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Postural BalanceNCT02074488

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

A study testing Balancing Act exercise curriculum and Informational Brochure in people with Postural Balance, run by University of Maine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 62 years and older
Conditions the study is for
Postural Balance
What is being tested?
Balancing Act exercise curriculum and Informational Brochure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
3 sitesUnited States
Study dates
Feb 2014to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 62 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of New England

    Biddeford, Maine, 04005-9526

  • University of Maine

    Orono, Maine, 04469-5717

  • The Iris Network

    Portland, Maine, 04102-2909

Other trials in United States

About this study

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.

Being tested
Balancing Act exercise curriculum, Informational Brochure
Keywords
balance, gait

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balancing Act exercise curriculumOther

    Balance improvement exercise curriculum titled "Balancing Act"

  • Informational BrochureOther

    Informational Brochure on falls prevention

Study groups in NCT02074488
Study groupRoleWhat they receive
Fall Prevention ExercisesExperimentalParticipant provided with Balancing Act exercise curriculum for completion at least fifteen minutes three times a week over a six month period.
Receives: Other: Balancing Act exercise curriculum; Other: Informational Brochure
Informational brochureOtherParticipant receives an informational brochure and orientation to brochure contents.
Receives: Other: Informational Brochure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Tinetti Gait and Balance Score at 6 months

    Measured: 6 months

Secondary outcomes (1)
  1. Change from Baseline in Tinetti Gait and Balance Score at 4 months

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02074488
Sponsor's protocol ID
1R21AG045661-01
Other IDs
1R21AG045661-01
Status last verified
Dec 2015
First submitted
25 Feb 2014
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Balancing Act exercise curriculum and Informational Brochure in people with Postural Balance, run by University of Maine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Tinetti Gait and Balance Score at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.

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