Clinical trial NCT05771818: A Community-Based Falls Prevention Program for Adults At-Risk for Falls
Official title: A Community-Based Falls Prevention Program for Adults At-Risk for Falls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accidental Fall
Neurologic Disorder
Old Age; Debility
Healthy Aging
Keywords: Falls, Balance, Neurological, Geriatrics, Risk
Lead sponsor: University of St. Augustine for Health Sciences
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to implement a Falls Prevention Program to impact the risk and injuries related to falls. The main question is to learn and examine the effects of a falls prevention program on the functional mobility of adults at risk for falls.

Participants will:

* Complete functional mobility assessments
* Complete Falls prevention obstacle course training
* Complete Falls Strategies Training
* Complete walking and balance training

Detailed description: The purpose of the study is to implement a Fall Prevention Program to impact the risk and injuries related to falls. This study is innovative in that (1) it will be implemented as a community service program for the first time in the United States (2) it will attempt to standardize an obstacle course as a reliable and valid outcome measure for balance and falls (3) it will incorporate community outreach learning opportunity for students in a doctor of physical therapy curriculum at the University of St. Augustine for Health Sciences and (4) it will assess effectiveness using a variety of standardized and valid outcome measures to address balance and coordination deficits, fear of falling, incidence of falling, gait speed, feasibility and patient perception and satisfaction.

Specific Aim 1: To examine the effects of a falls prevention program on the functional mobility of adults at risk for falls. Hypothesis: Physical exercise and dynamic balance training has been shown to be effective in decreasing risk for falls. The Falls Prevention Program will have a positive effect on balance, gait speed, fear of falls, incidence of falls and incorporation of falls techniques.

Specific Aim 2: To create a falls prevention program within a Doctor of Physical Therapy curriculum. Hypothesis: Community outreach which are learning opportunities that benefit the community at large are part of the Doctor of Physical Therapy curriculum. It is expected that the Falls Prevention Program will be successfully integrated into the Geriatric Rehabilitation for Physical Therapy course with appropriate participation from the students.

Specific Aim 3: Evaluate the reliability and validity of an obstacle course as a measure of fall risk. Hypothesis: The Falls Prevention Program includes a 17-item obstacle course that significantly challenges the participant's functional mobility and standing dynamic balance. It is expected that the obstacle course will serve as a reliable and valid test for the assessment for balance and mobility.

Specific Aim 4: Evaluate the acceptability of a Falls Prevention Program. Hypothesis: There are no current falls prevention programs available to the community as a free community service program. It is believed that the program will be accepted by the community as well as the faculty and students leading the program.

Specific Aim 5: Determine whether disease moderates the relationship between the effects of a Falls Prevention Program and functional mobility of adults at risk for falls. Hypothesis: Fall Prevention Programs to improve balance and functional mobility have been effective for participants at risk for falls. This program will aim to assess the impact a Falls Prevention Program has on different populations.

Specific Aim 6: Determine the effects of the Falls Prevention Program on Anticipatory Postural Assessment and Compensatory Postural Assessment.

Hypothesis: Older adults will improve their Anticipatory Postural Assessment and Compensatory Postural Assessment (less magnitude and faster responses of muscle activity along with less body displacement) in response to balance perturbations a a result of the intervention.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age range: 18-100
* At risk for falls (as determined by any of the following:
* Positive history of falls within 5 years
* Timed up and Go \<45 seconds
* Medical clearance for participation in Falls Prevention Program
* Able to attend biweekly sessions for 5 weeks

Exclusion Criteria:

* Unable to independently kneel and sit and on the floor and return to chair
* Taking prescription anti-coagulants without physician clearance to participate
* No medical clearance for participation in Falls Prevention Program
* Unable to attend bi-weekly on-site sessions for 5 weeks
* Other reasons that may limit participation in intervention

Primary outcomes:
measure: Changes over time in Activities-Specific Balance Confidence Scale from baseline to one year
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Falls Efficacy Scale - International from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Berg Balance Test from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Functional Reach Test from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Single Limb Stance from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Tandem Stance from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in 10-Meter Walk Test from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in 6-Minute Walk Test from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Timed Up and Go from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Anticipatory & Compensatory Postural Assessment from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in Obstacle Course performance from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes in falls occurrences from baseline to 1-year post
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
measure: Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
timeFrame: Baseline, 6-weeks, 6-months and 1-year post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of St Augustine for Health Science
state: Florida
Study officials:
affiliation: University of St. Augustine for Health Sciences
name: Miguel Garcia, PT, DPT, EdD
role: PRINCIPAL_INVESTIGATOR
References:
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