NCT05949359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

July 9, 2023

Last Update Submit

July 17, 2023

Conditions

Keywords

FallsExergamingFeasibility studiesAged

Outcome Measures

Primary Outcomes (3)

  • Adherence

    The attendance and retention of the participants in the trial

    Throughout the 8-week exercise program

  • Adverse events

    The number of adverse events as a result of the exercise program

    Throughout the 8-week exercise program

  • Acceptability

    The acceptability of the participants toward the exercise program

    At 8-week post-intervention

Secondary Outcomes (5)

  • Mini-Balance Evaluation Systems Test

    Week 0 (baseline) and week 8 (post-assessment)

  • 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)

Study Arms (2)

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.

Other: Nintendo RingFit-augmented exercise program

Control group

NO INTERVENTION

Usual care was received by the control group participants.

Interventions

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.

Nintendo RingFit exercise group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 18, 2023

Study Start

August 1, 2021

Primary Completion

April 30, 2023

Study Completion

June 30, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations