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

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

      • Singapore, Singapore, 529889
        • Changi General Hospital

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.
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.
Active Comparator: Control
Usual care for fall prevention.
CGH's usual care for fall prevention, which include fall prevention materials and advice.

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).
an average of 12 weeks

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.
an average of 12 weeks
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.
an average of 12 weeks
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.
an average of 12 weeks
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.
an average of 12 weeks
Feedback and satisfaction survey
Time Frame: an average of 12 weeks
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
an average of 12 weeks

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.
an average of 12 weeks
Safety of Steady Feet
Time Frame: an average of 12 weeks
Reports on adverse events (if any) during the study.
an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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