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Clinical Trials/NCT05949359
NCT05949359
Completed
N/A

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

The Hong Kong Polytechnic University1 site in 1 country43 target enrollmentAugust 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Accidental Falls
Sponsor
The Hong Kong Polytechnic University
Enrollment
43
Locations
1
Primary Endpoint
Adherence
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Five-time-sit-to-stand test(Week 0 (baseline) and week 8 (post-assessment))
  • Timed-Up and Go test - single and dual tasks(Week 0 (baseline) and week 8 (post-assessment))
  • Iconographical Falls Efficacy Scale(Week 0 (baseline) and week 8 (post-assessment))
  • Color Trails Test(Week 0 (baseline) and week 8 (post-assessment))
  • Mini-Balance Evaluation Systems Test(Week 0 (baseline) and week 8 (post-assessment))

Study Sites (1)

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