Evaluation of a Balance-Recovery Specific Falls Prevention Exercise Program - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

August 4, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ability to recover balance by stepping and grasping [ Time Frame: Before and after 6-week intervention ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Ability to recover balance by stepping and grasping

Change History

Complete list of historical versions of study NCT00187317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Fall frequency; volitional stepping and grasping reaction time; clinical measures related to balance and fall risk (e.g. FallScreen, Community Balance and Mobility Scale, balance confidence)

Descriptive Information

Brief Title ^ICMJE

Evaluation of a Balance-Recovery Specific Falls Prevention Exercise Program

Official Title ^ICMJE

Development and Evaluation of a Perturbation-Based Balance-Training Program for Older Adults

Brief Summary

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

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Accidental Falls

Intervention ^ICMJE

Behavioral: Balance training (exercise)
Other: Flexibility and relaxation exercise

Study Arms / Comparison Groups

Experimental: Perturbation-based balance training.
Placebo Comparator: Flexibility and relaxation training.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2008

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

64 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00187317

Responsible Party

Brian Maki, Centre for Studies in Aging

Study ID Numbers ^ICMJE

NET-54025-01

Study Sponsor ^ICMJE

Sunnybrook Health Sciences Centre

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)

Investigators ^ICMJE

Principal Investigator:

Brian Maki, PhD, PEng

Sunnybrook & Women's College Health Sciences Centre; University of Toronto

Information Provided By

Sunnybrook Health Sciences Centre

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP