Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 10:51 AM
Study NCT ID:
NCT07089667
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality Exergame on Physical Activity and Fitness in The Elderly
Sponsor:
Hasanuddin University
Organization:
Study Overview
Official Title:
The Effect of Virtual Reality Exergame on Physical Activity and Fitness in The Elderly
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 :
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: