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临床试验/NCT05949359
NCT05949359已完成不适用

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 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Acceptability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Nintendo RingFit-augmented exercise program (Other)

Control group

No Intervention

Usual care was received by the control group participants.

结局指标

主要结局

Acceptability

时间窗: At 8-week post-intervention

The acceptability of the participants toward the exercise program

Adherence

时间窗: Throughout the 8-week exercise program

The attendance and retention of the participants in the trial

Adverse events

时间窗: Throughout the 8-week exercise program

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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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