Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program

April 1, 2010 updated by: Sunnybrook Health Sciences Centre

Development and Evaluation of a Perturbation-based Balance-training Program for Older Adults

This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physical activity and exercise have been shown to prevent falling in older adults, although the exact mechanisms by which exercise prevents falls is unclear. Compensatory stepping and grasping reactions are frequently used to prevent a fall to the ground following a loss of balance. Age-related impairment in these reactions may be related to an increased risk of falling. Therefore, the purpose of this study is to investigate means for reversing age-related impairment in compensatory stepping and grasping reactions. A training program involving perturbation-evoked reactions will be evaluated.

Comparison(s): Balance recovery ability before and after a 6-week training program will be assessed. Performance of the training group will be compared to a control group not receiving stepping and grasping training.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • 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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Centre for Studies in Aging, Sunnybrook Health Sciences Centre

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

64 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community dwelling
  • History of falls (at least 1 fall in the past 12 months) or poor balance
  • Functional mobility (no dependence on mobility aids)

Exclusion Criteria:

  • Neurological or musculoskeletal disorder
  • Cognitive disorder (e.g. dementia)
  • Osteoporosis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PERT
Perturbation-based balance training.
Behavioral: Balance training (exercise)
Perturbation-based balance training. 30-minute sessions three times per week for six weeks.
Placebo Comparator: CON
Flexibility and relaxation training.
Other: Flexibility and relaxation exercise
30-minute sessions, three times per week for six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ability to recover balance by stepping and grasping
Time Frame: Before and after 6-week intervention
Before and after 6-week intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Fall frequency; clinical measures related to balance and fall risk (e.g. FallScreen, Community Balance and Mobility Scale, balance confidence)
Time Frame: One year post-intervention
One year post-intervention

Collaborators and Investigators

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

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Brian Maki, PhD, PEng, Sunnybrook & Women's College Health Sciences Centre; University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 2, 2010

Last Update Submitted That Met QC Criteria

April 1, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NET-54025-01

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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