NCT06371248

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 8, 2024

Last Update Submit

April 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • CONFbal

    an average of 12 weeks

  • Six-minute walk test (6MWT)

    an average of 12 weeks

  • Timed up and go (TUG)

    an average of 12 weeks

  • Four square step test (FSST)

    an average of 12 weeks

  • Feedback and satisfaction survey

    an average of 12 weeks

Other Outcomes (2)

  • Attendance and completion rates

    an average of 12 weeks

  • Safety of Steady Feet

    an average of 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Three-month, twice weekly, exercise intervention and usual care for fall prevention.

Behavioral: Steady FeetOther: Usual care for fall prevention

Control

ACTIVE COMPARATOR

Usual care for fall prevention.

Other: Usual care for fall prevention

Interventions

Steady FeetBEHAVIORAL

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.

Intervention

CGH's usual care for fall prevention, which include fall prevention materials and advice.

ControlIntervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shou Lin Low, MRCP (UK)

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 17, 2024

Study Start

November 19, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

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.

Locations