Steady Feet: Preventing Falls in the Community

Exercise Clinical Trial

Official title:

Steady Feet Falls Prevention Programme for Community-dwelling Older Adults at Risk for Falls in Singapore: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06371248
• Other study ID #: 2850
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: April 2024
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Exercise
• Fall
• Feasibility
• Older Adults

Intervention

Behavioral:
• Steady Feet
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.

Other:
• Usual care for fall prevention
CGH's usual care for fall prevention, which include fall prevention materials and advice.

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attendance and completion rates	Participants' attendance and completion records for the Steady Feet intervention.	an average of 12 weeks
Other	Safety of Steady Feet	Reports on adverse events (if any) during the study.	an average of 12 weeks
Primary	Short Physical Performance Battery (SPPB)	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	CONFbal	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
Secondary	Six-minute walk test (6MWT)	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
Secondary	Timed up and go (TUG)	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
Secondary	Four square step test (FSST)	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
Secondary	Feedback and satisfaction survey	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