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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01029171 |
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Date of registration:
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07/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Action Seniors! Exercise to Prevent Falls
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Scientific title:
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"Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls. |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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344 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01029171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Larry Dian, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Teresa Liu-Ambrose |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Wendy Cook, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Carlo Marra, Ph.D |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Jennifer Davis, Ph.D |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Karim Khan, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Penny Brasher, Ph.D |
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Address:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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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).
Age minimum:
70 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Falls
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Intervention(s)
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Behavioral: control; usual care
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Behavioral: Home-based balance and strength retraining exercise program.
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Primary Outcome(s)
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Falls over a 12 month period.
[Time Frame: 12 months]
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Secondary Outcome(s)
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Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation.
[Time Frame: 12 months]
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Secondary ID(s)
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H04-70171
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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