- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06371248
Steady Feet: Preventing Falls in the Community
April 12, 2024 updated by: Low Shou Lin, Changi General Hospital
Steady Feet Falls Prevention Programme for Community-dwelling Older Adults at Risk for Falls in Singapore: A Feasibility Study
The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants aged 60 or older, at high risk of falls, with Short Physical Performance Battery (SPPB) scores between 7 and 11, and without significant cognitive or vision impairment, were recruited for a non-randomized, two-arm study.
They were evaluated at baseline and the third month.
The intervention group (IG) underwent Steady Feet and CGH's standard care for fall prevention, while the control group (CG) received CGH's standard care for fall prevention.
Feasibility was assessed across Bowen's domains, including acceptability, demand, implementation, practicality, adaptation, and limited efficacy.
Measurements included SPPB, Timed Up and Go, the 6-minute walk test, the Four-Square Step Test, the CONFbal scale, and a satisfaction survey administered to IG participants.
Between-groups statistical analyses will be performed.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 529889
- Changi General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 60 years and above
- At high risk of falls according to the FROP-COM
- Short Physical Performance Battery (SPPB) score of 7 to 11
- Able to ambulate without wheelchairs or walkers
- Able to understand basic instructions.
Exclusion Criteria:
- Possess significant cognitive impairment (Abbreviated Mental Test < 5)
- Had visual impairment, as determined by not passing at least 2 out of 3 Vision Function Test(s) (Logarithm of the Minimum Angle of Resolution (LogMar) vision, Stereoscopic vision, and Melbourne Edge Test (MET)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Three-month, twice weekly, exercise intervention and usual care for fall prevention.
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Steady Feet is a three-month progressive exercise-based single-component intervention spanning twenty-four sessions, with a focus on enhancing balance, mobility, and strength among community-dwelling older adults at risk of falls.
CGH's usual care for fall prevention, which include fall prevention materials and advice.
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Active Comparator: Control
Usual care for fall prevention.
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CGH's usual care for fall prevention, which include fall prevention materials and advice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: an average of 12 weeks
|
SPPB comprises three components, (i) static balance, (ii) gait speed, and (iii) chair stands.
A higher score on the SPPB is indicative of better physical functional status (maximum score of 12 points).
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an average of 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CONFbal
Time Frame: an average of 12 weeks
|
The CONFbal scale is a ten-item measure used to assess self-reported confidence in maintaining balance under different conditions.
The overall CONFbal score ranges from 10 to 30.
Lower scores reflect higher levels of subjective balance confidence.
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an average of 12 weeks
|
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Six-minute walk test (6MWT)
Time Frame: an average of 12 weeks
|
The 6MWT is a validated tool for assessing functional status and endurance in older adults.
Participants are instructed to walk continuously for six minutes along a ten-meter course, which is marked with a turnaround point to enable participants to walk to-and-fro.
The total distance walked during the test is recorded.
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an average of 12 weeks
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Timed up and go (TUG)
Time Frame: an average of 12 weeks
|
The TUG is used to evaluate gait, balance, and dynamic mobility in individuals.
Participants are instructed to rise from a seated position, walk three meters to the endpoint marked with an object, and return to the seat.
The time taken to complete the assessment is recorded.
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an average of 12 weeks
|
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Four square step test (FSST)
Time Frame: an average of 12 weeks
|
The FSST is a validated measure of coordination and dynamic stability in older adults.
Participants are asked to quickly step forward, backward, and sideways over a low obstacle, following a predetermined sequence delineated by four squares marked on the ground.
The time taken to complete the task was recorded.
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an average of 12 weeks
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Feedback and satisfaction survey
Time Frame: an average of 12 weeks
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The self-developed feedback and satisfaction survey assessed participant satisfaction with the SF sessions, the instructors, the venue, the pace, the exercises, and the perceived effects of SF on their health
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an average of 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance and completion rates
Time Frame: an average of 12 weeks
|
Participants' attendance and completion records for the Steady Feet intervention.
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an average of 12 weeks
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Safety of Steady Feet
Time Frame: an average of 12 weeks
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Reports on adverse events (if any) during the study.
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an average of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shou Lin Low, MRCP (UK), Changi General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2018
Primary Completion (Actual)
December 20, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
April 8, 2024
First Submitted That Met QC Criteria
April 12, 2024
First Posted (Actual)
April 17, 2024
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2850
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data that support the findings of this study are available on request from the corresponding author.
The data are not publicly available due to ethical restrictions.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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