Action Seniors! Exercise to Prevent Falls
This study is currently recruiting participants.
Verified February 2012 by University of British Columbia
Sponsor:
University of British Columbia
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01029171
First received: December 7, 2009
Last updated: February 28, 2012
Last verified: February 2012
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Purpose
This study will be a randomized controlled trial to determine the efficacy of the Otago Exercise Program (OEP) on falls among seniors with a history of falls.
| Condition | Intervention |
|---|---|
|
Falls |
Behavioral: Home-based balance and strength retraining exercise program. Behavioral: control; usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | "Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls. |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Falls over a 12 month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 344 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
OEP (Otago Exercise Program; home-based balance and strength retraining program)
|
Behavioral: Home-based balance and strength retraining exercise program.
A 12-month home-based balance and strength restraining program delivered by a physical therapist
|
|
Active Comparator: 2
CON (control; usual care)
|
Behavioral: control; usual care
Usual care as prescribed by geriatrician.
|
Detailed Description:
A total of 344 community-dwelling adults aged 70 years and older who are referred to a falls clinic secondary to seeking medical attention due to a fall will be randomized to either the 12-month OEP group or usual care. There will be three measurement sessions: baseline, 6 months, and 12 months.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adults older than or 70 years attending a Falls Prevention Clinic Service;
- Understands, speaks, and reads English proficiently;
- MMSE 8 score > 24/30;
- Had one documented non-syncopal fall in the last 12 months and one of the following: a) A Physiological Profile Assessment (PPA) score of at least 1 SD above normal; OR 2) Timed Up and Go Test (TUG) performance of greater than 15 seconds; OR 3) One additional documented non-syncopal fall in the previous 12 months;
- Expected to live greater than 12 months;
- Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
- Able to walk 3 meters with or without an assistive device; and
- Able to provide written informed consent.
Exclusion Criteria:
- Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
- Diagnosed with dementia (of any type);
- Had a stroke;
- Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
- Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029171
Contacts
| Contact: Jenna Homer | 604 875 4111 ext 66459 | jenna.homer@hiphealth.ca |
Locations
| Canada, British Columbia | |
| Centre for Hip Health and Mobility | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Jenna Homer 604 875 4111 ext 66459 jenna.homer@hiphealth.ca | |
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Teresa Liu-Ambrose | University of British Columbia |
| Study Director: | Karim Khan, Ph.D | University of British Columbia |
| Study Director: | Meghan Donaldson, Ph.D | University of British Columbia |
| Study Director: | Wendy Cook, Ph.D | University of British Columbia |
| Study Director: | Penny Brasher, Ph.D | University of British Columbia |
| Study Director: | Carlo Marra, Ph.D | University of British Columbia |
| Study Director: | Jennifer Davis, Ph.D | University of British Columbia |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01029171 History of Changes |
| Other Study ID Numbers: | H04-70171 |
| Study First Received: | December 7, 2009 |
| Last Updated: | February 28, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
falls balance training strength training |
ClinicalTrials.gov processed this record on June 18, 2013