke, F. (2021). Enabling Immersive Exercise Activities for Older Adults: A Comparison of Virtual Reality Exergames and Traditional Video Exercises. Societies, 11(4), 134. https://doi.org/10.3390/soc11040134

    RESULT
  • Triangto K, Radi B, Siswanto BB, Tambunan TF, Heriansyah T, Harahap AR, Kekalih A, Katsukawa H, Santoso A. Non-dominant handgrip strength is associated with higher cardiorespiratory endurance and elevated NT-proBNP concentrations in ambulatory male adult outpatients with stable HFrEF. Narra J. 2024 Dec;4(3):e1278. doi: 10.52225/narra.v4i3.1278. Epub 2024 Nov 25.

  • Li M, Ogilvie H, Ochala J, Artemenko K, Iwamoto H, Yagi N, Bergquist J, Larsson L. Aberrant post-translational modifications compromise human myosin motor function in old age. Aging Cell. 2015 Apr;14(2):228-35. doi: 10.1111/acel.12307. Epub 2015 Feb 2.

  • Yang CM, Chen Hsieh JS, Chen YC, Yang SY, Lin HK. Effects of Kinect exergames on balance training among community older adults: A randomized controlled trial. Medicine (Baltimore). 2020 Jul 10;99(28):e21228. doi: 10.1097/MD.0000000000021228.

  • Tuan SH, Chang LH, Sun SF, Lin KL, Tsai YJ. Using exergame-based exercise to prevent and postpone the loss of muscle mass, muscle strength, cognition, and functional performance among elders in rural long-term care facilities: A protocol for a randomized controlled trial. Front Med (Lausanne). 2022 Dec 13;9:1071409. doi: 10.3389/fmed.2022.1071409. eCollection 2022.

  • Brady, N., McVeigh, J. G., McCreesh, K., Rio, E., Dekkers, T., & Lewis, J. S. (2021). Exploring the effectiveness of immersive Virtual Reality interventions in the management of musculoskeletal pain: a state-of-the-art review. Physical Therapy Reviews, 26(4), 262-275. https://doi.org/10.1080/10833196.2021.1903209

    RESULT
  • Maddison R, Foley L, Ni Mhurchu C, Jiang Y, Jull A, Prapavessis H, Hohepa M, Rodgers A. Effects of active video games on body composition: a randomized controlled trial. Am J Clin Nutr. 2011 Jul;94(1):156-63. doi: 10.3945/ajcn.110.009142. Epub 2011 May 11.

  • Karahan AY, Tok F, Taskin H, Kucuksarac S, Basaran A, Yildirim P. Effects of Exergames on Balance, Functional Mobility, and Quality of Life of Geriatrics Versus Home Exercise Programme: Randomized Controlled Study. Cent Eur J Public Health. 2015 Nov;23 Suppl:S14-8. doi: 10.21101/cejph.a4081.

  • Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and cognitive function in older adults. Psychol Aging. 2012 Sep;27(3):589-600. doi: 10.1037/a0026268. Epub 2011 Nov 28.

  • Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.

  • Shahana, A., Nair, U.S. and Hasrani, S.S. (2010) 'Effect of aerobic exercise programme on health related physical fitness components of middle aged women', British Journal of Sports Medicine, 44(Suppl_1), pp. i19-i19. Available at: https://doi.org/10.1136/bjsm.2010.078725.60.

    RESULT
  • Haley C, Andel R. Correlates of physical activity participation in community-dwelling older adults. J Aging Phys Act. 2010 Oct;18(4):375-89. doi: 10.1123/japa.18.4.375.

  • Lo YP, Chiang SL, Lin CH, Liu HC, Chiang LC. Effects of Individualized Aerobic Exercise Training on Physical Activity and Health-Related Physical Fitness among Middle-Aged and Older Adults with Multimorbidity: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Dec 25;18(1):101. doi: 10.3390/ijerph18010101.

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

ExergamingCongresses as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOrganizationsHealth Care Economics and Organizations

Study Officials

  • Andi Amirah Shaleha Junaedi, MD, M.Sc

    Physical Medicine and Rehabilitation, Faculty of Medicine of Hasanuddin University, Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In this study, masking is applied to both the investigators and the outcomes assessors to minimize bias during data collection and analysis. The investigators who analyze the data are blinded to the participants' group assignments to ensure objective interpretation of the results. The outcomes assessors, responsible for evaluating physical activity and fitness, are also blinded to which intervention each participant received, preventing subjective influence on outcome measurement.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The interventional study model in this research employs a parallel design, where participants are randomly assigned into two groups. One group receives the intervention in the form of Virtual Reality Exergame, while the other group serves as a control group receiving conventional aerobic exercise following the Ministry of Health. Both groups proceed simultaneously throughout the study period to compare the effects of the intervention on physical activity and fitness in older adults. This parallel model allows for a direct evaluation of the effectiveness of Virtual Reality Exergame by comparing outcomes between groups at the same time, resulting in more valid and reliable findings. Randomization is used to minimize bias and ensure equivalence between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 28, 2025

Study Start

June 21, 2024

Primary Completion

August 9, 2024

Study Completion

August 9, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

we plan to share all collected individual participant data (IPD) as well as all IPD that underlie the results reported in any publications arising from this study. This will ensure transparency and allow other researchers to verify, replicate, or build upon our findings.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The individual participant data (IPD) and accompanying supporting information will be made available starting 6 months after the publication of the main study results and will remain accessible for a period of 5 years. This timeframe allows sufficient time for initial data analysis and dissemination, while providing other researchers ample opportunity for secondary analysis and collaboration.
Access Criteria
Access to individual participant data (IPD) and supporting documentation will be granted to qualified researchers who submit a formal request outlining the purpose and proposed analyses. Data will be shared for purposes consistent with advancing scientific knowledge in the field of physical activity, virtual reality, aging. Requests will be reviewed by the principal investigator and a data access committee to ensure ethical use and participant confidentiality. Data will be shared through a secure data-sharing platform after signing a data use agreement to protect privacy and intellectual property

Available IPD Datasets

Study Protocol Access

Locations