Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program

Accidental Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187317
• Other study ID #: NET-54025-01
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: April 1, 2010
• Start date: November 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2010
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 64 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Behavioral:
• Balance training (exercise)
Perturbation-based balance training. 30-minute sessions three times per week for six weeks.

Other:
• Flexibility and relaxation exercise
30-minute sessions, three times per week for six weeks.

Locations

Country	Name	City	State
Canada	Centre for Studies in Aging, Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

Maki BE, McIlroy WE, Perry SD. Influence of lateral destabilization on compensatory stepping responses. J Biomech. 1996 Mar;29(3):343-53. — View Citation

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. — View Citation

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. — View Citation

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. E — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to recover balance by stepping and grasping		Before and after 6-week intervention	No
Secondary	Fall frequency; clinical measures related to balance and fall risk (e.g. FallScreen, Community Balance and Mobility Scale, balance confidence)		One year post-intervention	No