Steady Feet: Proof of Value
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Part 1: Changes from pre-competency checklist scores
研究概览
简要总结
It is well established that poorer functional performance is associated with falls in older adults. Exercise is shown to be an effective evidence-based intervention in improving functional performance. However, there is a lack of a specially tailored structured exercise intervention in Singapore to address this. In response, a 6-months community-based structured exercise programme, called "Steady Feet" (SF) was developed. It aimed to improve physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls.
Concurrently, COVID-19 led to reduced training and exercise opportunities. There is now a need for alternatives to aid in the training of community instructors, and to carry out exercise programmes for community-dwelling older adults.
Thus, the objectives of this study are to examine (1) evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the SF classes. (2) Evaluate the effects of the SF programme (intervention group) on functional status among older adults (aged 60 years and above), compared with a group of older adults that did not participate in the SF programme (control group).
详细描述
There will be two parts to this study, part 1: a feasibility study, and part 2: a randomised controlled trial (RCT).
The aim of part 1 is to evaluate the feasibility of using videos as a facilitation tool for training community instructors and the implementation of the Steady Feet (SF) classes.
Part 1 comprises a pre-post design and qualitative methods. Community instructors' competency levels of class execution will be compared before and after the video-facilitated training. Interviews or focus group discussions will be conducted for community providers, instructors, and community-dwelling older adults to explore the acceptability, appropriateness, feasibility of the exercise video, and to obtain feedback and any recommendations for improvements. This part of the study aims to recruit 30 participants.
The aim of part 2 is to examine the effectiveness of the SF Programme on improving functional outcomes in older adults (aged 60 years and above) with a high risk of falls.
Part 2 comprises an open-label, parallel randomized controlled trial. At least 260 participants (130 intervention and 130 control) with a Short Physical Performance Battery (SPPB) score of 7 to 10, no significant cognitive impairment and vision issues will be recruited to be part of the study. Participants will be randomized to the intervention or control group before the baseline visit and will be followed-up prospectively at the 3rd month, and 6th month. Repeated measures will be performed at the pre-defined time points. The primary outcome of interest is the difference in Short Performance Physical Battery (SPPB) scores between the intervention and control groups at 6 months. Intention to treat analysis will be used. Other outcomes, such as functional assessments, balance confidence, fear of falling, quality of life, healthcare utilisation, and cost, and fall history will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community providers or instructors will be eligible if they meet all the following inclusion criteria:
- •Male or female aged 21 years and older
- •Are involved in the planning or implementation of the exercise programme
- •Community-dwelling participants will be eligible if they meet all the following inclusion criteria during screening:
- •Aged 60 years and older
- •SPPB score: 7 to 10
- •Passes at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- •Does not possess significant cognitive impairment (AMT ≥ 5)
- •Inclusion Criteria:
- •Aged 60 years and older
- •SPPB score: 7 to 10
- •Passes at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- •Does not possess significant cognitive impairment (AMT ≥ 5)
排除标准
- •Male or female aged < 60 years old
- •SPPB score of ≥ 11 or ≤ 6
- •Did not pass at least 2 out of 3 Vision Function Test(s) (LogMar vision, Stereoscopic vision, MET)
- •Possess significant cognitive impairment (AMT < 5)
研究组 & 干预措施
Part 1: Video training
Participants will undergo the following procedures:
Community instructors (involved in the training itself):
- Attend a video-facilitated training
- Be assessed for competency level of class execution before and after the video-facilitated training
- Might need to conduct or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week)
- Might need to participate in one interview/discussion which will last up to 2 hours
Community-dwelling older adult or community providers (individuals involved in the programme implementation but not the training itself):
- Attend or observe 2 video-facilitated SF exercise classes (about 1 hour each time) over the course of 2 weeks (1 class per week)
- Participate in one interview/discussion which will last up to 2 hours
干预措施: Steady Feet Video (Behavioral)
Part 2: Exercise Intervention
Participants will participate in 6 months of exercises, and be provided with education and advice on how to reduce their risk of falls.
The exercises are divided into 2 phases:
- The Steady Feet (SF) exercise programme phase. A twice-weekly tailored structured group exercise class will be conducted for 3 months with community instructors and exercise video.
- A 3 months maintenance exercise phase. A once-weekly structured community group exercise class.
干预措施: Steady Feet exercise programme (Behavioral)
Part 2: Control
Participants will be provided with the usual education and advice on how to reduce their risk of falls.
结局指标
主要结局
Part 1: Changes from pre-competency checklist scores
时间窗: Pre (prior to the video training), post (immediately after the video training)
The competency checklist covers 25 different exercise steps during class execution. Trainers (physiotherapists and exercise physiologists) will indicate a "tick" if the trainee has accurately demonstrated the steps as taught during the video-facilitated training.
Part 2: Changes from baseline Short Performance Physical Battery (SPPB) scores
时间窗: Baseline, 3rd month, and 6th month
The SPPB is a series of assessments used to evaluate lower extremity function. It consists of 3 types of balance tests (side-by-side stand, semi-tandem stand, tandem stand), a 4 metres gait speed test, and a chair stand test. Scores of each component are summed to form a total SPPB score.
次要结局
- Part 2: Changes from baseline ConfBAL scale scores(Baseline, 3rd month, and 6th month)
- Part 2: Changes from baseline Fear of Falling scores(Baseline, 3rd month, and 6th month)
- Part 2: Changes from baseline EQ-5D-5L scores(Baseline, 3rd month, and 6th month)
- Part 2: Changes from baseline injurious falls(Baseline, and 6th month)
- Part 2: Incremental healthcare utilisation and costs over the study period(3rd month, and 6th month)
研究者
Low Shou Lin
Senior Consultant
Changi General Hospital