Steady Feet: Preventing Falls in the Community

Not Applicable

Completed

• Conditions: Feasibility; Older Adults; Fall; Exercise
• Interventions: Behavioral: Steady Feet; Other: Usual care for fall prevention

• Registration Number: NCT06371248
• Lead Sponsor: Changi General Hospital

Brief Summary

The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program.

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 Timeline

• Study Start: 2018-11-19
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-17
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Usual care for fall prevention	Three-month, twice weekly, exercise intervention and usual care for fall prevention.
Intervention	Steady Feet	Three-month, twice weekly, exercise intervention and usual care for fall prevention.
Control	Usual care for fall prevention	Usual care for fall prevention.

Primary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	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).

Secondary Outcome Measures

Name	Time	Method
CONFbal	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.
Four square step test (FSST)	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.
Timed up and go (TUG)	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.
Six-minute walk test (6MWT)	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.
Feedback and satisfaction survey	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

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore