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Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program

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ClinicalTrials.gov Identifier: NCT00187317
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 2, 2010
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Sunnybrook Health Sciences Centre

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

Condition or disease Intervention/treatment Phase
Accidental Falls Behavioral: Balance training (exercise) Other: Flexibility and relaxation exercise Phase 1

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  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development and Evaluation of a Perturbation-based Balance-training Program for Older Adults
Study Start Date : November 2005
Primary Completion Date : March 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Ability to recover balance by stepping and grasping [ Time Frame: Before and after 6-week intervention ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   64 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187317


Locations
Canada, Ontario
Centre for Studies in Aging, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Brian Maki, PhD, PEng Sunnybrook & Women's College Health Sciences Centre; University of Toronto

Publications:

Responsible Party: Brian Maki, Centre for Studies in Aging
ClinicalTrials.gov Identifier: NCT00187317     History of Changes
Other Study ID Numbers: NET-54025-01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: April 2010

Keywords provided by Sunnybrook Health Sciences Centre:
Exercise
Rehabilitation
Postural Balance
Accidental Falls
Geriatrics