NCT01029171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

8.7 years

First QC Date

December 7, 2009

Last Update Submit

October 9, 2018

Conditions

Falls

Keywords

fallsbalance trainingstrength training

Outcome Measures

Primary Outcomes (1)

  • Falls over a 12 month period.

    12 months

Secondary Outcomes (1)

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

    12 months

Study Arms (2)

1

EXPERIMENTAL

OEP (Otago Exercise Program; home-based balance and strength retraining program)

Behavioral: Home-based balance and strength retraining exercise program.

2

ACTIVE COMPARATOR

CON (control; usual care)

Behavioral: control; usual care

Interventions

Home-based balance and strength retraining exercise program.BEHAVIORAL

A 12-month home-based balance and strength restraining program delivered by a physical therapist

1
control; usual careBEHAVIORAL

Usual care as prescribed by geriatrician.

2

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Adults older than or 70 years attending a Falls Prevention Clinic Service;
  • Understands, speaks, and reads English proficiently;
  • MMSE 8 score \> 24/30;
  • 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;
  • Expected to live greater than 12 months;
  • Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
  • Able to walk 3 meters with or without an assistive device; and
  • Able to provide written informed consent.

You may not qualify if:

  • Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
  • Diagnosed with dementia (of any type);
  • Had a stroke;
  • Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
  • Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vancouver, British Columbia, Canada

Location

Related Publications (7)

  • Falck RS, Hsu CL, Davis JC, Rice J, Dao E, Dian L, Madden K, Skelton DA, Parmar N, Cook WL, Khan KM, Liu-Ambrose T. Effect of a home-based exercise program on subsequent falls among community-dwelling older adults with cognitive frailty: A sub-group analysis of a randomized controlled trial. Maturitas. 2025 Jan;191:108151. doi: 10.1016/j.maturitas.2024.108151. Epub 2024 Nov 7.

    PMID: 39561465DERIVED

  • 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.

    PMID: 35798988DERIVED

  • 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.

    PMID: 35442974DERIVED

  • 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.

    PMID: 33225343DERIVED

  • 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.

    PMID: 32472567DERIVED

  • 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.

    PMID: 31162569DERIVED

  • 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.

    PMID: 25873254DERIVED

Study Officials

  • Teresa Liu-Ambrose

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations

CA(1)