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.
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
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.
- Conditions
- Postural Balance
- 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 group | Role | What they receive |
|---|---|---|
| Fall Prevention Exercises | Experimental | Participant 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 brochure | Other | Participant 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.
Change from Baseline in Tinetti Gait and Balance Score at 6 months
Measured: 6 months
Secondary outcomes (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.
- First posted28 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Maine
- Sponsor type
- University, hospital or other
- Collaborators
- University of New England, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lenard W. Kaye, University of Maine
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balancing Act: Impact on Falls in Older Adults With Vision Impairment
- ClinicalTrials.gov ID
- NCT02074488
- Acronym / sponsor ID
- 1R21AG045661-01
- Conditions
- Postural Balance
- Keywords
- balance, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MaineUniversity, hospital or other
- Collaborators
- University of New England, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Feb 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fall Prevention Exercises | Experimental | Other: Balancing Act exercise curriculum, Other: Informational BrochureParticipant provided with Balancing Act exercise curriculum for completion at least fifteen minutes three times a week over a six month period. |
| Informational brochure | Other | Other: Informational BrochureParticipant receives an informational brochure and orientation to brochure contents. |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balancing Act exercise curriculumBalance improvement exercise curriculum titled "Balancing Act" | Other | Fall Prevention Exercises |
| Informational BrochureInformational Brochure on falls prevention | Other | Fall Prevention Exercises, Informational brochure |
Primary outcome
Change from Baseline in Tinetti Gait and Balance Score at 6 months
Time frame: 6 months
1 secondary outcome
Change from Baseline in Tinetti Gait and Balance Score at 4 months
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Related trials for Postural Balance
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
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.