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Action Seniors! Exercise to Prevent Falls

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029171
First Posted: December 9, 2009
Last Update Posted: October 4, 2017
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 (Responsible Party):
Teresa Liu-Ambrose, University of British Columbia
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 Teresa Liu-Ambrose, University of British Columbia:

Primary Outcome Measures:
  • Falls over a 12 month period. [ Time Frame: 12 months ]

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 ]

Estimated Enrollment: 344
Study Start Date: November 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults older than or 70 years attending a Falls Prevention Clinic Service;
  2. Understands, speaks, and reads English proficiently;
  3. MMSE 8 score > 24/30;
  4. 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;
  5. Expected to live greater than 12 months;
  6. Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
  7. Able to walk 3 meters with or without an assistive device; and
  8. Able to provide written informed consent.

Exclusion Criteria:

  1. Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
  2. Diagnosed with dementia (of any type);
  3. Had a stroke;
  4. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
  5. Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
  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): NCT01029171


Locations
Canada, British Columbia
Aging, Mobility, and Cognitive Neuroscience Laboratory, Vancouver Falls Prevention Clinic, University of British Columbia
Vancouver, British Columbia, Canada
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: Larry Dian, MD University of British Columbia
Study Director: Wendy Cook, MD 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01029171     History of Changes
Other Study ID Numbers: H04-70171
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by Teresa Liu-Ambrose, University of British Columbia:
falls
balance training
strength training