Action Seniors! Exercise to Prevent Falls

This study is currently recruiting participants.

Verified February 2012 by University of British Columbia

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2009

Last Updated Date

February 28, 2012

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Falls over a 12 month period. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01029171 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Action Seniors! Exercise to Prevent Falls

Official Title ^ICMJE

"Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls.

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Falls

Intervention ^ICMJE

Behavioral: Home-based balance and strength retraining exercise program.
A 12-month home-based balance and strength restraining program delivered by a physical therapist
Behavioral: control; usual care
Usual care as prescribed by geriatrician.

Study Arm (s)

Experimental: 1
OEP (Otago Exercise Program; home-based balance and strength retraining program)

Intervention: Behavioral: Home-based balance and strength retraining exercise program.
Active Comparator: 2
CON (control; usual care)

Intervention: Behavioral: control; usual care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

344

Estimated Completion Date

July 2016

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

70 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jenna Homer

604 875 4111 ext 66459

jenna.homer@hiphealth.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01029171

Other Study ID Numbers ^ICMJE

H04-70171

Has Data Monitoring Committee

Yes

Responsible Party

University of British Columbia

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)

Investigators ^ICMJE

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

Information Provided By

University of British Columbia

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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