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Balancing Act: Impact on Falls in Older Adults With Vision Impairment

NCT ID: NCT02074488

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

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Falls are a significant issue for older adults with vision impairment. Medical conditions such as glaucoma and age-related macular degeneration that result in vision impairment negatively impact balance. Falling is 1.7 times more likely among older adults with vision impairment. In 2010 there were 9,146,026 older adults treated in emergency rooms for unintentional falls and injuries from falls are expected to cost the nation an estimated $54.9 billion dollars by 2020. Falls can lead to death, depression, and loss of independence. However, impaired balance is a modifiable risk factor for falls. A practical yet innovative falls prevention program has been developed that is designed to enhance balance and proprioception among older adults. This program, UExCEL (UNE-Exercise and Conditioning for Easier Living) Balancing Act, consists of simple exercises that can be done at home (15 minutes duration-3 times a week) during normal daily activities, requires only one brief training session, and no equipment. This study aims to establish an evidence base documenting the positive impact of Balancing Act exercises on balance and falls prevention for older adults with vision impairment. A randomized controlled trial of older adults with vision impairment (best corrected vision of 20/70 or worse) will be conducted over a 6-month period (control group n = 35 and Balancing Act intervention group n = 35) to determine the impact of Balancing Act on falls, fear of falling, pain, and activity levels. Factors that can be expected to affect its adoption and sustained use such as cost in the community and social support networks in the home will also be investigated. It is hypothesized that the Balancing Act intervention will decrease the number of falls experienced by older adults who have vision impairment by improving their gait and balance, reducing their fear of falling, increasing their physical activity, and reducing their pain.

The specific aims of the research are to: 1) Evaluate the impact of Balancing Act on standing balance control and proprioception for older adults who have vision impairment, using the Tinetti Gait \& Balance Test, a validated tool for evaluating gait and balance and predicting fall risk; 2) Evaluate the impact of Balancing Act for older adults with vision impairment on falls, fear of falling, physical activity, and pain; and 3) Improve adherence to the Balancing Act exercise program by facilitating social networks. Data will be analyzed through: 1) a descriptive assessment of the baseline demographic characteristics of sample members, covariates, and outcome variables, as well as 2) a repeated measures design examining the impact of the intervention on study participants.

Detailed Description

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Conditions

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Postural Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fall Prevention Exercises

Participant provided with Balancing Act exercise curriculum for completion at least fifteen minutes three times a week over a six month period.

Group Type EXPERIMENTAL

Balancing Act exercise curriculum

Intervention Type OTHER

Balance improvement exercise curriculum titled "Balancing Act"

Informational Brochure

Intervention Type OTHER

Informational Brochure on falls prevention

Informational brochure

Participant receives an informational brochure and orientation to brochure contents.

Group Type OTHER

Informational Brochure

Intervention Type OTHER

Informational Brochure on falls prevention

Interventions

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Balancing Act exercise curriculum

Balance improvement exercise curriculum titled "Balancing Act"

Intervention Type OTHER

Informational Brochure

Informational Brochure on falls prevention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 62 years or older
* Individual resides in his/her own home/apartment
* Best corrected vision of 20/70 or worse
* Is able to follow one step commands
* Individual is able to provide informed consent
* Individual can ambulate at least 200 feet (may use assistive devices)
* Score on Timed Get Up and Go test is equal to or greater than 12 seconds

Exclusion Criteria

* Less than 62 years of age
* Individual does not reside in his/her own home/apartment
* Best corrected vision is better than 20/70
* Is not able to follow one step commands
* Is not able to provide informed consent
* Individual cannot ambulate at least 200 feet
* Score on Timed Get Up and Go test is less than 12 seconds
Minimum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New England

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Maine

OTHER

Sponsor Role lead

Responsible Party

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Lenard W. Kaye

Director, UMaine Center on Aging; Professor, UMaine School of Social Work

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of New England

Biddeford, Maine, United States

Site Status

University of Maine

Orono, Maine, United States

Site Status

The Iris Network

Portland, Maine, United States

Site Status

Countries

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United States

Other Identifiers

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1R21AG045661-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R21AG045661-01

Identifier Type: NIH

Identifier Source: org_study_id

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