Fall Prevention Program for Older Adults

October 2, 2014 updated by: US Department of Veterans Affairs
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

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

  • United States
    • Illinois
      • Hines, Illinois, United States, 60141-5000
        • Edward Hines, Jr. VA 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

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65-80 yr old,
  • normal reflexes and muscle tone

Exclusion Criteria:

  • lower extremity fracture or surgery last 5 yrs
  • back surgery or disc herniation last 5 yrs
  • noticeable gait impairment,
  • low back pain,
  • decreased disease-related vision,
  • dizziness,
  • history of heart problems,
  • bone mineral density <.65,
  • mini-mental score <24

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fall Prevention Training
The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
Behavioral: fall prevention training
Training on a specialized treadmill that produced trip-simulating perturbations (movements.
ACTIVE_COMPARATOR: Attention Control
The attention control group participated in four weekly treadmill walking sessions at a self-selected speed.
Behavioral: Attention Control
Participants walked on a treadmill at a self-selected speed once per week for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Fell on a Tripping Test
Time Frame: 4 weeks
Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

University of Illinois at Chicago

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

October 1, 2008

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 8, 2008

First Posted (ESTIMATE)

July 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • E4955-R

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.

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