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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Three-month, twice weekly, exercise intervention and usual care for fall prevention.
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.
Active Comparator: Control
Usual care for fall prevention.
Other: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changi General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings