Action Seniors! Exercise to Prevent Falls

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01029171
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 344
• Location: 1
• Arms: 2
• Duration (Months): 104
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Falls	Behavioral: Home-based balance and strength retraining exercise program.; Behavioral: control; usual care	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 344 participants
• 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.
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Falls over a 12 month period. [12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

1. 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;

1. Expected to live greater than 12 months;

2. Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);

3. Able to walk 3 meters with or without an assistive device; and

4. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01029171
• Other Study ID Numbers: H04-70171
• First Posted: Dec 9, 2009
• Last Update Posted: Oct 10, 2018
• Last Verified: Oct 1, 2018

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

Study Results

No Results Posted as of Oct 10, 2018