Clinical trial NCT01029171: Action Seniors! Exercise to Prevent Falls
Official title: "Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Keywords: falls
balance training
strength training
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-12-09
Enrollment: 344
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Falls over a 12 month period.
timeFrame: 12 months
Secondary outcomes:
measure: Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation.
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Aging, Mobility, and Cognitive Neuroscience Laboratory, Vancouver Falls Prevention Clinic, University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Teresa Liu-Ambrose
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Karim Khan, Ph.D
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Larry Dian, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Wendy Cook, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Penny Brasher, Ph.D
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Carlo Marra, Ph.D
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Jennifer Davis, Ph.D
role: STUDY_DIRECTOR
References:
citation: Davis JC, Hsu CL, Ghag C, Starkey SY, Jacova P, Dian L, Parmar N, Madden K, Liu-Ambrose T. Baseline health-related quality of life predicts falls: a secondary analysis of a randomized controlled trial. Qual Life Res. 2022 Nov;31(11):3211-3220. doi: 10.1007/s11136-022-03175-2. Epub 2022 Jul 7.
citation: Davis JC, Hsu CL, Barha C, Jehu DA, Chan P, Ghag C, Jacova P, Adjetey C, Dian L, Parmar N, Madden K, Liu-Ambrose T. Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial. PLoS One. 2022 Apr 20;17(4):e0267247. doi: 10.1371/journal.pone.0267247. eCollection 2022.
citation: Liu-Ambrose T, Davis JC, Falck RS, Best JR, Dao E, Vesely K, Ghag C, Rosano C, Hsu CL, Dian L, Cook W, Madden KM, Khan KM. Exercise, Processing Speed, and Subsequent Falls: A Secondary Analysis of a 12-Month Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2021 Mar 31;76(4):675-682. doi: 10.1093/gerona/glaa239.
citation: Davis JC, Khan KM, Hsu CL, Chan P, Cook WL, Dian L, Liu-Ambrose T. Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers. J Am Geriatr Soc. 2020 Sep;68(9):1988-1997. doi: 10.1111/jgs.16476. Epub 2020 May 29.
citation: Liu-Ambrose T, Davis JC, Best JR, Dian L, Madden K, Cook W, Hsu CL, Khan KM. Effect of a Home-Based Exercise Program on Subsequent Falls Among Community-Dwelling High-Risk Older Adults After a Fall: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2092-2100. doi: 10.1001/jama.2019.5795.
citation: Liu-Ambrose T, Davis JC, Hsu CL, Gomez C, Vertes K, Marra C, Brasher PM, Dao E, Khan KM, Cook W, Donaldson MG, Rhodes R, Dian L. Action seniors! - secondary falls prevention in community-dwelling senior fallers: study protocol for a randomized controlled trial. Trials. 2015 Apr 10;16:144. doi: 10.1186/s13063-015-0648-7.