Steady Feet: Proof of Value

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Modified Stepping Trainings in Frailty Elderly With Physical Performance- a Prospective Randomized Controlled Trial

NCT06505083

Rehabilitation Training Respiratory Muscle Strength

COMPLETED NA

Effect of Singapore-contextualized Dance-based Exergame Among Community-dwelling Older Adults

NCT05887648

Community-dwelling Older Adults

COMPLETED NA

STAND UP - Sedentary Behaviour in Older Adults: Investigating a New Therapeutic Paradigm

NCT02453204

Older Adults

COMPLETED NA

Combating Hospital-related Function Decline Among Prefrail Older Adults: A Pilot Study

NCT06191276

Frailty Geriatrics

COMPLETED NA

Yoga for Seniors

NCT04889131

Aging Well

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Community-dwelling Older Adults Fall Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part 1 of the study is a pre-post non-randomised study with qualitative methods. Part 2 is an open-label, parallel randomized controlled trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Steady Feet Video

Intervention Type BEHAVIORAL

About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme

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:

1. 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.
2. A 3 months maintenance exercise phase. A once-weekly structured community group exercise class.

Group Type EXPERIMENTAL

Steady Feet exercise programme

Intervention Type BEHAVIORAL

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.

Part 2: Control

Participants will be provided with the usual education and advice on how to reduce their risk of falls.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Steady Feet Video

About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female aged 21 years and older
* Are involved in the planning or implementation of the exercise programme

* 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)

Part 2:

* 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)

Exclusion Criteria

* 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)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes