- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05949359
The Feasibility of Nintendo RingFit to Improve Balance and Muscle Strength of Elders
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nintendo RingFit exercise group
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.
|
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. |
No Intervention: Control group
Usual care was received by the control group participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence
Time Frame: Throughout the 8-week exercise program
|
The attendance and retention of the participants in the trial
|
Throughout the 8-week exercise program
|
Adverse events
Time Frame: Throughout the 8-week exercise program
|
The number of adverse events as a result of the exercise program
|
Throughout the 8-week exercise program
|
Acceptability
Time Frame: At 8-week post-intervention
|
The acceptability of the participants toward the exercise program
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At 8-week post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Balance Evaluation Systems Test
Time Frame: Week 0 (baseline) and week 8 (post-assessment)
|
Balance, score range: 0 - 28, a higher score indicates better balance
|
Week 0 (baseline) and week 8 (post-assessment)
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Five-time-sit-to-stand test
Time Frame: Week 0 (baseline) and week 8 (post-assessment)
|
Lower limb muscle strength, sec
|
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)
|
General mobility and dual task ability, sec
|
Week 0 (baseline) and week 8 (post-assessment)
|
Iconographical Falls Efficacy Scale
Time Frame: Week 0 (baseline) and week 8 (post-assessment)
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Fear of falling, score range: 10 - 40, a higher score indicates greater fear of falling
|
Week 0 (baseline) and week 8 (post-assessment)
|
Color Trails Test
Time Frame: Week 0 (baseline) and week 8 (post-assessment)
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Attention and executive function, sec
|
Week 0 (baseline) and week 8 (post-assessment)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- URIS2021-111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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