Clinical trial NCT05949359: The Feasibility of Nintendo RingFit to Improve Balance and Muscle Strength of Elders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Falls
Exergaming
Feasibility studies
Aged
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: Throughout the 8-week exercise program
measure: Adverse events
timeFrame: Throughout the 8-week exercise program
measure: Acceptability
timeFrame: At 8-week post-intervention
Secondary outcomes:
measure: Mini-Balance Evaluation Systems Test
timeFrame: Week 0 (baseline) and week 8 (post-assessment)
measure: Five-time-sit-to-stand test
timeFrame: Week 0 (baseline) and week 8 (post-assessment)
measure: Timed-Up and Go test - single and dual tasks
timeFrame: Week 0 (baseline) and week 8 (post-assessment)
measure: Iconographical Falls Efficacy Scale
timeFrame: Week 0 (baseline) and week 8 (post-assessment)
measure: Color Trails Test
timeFrame: Week 0 (baseline) and week 8 (post-assessment)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: