ExergamingNCT05802537
Home-Based Exergame Program for Community-Dwelling Older Adults
A study testing Home-based exergame program and Online education on fall prevention and musculoskeletal health management in people with Exergaming and Frail Elderly, run by Kyungdong University at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the effect of a home-based exergame program on physical function, fall efficacy, depression, and quality of life in older adults. For the purpose of the study, the investigators established the following hypotheses. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exergaming, Frail Elderly
- What is being tested?
- Home-based exergame program and Online education on fall prevention and musculoskeletal health management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2022to 13 Jan 2023
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 75 years or older
- the ability to walk independently with or without a walking aid
- a mini-mental state examination score ≥ 24.
Who cannot join
- musculoskeletal disorders such as fractures or dislocations
- neurological impairment
- mental disorders
- uncontrolled endocrine, cardiovascular, or urinary system diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to investigate the effect of a home-based exergame program on physical function, fall efficacy, depression, and quality of life in older adults. For the purpose of the study, the investigators established the following hypotheses. Older adults who participate in a home-based exergame program will experience significant improvements in physical function, fall efficacy, depression, and quality of life compared to those who do not participate in the program.
- Conditions
- Exergaming, Frail Elderly
- Being tested
- Home-based exergame program, Online education on fall prevention and musculoskeletal health management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exergame programBehavioural
The home-based exergame program was conducted using the Nintendo Switch and Ring Fit Adventure program at participants' homes. The program included a 10-minute warm-up, 30 minutes of main exercise, and a 10-minute cool-down, lasting a total of 50 minutes per session. Sessions were held three times per week for eight weeks. The exercises targeted lower extremity strength, balance, and flexibility and included yoga, leg exercises (e.g., squats, knee lifts), and other activities performed in a gamified virtual environment. Participants received guidance on using the console, and family members were involved to support proper execution of the exercises.
Online education on fall prevention and musculoskeletal health managementBehavioural
The online education intervention consisted of weekly sessions conducted for 50 minutes over an eight-week period, focusing on fall prevention and musculoskeletal health management. Participants joined the sessions via a video-conference platform. The content covered education on aging, musculoskeletal disorders, fall prevention strategies, and understanding falls and fractures. These sessions aimed to enhance participants' awareness and knowledge, thereby helping them adopt preventive behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in the experimental group engaged in a home-based exergame program for 50 minutes per session, three times per week, for eight weeks. The program focused on enhancing lower extremity strength and balance. Receives: Behavioral: Home-based exergame program |
| Control group | Active comparator | The control group participated in weekly online education sessions for 50 minutes over an eight-week period. The topics covered included fall prevention, musculoskeletal health, aging, and fracture risks. No physical exercise intervention was given. Receives: Behavioral: Online education on fall prevention and musculoskeletal health management |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-leg standing test
The one-leg standing test was used to evaluate static postural balance. The one-leg standing test is a simple, reliable, and valid test for assessing balance and fall risk in older adults.
Measured: Change from baseline after intervention at 8 weeks
Berg balance scale
To evaluate dynamic postural balance, the Berg balance scale was used. It has a perfect score of 56 and consists of 14 items, with a perfect score of 4 for each item.
Measured: Change from baseline after intervention at 8 weeks
Functional reaching test
Functional reaching test was used to evaluate movement limits.
Measured: Change from baseline after intervention at 8 weeks
Timed up-and-go test
Timed up-and-go test was used to assess functional movement and mobility.
Measured: Change from baseline after intervention at 8 weeks
Five-times sit-to-stand test
Five-times sit-to-stand test was used to evaluate lower-extremity muscle strength.
Measured: Change from baseline after intervention at 8 weeks
Secondary outcomes (3)
Falls Efficacy
Falls efficacy was evaluated using the Modified Falls Efficacy Scale (MFES), which was specifically developed for older adults. The MFES consists of 14 questions, each scored from 0 (not confident) to 10 (very confident). The total score ranges from 0 to 140, with higher scores indicating greater confidence in performing activities without falling, which is considered a better outcome.
Measured: Change from baseline after intervention at 8 weeks
Depression
Depression was measured using the Geriatric Depression Scale-15 (GDS-15), a validated screening tool for older adults. The GDS-15 consists of 15 yes/no questions, with scores ranging from 0 to 15. Higher scores represent more severe depressive symptoms, which is considered a worse outcome.
Measured: Change from baseline after intervention at 8 weeks
Health-Related Quality of Life
Health-related quality of life was measured using the 36-Item Short Form Health Survey (SF-36), which assesses multiple domains of health status, including physical functioning, pain, role limitations, emotional problems, mental health, social functioning, vitality, and general health. The SF-36 contains 36 items, each rated on a scale from 1 to 5, with the total score converted to a range from 0 to 100. Higher scores indicate better health outcomes, reflecting a better quality of life.
Measured: Change from baseline after intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Nov 2022
- Primary completion7 Nov 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExergamingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungdong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyeongjin Lee, Kyungdong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802537
- Sponsor's protocol ID
- 1041455-202302-HR-003-01
- Status last verified
- Nov 2024
- First submitted
- 18 Mar 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee K. Home-Based Exergame Program to Improve Physical Function, Fall Efficacy, Depression and Quality of Life in Community-Dwelling Older Adults: A Randomized Controlled Trial. Healthcare (Basel). 2023 Apr 12;11(8):1109. doi: 10.3390/healthcare11081109.
PubMed 37107943
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Exergame Program for Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT05802537
- Acronym / sponsor ID
- 1041455-202302-HR-003-01
- Conditions
- Exergaming, Frail Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kyungdong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 6 Apr 2023 (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.
The purpose of this study was to investigate the effect of a home-based exergame program on physical function, fall efficacy, depression, and quality of life in older adults. For the purpose of the study, the investigators established the following hypotheses. Older adults who participate in a home-based exergame program will experience significant improvements in physical function, fall efficacy, depression, and quality of life compared to those who do not participate in the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Home-based exergame programParticipants in the experimental group engaged in a home-based exergame program for 50 minutes per session, three times per week, for eight weeks. The program focused on enhancing lower extremity strength and balance. |
| Control group | Active comparator | Behavioral: Online education on fall prevention and musculoskeletal health managementThe control group participated in weekly online education sessions for 50 minutes over an eight-week period. The topics covered included fall prevention, musculoskeletal health, aging, and fracture risks. No physical exercise intervention was given. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 75 years or older
- the ability to walk independently with or without a walking aid
- a mini-mental state examination score ≥ 24.
Key exclusion criteria (4 listed)
- musculoskeletal disorders such as fractures or dislocations
- neurological impairment
- mental disorders
- uncontrolled endocrine, cardiovascular, or urinary system diseases
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 |
|---|---|---|
| Home-based exergame programThe home-based exergame program was conducted using the Nintendo Switch and Ring Fit Adventure program at participants' homes. The program included a 10-minute warm-up, 30 minutes of main exercise, and a 10-minute cool-down, lasting a total of 50 minutes per session. Sessions were held three times per week for eight weeks. The exercises targeted lower extremity strength, balance, and flexibility and included yoga, leg exercises (e.g., squats, knee lifts), and other activities performed in a gamified virtual environment. Participants received guidance on using the console, and family members were involved to support proper execution of the exercises. | Behavioural | Experimental group |
| Online education on fall prevention and musculoskeletal health managementThe online education intervention consisted of weekly sessions conducted for 50 minutes over an eight-week period, focusing on fall prevention and musculoskeletal health management. Participants joined the sessions via a video-conference platform. The content covered education on aging, musculoskeletal disorders, fall prevention strategies, and understanding falls and fractures. These sessions aimed to enhance participants' awareness and knowledge, thereby helping them adopt preventive behaviors. | Behavioural | Control group |
Primary outcome
One-leg standing test
Time frame: Change from baseline after intervention at 8 weeks
The one-leg standing test was used to evaluate static postural balance. The one-leg standing test is a simple, reliable, and valid test for assessing balance and fall risk in older adults.
Berg balance scale
Time frame: Change from baseline after intervention at 8 weeks
To evaluate dynamic postural balance, the Berg balance scale was used. It has a perfect score of 56 and consists of 14 items, with a perfect score of 4 for each item.
Functional reaching test
Time frame: Change from baseline after intervention at 8 weeks
Functional reaching test was used to evaluate movement limits.
Timed up-and-go test
Time frame: Change from baseline after intervention at 8 weeks
Timed up-and-go test was used to assess functional movement and mobility.
Five-times sit-to-stand test
Time frame: Change from baseline after intervention at 8 weeks
Five-times sit-to-stand test was used to evaluate lower-extremity muscle strength.
3 secondary outcomes
Falls Efficacy
Time frame: Change from baseline after intervention at 8 weeks
Depression
Time frame: Change from baseline after intervention at 8 weeks
Health-Related Quality of Life
Time frame: Change from baseline after intervention at 8 weeks
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 5 Nov 2024.
- Derived from this study: PubMed 37107943Lee K. Home-Based Exergame Program to Improve Physical Function, Fall Efficacy, Depression and Quality of Life in Community-Dwelling Older Adults: A Randomized Controlled Trial. Healthcare (Basel). 2023 Apr 12;11(8):1109. doi: 10.3390/healthcare11081109.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exergame program and Online education on fall prevention and musculoskeletal health management in people with Exergaming and Frail Elderly, run by Kyungdong University at 1 site in South Korea.
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 3 inclusion and 4 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 5 Nov 2024. 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 South Korea. 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?
One-leg standing test (time frame: Change from baseline after intervention at 8 weeks). The study lists 5 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 NCT05802537, which also lists 1 linked publication.
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 5 Nov 2024.