Clinical trial NCT03176511: Fall Prevention in Older Adults Study
Official title: Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Postural Balance
Keywords: older adults
dual task
A Matter of Balance
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed pilot study will employ a single-blind, two-group randomized clinical trial. We will randomly assign 24 community-dwelling older adults (≥ 60 years) from an underserved population who are at high fall risk to either: A.) 4-week MOB+DTBC intervention, or B.) 4-week MOB only intervention (n=12/group).
Primary purpose: TREATMENT

Brief summary: Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. We are testing to see if adding a dual-task balance component (balance and mental thinking) to MOB can improve balance and walking better, than MOB only.

Detailed description: Fall prevention interventions among community-dwelling older adults are essential. A Matter of Balance (MOB) is one of the most commonly used community-based fall prevention interventions nationally, and is considered the 'fall prevention standard of care'. MOB programs are targeted to reduce the fear of falling and promote physical activity among all older community-dwelling adults. While evidence indicates that the MOB program leads to small, sustained decreases in older adults' perceived fear of falling, there is no evidence of objectively measured balance and gait. Despite its name, MOB focuses on cognitive restructuring to manage concerns about falling, and does not include a balance component. Among community-dwelling older adults, both intact balance and concomitant attention ("dual-tasking") are essential to prevent falls, and dual-task balance components are now requisite per evidence-based fall prevention intervention guidelines.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults from all sex/gender and racial/ethnic groups, aged ≥ 60 years, at high fall risk (FRQ=Fall Risk Questionnaire score \> 4), who live in the greater Tucson, AZ area.

Exclusion Criteria:

* Older adults currently attending MOB or other fall prevention classes (e.g. Fall Proof), having a severe mobility disorder (e.g., unable to walk 15 feet with an assistive device), severe visual or hearing impairment, non-English speaking, lack of decision-making capacity, unable to provide informed consent, serious psychiatric disorder (e.g., schizophrenia), moderately-severe depression (PHQ-9=Patient Health Questionnaire ≥ 15), cognitive impairment (MMSE=Mini-Mental Status Exam ≤ 23), or serious medical condition (e.g., cancer treatments).

Primary outcomes:
measure: Balance
timeFrame: Data will be collected at baseline and post-intervention at 4 weeks.
Secondary outcomes:
measure: Gait
timeFrame: Data will be collected at baseline and post-intervention at 4 weeks.
measure: Fear of Falling
timeFrame: Data will be collected at baseline and post-intervention at 4 weeks.
measure: 3-month incident Fall Rates
timeFrame: Data will be collected post-intervention at months 1, 2 and 3.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: El Rio Community Health Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Ruth E Taylor-Piliae, PhD
role: PRINCIPAL_INVESTIGATOR
References: