Action Seniors! Exercise to Prevent Falls

October 9, 2018 updated by: Teresa Liu-Ambrose, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Aging, Mobility, and Cognitive Neuroscience Laboratory, Vancouver Falls Prevention Clinic, University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Falls over a 12 month period.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H04-70171

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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