NCT01713543

Brief Summary

Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly is a critical health services delivery challenge. Hypothesis: An evidence-based program of screening, risk modification and physical therapy delivered in a community setting will reduce recurrent falls incidence among a high-risk group of elderly recently discharged to the community. Methodology: This randomized controlled trial targets patients seen at Emergency Department (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged to home. Upon signing the informed consent form, the participants will be followed up for nine months from the baseline assessment during which the participants are randomized into either a control or the intervention group. The participants in the intervention group will be provided with a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance, and gait training either as an individualized program or a group setting in the community for the first three months from the date of randomization. The number of recurrent falls will be monitored via a falls prevention diary maintained by (or for) each participant.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

October 22, 2012

Last Update Submit

September 4, 2015

Conditions

Accidental Falls

Keywords

falls

Outcome Measures

Primary Outcomes (1)

  • The number of fallers who have fallen at least once during the 9-month study period

    9 months

Secondary Outcomes (1)

  • The number of injurious falls and healthcare utilization

    9 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention consists of a tailored physical therapy focused on progressive strength, balance and gait training for a period of 3 months.

Other: physical therapy

Control Group

NO INTERVENTION

Usual care by physician.

Interventions

physical therapyOTHER

Tailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program.

Also known as: Falls Prevention
Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years
  • Seen in the Emergency Department for a fall or injury related to a fall
  • Able to follow 3 step commands
  • Singapore citizen or Permanent Resident
  • Living at home upon discharge
  • Provision of informed consent
  • If admitted to the hospital, the illness or disability is one from which they are expected to recover basic ADLs or weight bearing of the lower extremity within the next month

You may not qualify if:

  • Those patients with severe physical and/or mental impairments which preclude participation in a program of physical therapy (as determined by a primary physician) will NOT be eligible for participation.
  • Unable to participate in the exercise program due to conflicting schedules (e.g. full-time employment, on dialysis)
  • Serious life limiting illness
  • Patients seen at ED due to road traffic accidents
  • Unable to walk even with assistance
  • Not community dwelling prior to ED visit
  • Total blindness
  • Needs emergency inpatient surgery and, if admitted to the hospital, the illness or disability is one from which they are not expected to recover basic ADLs or weight bearing in the lower extremity within the next one month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (4)

  • Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.

    PMID: 17996052BACKGROUND

  • Matchar DB, Eom K, Duncan PW, Lee M, Sim R, Sivapragasam NR, Lien CT, Ong MEH. A Cost-Effectiveness Analysis of a Randomized Control Trial of a Tailored, Multifactorial Program to Prevent Falls Among the Community-Dwelling Elderly. Arch Phys Med Rehabil. 2019 Jan;100(1):1-8. doi: 10.1016/j.apmr.2018.07.434. Epub 2018 Aug 27.

    PMID: 30165053DERIVED

  • Pua YH, Ong PH, Clark RA, Matcher DB, Lim EC. Falls efficacy, postural balance, and risk for falls in older adults with falls-related emergency department visits: prospective cohort study. BMC Geriatr. 2017 Dec 21;17(1):291. doi: 10.1186/s12877-017-0682-2.

    PMID: 29268720DERIVED

  • Matchar DB, Duncan PW, Lien CT, Ong MEH, Lee M, Gao F, Sim R, Eom K. Randomized Controlled Trial of Screening, Risk Modification, and Physical Therapy to Prevent Falls Among the Elderly Recently Discharged From the Emergency Department to the Community: The Steps to Avoid Falls in the Elderly Study. Arch Phys Med Rehabil. 2017 Jun;98(6):1086-1096. doi: 10.1016/j.apmr.2017.01.014. Epub 2017 Feb 12.

    PMID: 28202383DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • David B Matchar, MD

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Program in Health Services & Systems Research, Duke-NUS

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 24, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

SG(2)