The Effect of Virtual Reality Exergame on Physical Activity and Fitness in The Elderly

NCT ID: NCT07089667

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2024-08-09

Brief Summary

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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

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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 :

1. 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).
2. 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

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Healthy Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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virtual reality exergame

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.

Group Type EXPERIMENTAL

virtual reality exergame

Intervention Type BEHAVIORAL

virtual reality exergame using Nintendo RingFit

Conventional-based aerobic exercise

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.

Group Type ACTIVE_COMPARATOR

Conventional

Intervention Type BEHAVIORAL

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

Interventions

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virtual reality exergame

virtual reality exergame using Nintendo RingFit

Intervention Type BEHAVIORAL

Conventional

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasanuddin University

OTHER

Sponsor Role lead

Responsible Party

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Andi Amirah Shaleha Junaedi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andi Amirah Shaleha Junaedi, MD, M.Sc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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GPIB Jemaat Bukit Zaitun

Makassar, South Sulawesi, Indonesia

Site Status

Countries

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Indonesia

References

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Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33375668/

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

https://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_17-en.pdf

WHO - Multisectoral action for a life course approach to healthy ageing: draft global strategy and plan of action on ageing and health

https://www.who.int/publications/i/item/9789240015128

WHO guidelines on physical activity and sedentary behaviour

https://www.scielo.br/j/rbme/a/sJJLhnrNn5G8FymrgdK46CC/#

EFFECT OF AEROBIC EXERCISE ON PHYSICAL FUNCTION INDICES IN THE ELDERLY

https://scholarhub.uny.ac.id/cgi/viewcontent.cgi?article=1034&context=jolahraga

The effect of low impact aerobic exercise on increasing physical fitness for the elderly

https://www.scielo.br/j/rbme/a/Gy99C9ycgYZkh8wLLyrFxFP/

EFFECT OF AEROBIC EXERCISE ON NEUROMUSCULAR QUALITY IN THE ELDERLY

https://eudl.eu/doi/10.4108/eai.28-4-2021.2312189

The Effect Of Aerobic Exercise On Body Weight and Body Fat Percentage

https://www.scielo.br/j/rbme/a/ypmRHWPjjT5f8dT77CwqKns/?format=pdf&lang=en

EFFECT OF AEROBIC EXERCISE ASSOCIATED WITH RESISTANCE TRAINING ON BODY COMPOSITION OF MIDDLE-AGED AND ELDERLY WOMEN

Other Identifiers

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UH24010039

Identifier Type: -

Identifier Source: org_study_id

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