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Completed

NCT Number: NCT06371248

Steady Feet: Preventing Falls in the Community

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

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Key information

Conditions

Fall Behavior Exercise Feasibility Motor Activity Older Adults

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Steady Feet

Behavioral

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.

Usual care for fall prevention

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Other outcomes

  1. Attendance and completion rates

    Time frame: an average of 12 weeks

    Participants' attendance and completion records for the Steady Feet intervention.

  2. Safety of Steady Feet

    Time frame: an average of 12 weeks

    Reports on adverse events (if any) during the study.

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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