Fall Prevention Program for Older Adults

NCT00714051 | Completed Phase 1 Results

• 1 other identifier: E4955-R
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Fell on a Tripping Test

  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

Study Arms (2)

Fall Prevention Training

EXPERIMENTAL

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

Attention Control

ACTIVE COMPARATOR

The attention control group participated in four weekly treadmill walking sessions at a self-selected speed.

Behavioral: Attention Control

Interventions

fall prevention training BEHAVIORAL

Training on a specialized treadmill that produced trip-simulating perturbations (movements.

Fall Prevention Training

Attention Control BEHAVIORAL

Participants walked on a treadmill at a self-selected speed once per week for four weeks.

Attention Control

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• yr old,
• normal reflexes and muscle tone

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Results Point of Contact

• Title: Eileen Collins PhD, RN
• Organization: Edward Hines Jr., VA Hospital

eileen.collins@va.gov

708-202-3525

Study Officials

• Eileen G. Collins, PhD RN

  Edward Hines Jr. VA Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: October 1, 2014
• Last Updated: October 8, 2014
• Results First Posted: October 8, 2014

Record last verified: 2014-10

Locations

US (1)