The Feasibility of Nintendo RingFit to Improve Balance and Muscle Strength of Elders

Accidental Falls Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05949359
• Other study ID #: URIS2021-111
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• Nintendo RingFit-augmented exercise program
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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	The attendance and retention of the participants in the trial	Throughout the 8-week exercise program
Primary	Adverse events	The number of adverse events as a result of the exercise program	Throughout the 8-week exercise program
Primary	Acceptability	The acceptability of the participants toward the exercise program	At 8-week post-intervention
Secondary	Mini-Balance Evaluation Systems Test	Balance, score range: 0 - 28, a higher score indicates better balance	Week 0 (baseline) and week 8 (post-assessment)
Secondary	Five-time-sit-to-stand test	Lower limb muscle strength, sec	Week 0 (baseline) and week 8 (post-assessment)
Secondary	Timed-Up and Go test - single and dual tasks	General mobility and dual task ability, sec	Week 0 (baseline) and week 8 (post-assessment)
Secondary	Iconographical Falls Efficacy Scale	Fear of falling, score range: 10 - 40, a higher score indicates greater fear of falling	Week 0 (baseline) and week 8 (post-assessment)
Secondary	Color Trails Test	Attention and executive function, sec	Week 0 (baseline) and week 8 (post-assessment)