Healthy ElderlyNCT07089667
The Effect of Virtual Reality Exergame on Physical Activity and Fitness in The Elderly
A study testing virtual reality exergame and Conventional in people with Healthy Elderly, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly
- What is being tested?
- virtual reality exergame and Conventional
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jun 2024to 9 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Aging is associated with a decline in biological, physiological, and functional capacities, impacting muscle strength, flexibility, balance, and the ability to perform daily activities. This decline adversely affects the quality of life in the elderly, measurable through the concept of healthy adjusted life expectancy (HALE). In Indonesia, the average HALE is 62.25 years, indicating a loss of approximately 8.85 years due to chronic diseases and disabilities.
One effective strategy to address chronic diseases and disabilities is the implementation of physical activities or exercises, including aerobic, strength, flexibility, and balance training, as recommended by the World Health Organization (WHO). Aerobic exercise not only enhances cardiovascular and pulmonary function but also provides broader benefits to both physical and mental health. However, adherence and motivation in elderly populations are often low due to external factors such as limited mobility and unsupportive environments.
To overcome these challenges, exergames have emerged as an innovative intervention combining active video gaming with physical exercise. Virtual Reality (VR) exergames, such as the Nintendo Switch RingFit Adventure, offer immersive, multisensory, and interactive environments that enhance motivation for exercise among older adults. Evidence suggests that VR exergame interventions can improve physical function, reduce symptoms of depression and anxiety, and enhance health-related quality of life, although research on fitness outcomes in the elderly remains limited and warrants further investigation.
The general objective : to evaluate the effectiveness of virtual reality exergames on physical activity and fitness in the elderly.
Specific objectives:
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on physical activity in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on body composition parameters in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on hand muscle strength parameters in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on muscle endurance in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on flexibility in the older adult.
Methods : This study is an experimental study with a randomized controlled trial - double blind design. The study sample consisted of 40 patients assigned to the intervention group (n=20) or control group (n=20). The study will be conducted from February 2024 to June 2024, targeting the elderly population in Makassar City, South Sulawesi, Indonesia. The accessible population consists of elderly individuals in the Zaitun Elderly Community.
Researcher will compare the intervention group, which participates in virtual reality exergame-based aerobic exercise, with the control group, which engages in video-based aerobic exercise provided by the Ministry of Health, focusing on physical activity and physical fitness outcomes.
- Participants will undergo interviews, physical examinations (vital signs, nutritional status, weight, height, and BMI), and additional assessments before and after 6 weeks of exercise, including :
- IPAQ (International Physical Activity Questionnaire) for daily activity, muscle endurance (30-second sit-to-stand test), hand strength (dynamometer), flexibility (chair-sit-and-reach test), and body composition (bioimpedance analysis).
- Cognitive function (MOCA-Ina), exercise intensity (Borg Scale), and pre-exercise protocols (risk screening, 6-minute walking test) on the first day, followed by an introduction to equipment and exercise clothing.
- Both groups will follow a warm-up and cool-down routine for 10 minutes before and after exercise. The treatment group will perform VR exergame exercises using Nintendo Switch Ring Fit Adventure 3 times per week for 6 weeks, while the control group will perform conventional aerobic exercises supervised by a doctor.
- Exercise adherence and intensity will be monitored and recorded in a logbook, along with any complaints before, during, and after each session. The estimated time required for each meeting (training session) will increase every week by 40 - 60 minutes.
- At the end of the study, data will be collected again, and any adverse event (AE) experienced by participants will be addressed. Researcher will pause exercises and treat them if symptoms such as cybersickness occur.
Ethical Approval and Sample Criteria This study has obtained ethical approval from the Ethics Committee of the Faculty of Medicine, Hasanuddin University, Makassar, Indonesia, to ensure the quality and compliance of the research.
The data collected will undergo descriptive analysis to outline the characteristics of the participants. For hypothesis testing, chi-square or McNemar tests will be used for categorical dependent variables, while t-tests will analyze numerical dependent variables. The effects of VR exergame compared to aerobic exercise will be assessed using independent t-tests for normally distributed data and Mann-Whitney tests for non-normal data. Normality and homogeneity of numerical dependent variables will be evaluated using the Kolmogorov-Smirnov test, with p-values greater than 0.05 indicating normal distribution. Results will be comprehensively discussed by the research team and experts to draw appropriate conclusions. Correlation between variables will be measured using Pearson's correlation for normally distributed numerical data, Spearman's test for ordinal categorical data, or contingency coefficients for nominal categorical data. All analyses will be conducted using SPSS version 23.
- Conditions
- Healthy Elderly
- Being tested
- virtual reality exergame, Conventional
- Keywords
- Virtual Reality Exergame, Older Adult, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality exergameBehavioural
virtual reality exergame using Nintendo RingFit
ConventionalBehavioural
Conventional-based aerobic exercise using video aerobic exercise of the Ministry of Health (KEMENKES) protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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%.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start21 Jun 2024
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Healthy ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Amirah Shaleha Junaedi, Hasanuddin University
- Investigators
- Andi Amirah Shaleha Junaedi, MD, M.Sc, Principal investigator, Physical Medicine and Rehabilitation, Faculty of Medicine of Hasanuddin University, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089667
- Sponsor's protocol ID
- UH24010039
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
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.
PubMed 25030261Matos-Duarte M, Martínez-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
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.
PubMed 36612530Alcazar 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.
PubMed 34216098Munoz-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.
PubMed 34207604Feodoroff 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.
PubMed 31464194Jin, 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
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.
PubMed 30018825Nishi, 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.
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.
PubMed 35058805Rodriguez-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.
PubMed 38255047Naugle 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.
PubMed 38406766Janeh 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.
PubMed 31064145Dore 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.
PubMed 36904709
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Exergame on Physical Activity and Fitness in The Elderly
- ClinicalTrials.gov ID
- NCT07089667
- Acronym / sponsor ID
- UH24010039
- Conditions
- Healthy Elderly
- Keywords
- Virtual Reality Exergame, Older Adult, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aging is associated with a decline in biological, physiological, and functional capacities, impacting muscle strength, flexibility, balance, and the ability to perform daily activities. This decline adversely affects the quality of life in the elderly, measurable through the concept of healthy adjusted life expectancy (HALE). In Indonesia, the average HALE is 62.25 years, indicating a loss of approximately 8.85 years due to chronic diseases and disabilities.
One effective strategy to address chronic diseases and disabilities is the implementation of physical activities or exercises, including aerobic, strength, flexibility, and balance training, as recommended by the World Health Organization (WHO). Aerobic exercise not only enhances cardiovascular and pulmonary function but also provides broader benefits to both physical and mental health. However, adherence and motivation in elderly populations are often low due to external factors such as limited mobility and unsupportive environments.
To overcome these challenges, exergames have emerged as an innovative intervention combining active video gaming with physical exercise. Virtual Reality (VR) exergames, such as the Nintendo Switch RingFit Adventure, offer immersive, multisensory, and interactive environments that enhance motivation for exercise among older adults. Evidence suggests that VR exergame interventions can improve physical function, reduce symptoms of depression and anxiety, and enhance health-related quality of life, although research on fitness outcomes in the elderly remains limited and warrants further investigation.
The general objective : to evaluate the effectiveness of virtual reality exergames on physical activity and fitness in the elderly.
Specific objectives:
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on physical activity in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on body composition parameters in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on hand muscle strength parameters in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on muscle endurance in the older adult.
- To determine the difference in effectiveness between virtual reality exergame and aerobic exercise training on flexibility in the older adult.
Methods : This study is an experimental study with a randomized controlled trial - double blind design. The study sample consisted of 40 patients assigned to the intervention group (n=20) or control group (n=20). The study will be conducted from February 2024 to June 2024, targeting the elderly population in Makassar City, South Sulawesi, Indonesia. The accessible population consists of elderly individuals in the Zaitun Elderly Community.
Researcher will compare the intervention group, which participates in virtual reality exergame-based aerobic exercise, with the control group, which engages in video-based aerobic exercise provided by the Ministry of Health, focusing on physical activity and physical fitness outcomes.
- Participants will undergo interviews, physical examinations (vital signs, nutritional status, weight, height, and BMI), and additional assessments before and after 6 weeks of exercise, including :
- IPAQ (International Physical Activity Questionnaire) for daily activity, muscle endurance (30-second sit-to-stand test), hand strength (dynamometer), flexibility (chair-sit-and-reach test), and body composition (bioimpedance analysis).
- Cognitive function (MOCA-Ina), exercise intensity (Borg Scale), and pre-exercise protocols (risk screening, 6-minute walking test) on the first day, followed by an introduction to equipment and exercise clothing.
- Both groups will follow a warm-up and cool-down routine for 10 minutes before and after exercise. The treatment group will perform VR exergame exercises using Nintendo Switch Ring Fit Adventure 3 times per week for 6 weeks, while the control group will perform conventional aerobic exercises supervised by a doctor.
- Exercise adherence and intensity will be monitored and recorded in a logbook, along with any complaints before, during, and after each session. The estimated time required for each meeting (training session) will increase every week by 40 - 60 minutes.
- At the end of the study, data will be collected again, and any adverse event (AE) experienced by participants will be addressed. Researcher will pause exercises and treat them if symptoms such as cybersickness occur.
Ethical Approval and Sample Criteria This study has obtained ethical approval from the Ethics Committee of the Faculty of Medicine, Hasanuddin University, Makassar, Indonesia, to ensure the quality and compliance of the research.
The data collected will undergo descriptive analysis to outline the characteristics of the participants. For hypothesis testing, chi-square or McNemar tests will be used for categorical dependent variables, while t-tests will analyze numerical dependent variables. The effects of VR exergame compared to aerobic exercise will be assessed using independent t-tests for normally distributed data and Mann-Whitney tests for non-normal data. Normality and homogeneity of numerical dependent variables will be evaluated using the Kolmogorov-Smirnov test, with p-values greater than 0.05 indicating normal distribution. Results will be comprehensively discussed by the research team and experts to draw appropriate conclusions. Correlation between variables will be measured using Pearson's correlation for normally distributed numerical data, Spearman's test for ordinal categorical data, or contingency coefficients for nominal categorical data. All analyses will be conducted using SPSS version 23.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| virtual reality exergame | Experimental | Behavioral: virtual reality exergameThe 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. |
| Conventional-based aerobic exercise | Active comparator | Behavioral: ConventionalThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality exergamevirtual reality exergame using Nintendo RingFit | Behavioural | virtual reality exergame |
| ConventionalConventional-based aerobic exercise using video aerobic exercise of the Ministry of Health (KEMENKES) protocol | Behavioural | Conventional-based aerobic exercise |
Primary outcome
physical activity
Time frame: 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.
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)
body composition (muscle mass)
Time frame: 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.
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%.
Hand muscle strength
Time frame: 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.
Hand muscle strength was measured using an electronic hand dynamometer, CAMRY ISO 9001 model EH101.
Muscle endurance
Time frame: 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.
Muscle endurance was measured using the 30-second sit-to-stand test with a stopwatch
Flexibility
Time frame: 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.
Flexibility was assessed using the Chair Sit-and-Reach Test.
body composition (fat mass)
Time frame: 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.
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 (Bone mass)
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- BackgroundRiebe, 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: PubMed 25030261Yeom 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.
- Results publicationMatos-Duarte M, Martínez-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
- Results publication: PubMed 36612530Mologne 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.
- Results publication: PubMed 34216098Alcazar 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.
- Results publication: PubMed 34207604Munoz-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.
- Results publication: PubMed 31464194Feodoroff 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.
- Results publicationJin, 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
- Results publication: PubMed 30018825Leiros-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.
- Results publicationNishi, 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.
- Results publication: PubMed 35058805Bai 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.
- Results publication: PubMed 38255047Rodriguez-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.
- 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 TrialLink provided by the sponsor.
- WHO - Multisectoral action for a life course approach to healthy ageing: draft global strategy and plan of action on ageing and healthLink provided by the sponsor.
- WHO guidelines on physical activity and sedentary behaviourLink provided by the sponsor.
- EFFECT OF AEROBIC EXERCISE ON PHYSICAL FUNCTION INDICES IN THE ELDERLYLink provided by the sponsor.
- The effect of low impact aerobic exercise on increasing physical fitness for the elderlyLink provided by the sponsor.
- EFFECT OF AEROBIC EXERCISE ON NEUROMUSCULAR QUALITY IN THE ELDERLYLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andi Amirah Shaleha Junaedi, MD, M.Sc principal investigator
Physical Medicine and Rehabilitation, Faculty of Medicine of Hasanuddin University, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality exergame and Conventional in people with Healthy Elderly, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089667, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.