Action Seniors! Exercise to Prevent Falls

Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029171
• Other study ID #: H04-70171
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: July 2018

Study information

• Verified date: October 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 344
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Falls

Intervention

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

Locations

Country	Name	City	State
Canada	Aging, Mobility, and Cognitive Neuroscience Laboratory, Vancouver Falls Prevention Clinic, University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls over a 12 month period.		12 months
Secondary	Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation.		12 months