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Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187317
First Posted: September 16, 2005
Last Update Posted: April 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Sunnybrook Health Sciences Centre
  Purpose
This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12.
Mansfield A, Peters AL, Liu BA, Maki BE. Effect of a perturbation-based balance training program on compensatory stepping and grasping reactions in older adults: a randomized controlled trial. Phys Ther. 2010 Apr;90(4):476-91. doi: 10.2522/ptj.20090070. Epub 2010 Feb 18.
Maki BE, McIlroy WE, Perry SD. Influence of lateral destabilization on compensatory stepping responses. J Biomech. 1996 Mar;29(3):343-53.
Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.
Rogers MW, Johnson ME, Martinez KM, Mille ML, Hedman LD. Step training improves the speed of voluntary step initiation in aging. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):46-51.
McIlroy WE, Maki BE. Age-related changes in compensatory stepping in response to unpredictable perturbations. J Gerontol A Biol Sci Med Sci. 1996 Nov;51(6):M289-96.
Maki BE, McIlroy WE. Change-in-support balance reactions in older persons: an emerging research area of clinical importance. Neurol Clin. 2005 Aug;23(3):751-83, vi-vii. Review.
Maki BE, Cheng KC, Mansfield A, Scovil CY, Perry SD, Peters AL, McKay S, Lee T, Marquis A, Corbeil P, Fernie GR, Liu B, McIlroy WE. Preventing falls in older adults: new interventions to promote more effective change-in-support balance reactions. J Electromyogr Kinesiol. 2008 Apr;18(2):243-54. Epub 2007 Sep 4.

Responsible Party: Brian Maki, Centre for Studies in Aging
ClinicalTrials.gov Identifier: NCT00187317     History of Changes
Other Study ID Numbers: NET-54025-01
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: April 2, 2010
Last Verified: April 2010

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


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