A Multi-centre, Cluster Randomised Controlled Trial Comparing Falls Prevention Exergames With Remote Monitoring Against Standard Falls Prevention Programmes for Community Dwelling Older Adults at Risk of Falls.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Balance
研究概览
简要总结
This cluster RCT study will investigate the effectiveness of strength/balance Exergames (exercise and computer games that use body movements as controls) developed to improve balance, function, prevent falls and increase exercise adherence for older people in the home setting. The proposal incorporates postural stability Exergames that have been developed with users based on best evidence strength and balance exercise (OTAGO and Postural Stability) currently used by therapists, safe for older people and can be used in the home setting
详细描述
STUDY OBJECTIVES
Primary Question:
To determine the effect of using MIRA falls prevention Exergames to improve balance in older adults.
Secondary Question/Objectives:
- What features of usual falls prevention teams routines/activities need consideration for successful implementation of the strength and balance Exergame intervention?
- How can the Exergames be tailored for home use for older adults?
- What are the most effective outcome measurements to detect meaningful changes resulting from the MIRA Exergame programme?
- What are the current challenges and solutions to accessing robust data depicting costs of current therapy treatment compared to home-based MIRA Exergame treatment?
- Is it possible to retain participants in the intervention during the 12-week MIRA Exergame intervention with respect to outcomes including motivation, enjoyment and usability?
- What training and support needs are required to maximise the use of the MIRA Exergame technology?
- What are the costs of the MIRA Exergame intervention and how cost-effectiveness is the MIRA Exergame intervention compared with usual care.
- What are the effects on falls and fall-related use of health services during a 6-month follow up? STUDY DESIGN & PROTOCOL Participants This project is a cluster RCT study to test the effectiveness of undertaking MIRA Exergames in the sheltered home setting in addition to usual activities. A maximum of 12 sheltered housing units, with 108 participants will be recruited to participate in the study. These will be split into the experimental group (6 sheltered housing units with n=54) and the control group (6 sheltered housing units with n=54). These 2 groups will be based in 2 falls prevention teams in Manchester and a second site in Glasgow.
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
- 是
入选标准
- •Inclusion criteria for recruiting participants:
- •able to use gaming technology safely as assessed by the therapist, with access to television and a 2m space in the home to exercise safely (Note: Kinect-based Exergame system does not require the use of any hand-held consoles; and the exercises will be customised/tailored to each participant's needs, including those having difficulty standing a long time);
- •participants will be home-dwelling participants aged 60 years and above;
- •participants should be able to watch TV with or without glasses from a 2m distance;
- •participants should be English-speaking, and registered with primary care general practices; and
- •participants must have the mental capacity to give informed consent.
排除标准
- •currently using gaming technologies to exercise;
- •inability to comprehend the study procedures;
- •acute illness, severe congestive cardiac failure, uncontrolled hypertension, recent fracture or surgery;
- •Myocardial Infarction or Stroke in past 6 months;
- •severe cognitive impairment;
- •orthopaedic surgery in last 6 months, or on waiting list to have orthopaedic surgery;
- •wheelchair users;
- •severe auditory or visual impairment; and
- •peripheral neuropathy or other uncontrolled medical conditions likely to compromise the ability to exercise.
研究组 & 干预措施
Exergame plus usual treatment
Exergame programme plus usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists).
干预措施: Exergame plus usual treatment (Device)
Usual treatment
No exergame programme, just usual falls prevention treatment including assessment and exercises (prescribed by the physiotherapists).
结局指标
主要结局
Balance
时间窗: 12 weeks
The Berg Balance Scale (BBS)
次要结局
- Lower limb strength(12 weeks)
- Mood(12 weeks)
- Fear of falling(12 weeks)
- Cognition(12 weeks)
- Adherence(12 weeks)
- Physical activity levels(12 weeks)
研究者
Dr Emma Stanmore
Dr
University of Manchester