Accidental FallsNCT05949359
The Feasibility of Nintendo RingFit to Improve Balance and Muscle Strength of Elders
A study testing Nintendo RingFit-augmented exercise program in people with Accidental Falls, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Background Existing findings have suggested that exergaming (i.e., exercise that requires people to move their body to play, providing an active gaming experience while serving as a form of physical activity), may have a potential to improve muscle strength and balance in older adults. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Nintendo RingFit-augmented exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2021to 30 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- were 60 years old or above;
- had at least one fall in the past year;
- were able to walk independently without a walking aid for at least 10 meters;
- had no previous experience of using the Nintendo RingFit.
Who cannot join
- had a severe musculoskeletal, cardiopulmonary or neurological condition that limited their participation in the exercise program or assessment;
- had a significant visual or hearing impairment that limited their ability to follow exercise instructions;
- scored 18 or below in the Montreal Cognitive Assessment Hong Kong version (HK-MoCA) 4; or
- participated in any structured exercise program in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Balance and Muscle Strengthening Exercise Program Using the Nintendo RingFit in Community-dwelling Older Adults With a History of Falls - a Feasibility Randomized Controlled Trial
Background Existing findings have suggested that exergaming (i.e., exercise that requires people to move their body to play, providing an active gaming experience while serving as a form of physical activity), may have a potential to improve muscle strength and balance in older adults. However, no study has been conducted to investigate the effects of the Nintendo RingFit - an action role-playing game that aims to provide exercise training using a ring-shaped force sensor - in improving muscle strength and balance and possibly reducing falls in older adults living in the community.
Objective This study aims to investigate the feasibility of an exercise training program using Nintendo RingFit to improve balance and muscle strength among community-dwelling older adults.
Read more
Design A single-blind, randomized controlled feasibility trial.
Methods 30 participants will be recruited at local community-based elderly centers. Participants will be randomized to either the Nintendo RingFit-based exercise training group (NRE) or control group (CON) group with an allocation ratio of 1:1 by a researcher who will not participate in the recruitment and outcome evaluation. The NRE group will received an 8-week exercise training focusing on balance and lower limb muscle strength using the Nintendo RingFit. The CON group will receive a booklet and verbal instructions on the exercise for falls prevention, will be invited to join a leisure activity program (e.g., singing group) without any active exercise component for 8 weeks.
Outcomes The feasibility, acceptability and safety of the program will be examined at the end of the intervention. Postural balance, lower extremity strength, mobility, attention and executive function, fear of falling, and falls incidence of the participants will be assessed at 8 weeks.
Statistical analyses Descriptive statistics were presented for all variables. Chi-Square Test will be used to compare the difference in the proportion of fallers between the NRE and CON groups. Mann-Whitney U Test will be used to compare the functional outcomes between the 2 groups.
- Conditions
- Accidental Falls
- Being tested
- Nintendo RingFit-augmented exercise program
- Keywords
- Falls, Exergaming, Feasibility studies, Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo RingFit-augmented exercise programOther
Participants in the NRE group received an 8-week exercise training program using the Nintendo RingFit (60 minutes for each session, two sessions a week). In each session, the participants first performed 5 minutes of walk-up exercises (i.e., simple jogging), followed by 50 minutes of Nintendo RingFit exercises and 5 minutes of cool down exercises.
The exercise intensity, in terms of repetitions, holding time of the exercise and advancement to difficult tasks, progressed gradually in 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nintendo RingFit exercise group | Experimental | Participants in the Nintendo RingFit exercise group received an 8-week, twice-weekly exercise program focusing on improving balance and lower limb muscle strength using Nintendo RingFit device. Receives: Other: Nintendo RingFit-augmented exercise program |
| Control group | No intervention | Usual care was received by the control group participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
The attendance and retention of the participants in the trial
Measured: Throughout the 8-week exercise program
Adverse events
The number of adverse events as a result of the exercise program
Measured: Throughout the 8-week exercise program
Acceptability
The acceptability of the participants toward the exercise program
Measured: At 8-week post-intervention
Secondary outcomes (5)
Mini-Balance Evaluation Systems Test
Balance, score range: 0 - 28, a higher score indicates better balance
Measured: Week 0 (baseline) and week 8 (post-assessment)
Five-time-sit-to-stand test
Lower limb muscle strength, sec
Measured: Week 0 (baseline) and week 8 (post-assessment)
Timed-Up and Go test - single and dual tasks
General mobility and dual task ability, sec
Measured: Week 0 (baseline) and week 8 (post-assessment)
Iconographical Falls Efficacy Scale
Fear of falling, score range: 10 - 40, a higher score indicates greater fear of falling
Measured: Week 0 (baseline) and week 8 (post-assessment)
Color Trails Test
Attention and executive function, sec
Measured: Week 0 (baseline) and week 8 (post-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Aug 2021
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949359
- Sponsor's protocol ID
- URIS2021-111
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Balance and Muscle Strengthening Exercise Program Using the Nintendo RingFit in Community-dwelling Older Adults With a History of Falls - a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05949359
- Acronym / sponsor ID
- URIS2021-111
- Conditions
- Accidental Falls
- Keywords
- Falls, Exergaming, Feasibility studies, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Jul 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.
Background Existing findings have suggested that exergaming (i.e., exercise that requires people to move their body to play, providing an active gaming experience while serving as a form of physical activity), may have a potential to improve muscle strength and balance in older adults. However, no study has been conducted to investigate the effects of the Nintendo RingFit - an action role-playing game that aims to provide exercise training using a ring-shaped force sensor - in improving muscle strength and balance and possibly reducing falls in older adults living in the community.
Objective This study aims to investigate the feasibility of an exercise training program using Nintendo RingFit to improve balance and muscle strength among community-dwelling older adults.
Design A single-blind, randomized controlled feasibility trial.
Methods 30 participants will be recruited at local community-based elderly centers. Participants will be randomized to either the Nintendo RingFit-based exercise training group (NRE) or control group (CON) group with an allocation ratio of 1:1 by a researcher who will not participate in the recruitment and outcome evaluation. The NRE group will received an 8-week exercise training focusing on balance and lower limb muscle strength using the Nintendo RingFit. The CON group will receive a booklet and verbal instructions on the exercise for falls prevention, will be invited to join a leisure activity program (e.g., singing group) without any active exercise component for 8 weeks.
Outcomes The feasibility, acceptability and safety of the program will be examined at the end of the intervention. Postural balance, lower extremity strength, mobility, attention and executive function, fear of falling, and falls incidence of the participants will be assessed at 8 weeks.
Statistical analyses Descriptive statistics were presented for all variables. Chi-Square Test will be used to compare the difference in the proportion of fallers between the NRE and CON groups. Mann-Whitney U Test will be used to compare the functional outcomes between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintendo RingFit exercise group | Experimental | Other: Nintendo RingFit-augmented exercise programParticipants in the Nintendo RingFit exercise group received an 8-week, twice-weekly exercise program focusing on improving balance and lower limb muscle strength using Nintendo RingFit device. |
| Control group | No intervention | –Usual care was received by the control group participants. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- were 60 years old or above;
- had at least one fall in the past year;
- were able to walk independently without a walking aid for at least 10 meters;
- had no previous experience of using the Nintendo RingFit.
Key exclusion criteria (4 listed)
- had a severe musculoskeletal, cardiopulmonary or neurological condition that limited their participation in the exercise program or assessment;
- had a significant visual or hearing impairment that limited their ability to follow exercise instructions;
- scored 18 or below in the Montreal Cognitive Assessment Hong Kong version (HK-MoCA) 4; or
- participated in any structured exercise program in the past 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 |
|---|---|---|
| Nintendo RingFit-augmented exercise programParticipants in the NRE group received an 8-week exercise training program using the Nintendo RingFit (60 minutes for each session, two sessions a week). In each session, the participants first performed 5 minutes of walk-up exercises (i.e., simple jogging), followed by 50 minutes of Nintendo RingFit exercises and 5 minutes of cool down exercises. The exercise intensity, in terms of repetitions, holding time of the exercise and advancement to difficult tasks, progressed gradually in 8 weeks. | Other | Nintendo RingFit exercise group |
Primary outcome
Adherence
Time frame: Throughout the 8-week exercise program
The attendance and retention of the participants in the trial
Adverse events
Time frame: Throughout the 8-week exercise program
The number of adverse events as a result of the exercise program
Acceptability
Time frame: At 8-week post-intervention
The acceptability of the participants toward the exercise program
5 secondary outcomes
Mini-Balance Evaluation Systems Test
Time frame: Week 0 (baseline) and week 8 (post-assessment)
Five-time-sit-to-stand test
Time frame: Week 0 (baseline) and week 8 (post-assessment)
Timed-Up and Go test - single and dual tasks
Time frame: Week 0 (baseline) and week 8 (post-assessment)
Iconographical Falls Efficacy Scale
Time frame: Week 0 (baseline) and week 8 (post-assessment)
Color Trails Test
Time frame: Week 0 (baseline) and week 8 (post-assessment)
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 19 Jul 2023.
- 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 Nintendo RingFit-augmented exercise program in people with Accidental Falls, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 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 19 Jul 2023. 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 Hong Kong. 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?
Adherence (time frame: Throughout the 8-week exercise program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2023.