NCT04801316

Steady Feet: Proof of Value

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Community-dwelling Older Adults
• Fall Risk

Interventions

Type	Name	Description
BEHAVIORAL	Steady Feet exercise programme	Steady Feet (SF) is a 6-month community-based structured exercise programme aimed at improving physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls. This exercise programme was developed by Changi General Hospital's physiotherapists and exercise physiologist from evidence found in the literature.
BEHAVIORAL	Steady Feet Video	About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-03-17
• Last updated: 2023-08-31

Locations

1 site across 1 country: Singapore