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

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ClinicalTrials.gov Identifier: NCT02074488
Recruitment Status : Completed
First Posted : February 28, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborators:
University of New England
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Lenard W. Kaye, University of Maine

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postural Balance Other: Balancing Act exercise curriculum Other: Informational Brochure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Balancing Act: Impact on Falls in Older Adults With Vision Impairment
Study Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: Balancing Act exercise curriculum
Balance improvement exercise curriculum titled "Balancing Act"

Other: Informational Brochure
Informational Brochure on falls prevention

Informational brochure
Participant receives an informational brochure and orientation to brochure contents.
Other: Informational Brochure
Informational Brochure on falls prevention




Primary Outcome Measures :
  1. Change from Baseline in Tinetti Gait and Balance Score at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from Baseline in Tinetti Gait and Balance Score at 4 months [ Time Frame: 4 months ]

Other Outcome Measures:
  1. Change from Baseline in Tinetti Gait and Balance Score at 2 months [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   62 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074488


Locations
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United States, Maine
University of New England
Biddeford, Maine, United States, 04005-9526
University of Maine
Orono, Maine, United States, 04469-5717
The Iris Network
Portland, Maine, United States, 04102-2909
Sponsors and Collaborators
University of Maine
University of New England
National Institutes of Health (NIH)
National Institute on Aging (NIA)

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Responsible Party: Lenard W. Kaye, Director, UMaine Center on Aging; Professor, UMaine School of Social Work, University of Maine
ClinicalTrials.gov Identifier: NCT02074488     History of Changes
Other Study ID Numbers: 1R21AG045661-01 ( U.S. NIH Grant/Contract )
1R21AG045661-01 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Lenard W. Kaye, University of Maine:
balance
gait