NCT02949986

Brief Summary

There are many exercise approaches that have demonstrated effectiveness in reducing falls and fall risk in community-dwelling older adults. The Otago Exercise Program is one such program. The Otago Exercise Program has been tested in four randomized controlled trials and one controlled multi-center trial and was found to reduce falls in older men and women. The focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The goal of the current study is to evaluate whether a self-administered, tablet-based version of the Otago fall prevention program is both feasible and effective for reducing fall risk and improving balance in community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

October 27, 2016

Last Update Submit

March 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Activity-specific balance confidence (ABC)

    ABC is a 16-item questionnaire regarding confidence to perform different activities (e.g., walking around the house, up and down stairs, and on icy surfaces) without losing balance. The scale ranges from 0% (no confidence at all) to 100% (completely confident). An overall average balance confidence score will be calculated for each subject.

    2 months

Secondary Outcomes (7)

  • Timed up and go test (TUG)

    2 months

  • Functional Gait Assessment (FGA)

    2 months

  • Preferred gait speed

    2 months

  • Single Leg Stance Test

    2 months

  • Modified clinical test of sensory interaction on balance (mCTSIB)

    2 months

  • +2 more secondary outcomes

Study Arms (1)

Tablet-based Fall Prevention

EXPERIMENTAL

The exercise program will be self-administered via a tablet-based version of the fall prevention program and the exercises performed in the home.

Behavioral: Tablet-based Fall Prevention

Interventions

The focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The program will be self-administered via tablet-based version of the Otago fall prevention program. Participants will complete 2 months of the home-based balance exercise program using the Health in Motion app. Participants will be asked to perform the exercises for 30 minutes 3x/week. Participants will be asked to perform the exercise program for 2 months.

Tablet-based Fall Prevention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age at least 60 years, ability to ambulate household distance without an assistive device; and ability to stand independently for twenty minutes

You may not qualify if:

  • cognitive impairment (based on Mini Mental Status Exam), unstable medical condition, progressive neurological condition, severe pain with weight bearing, and severe vision impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

Study Officials

  • Courtney Hall, PhD

    East Tennessee State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2016

First Posted

October 31, 2016

Study Start

August 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations