A Community-Based Falls Prevention Program for Adults At-Risk for Falls

Sponsor
University of St. Augustine for Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05771818
Collaborator
(none)
150
1
1
64.6
2.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Falls Prevention Program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Community-Based Falls Prevention Program for Adults At-Risk for Falls
Actual Study Start Date :
Aug 13, 2020
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Falls Prevention training

The intervention consists of 10 sessions. One session a week consists of obstacle course training. The other session consists of falls strategies and walking and balance exercises. Each session lasts approximately 1.5 hours

Other: Falls Prevention Program
The intervention consists of 10 sessions. One session a week consists of obstacle course training. The other session focuses on falls strategies training and walking and balance exercises. Each session lasts approximately 1.5 hours.

Outcome Measures

Primary Outcome Measures

  1. Changes over time in Activities-Specific Balance Confidence Scale from baseline to one year [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The Activities-Specific Balance Confidence Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness.

  2. Changes in Falls Efficacy Scale - International from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    A self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population

  3. Changes in Berg Balance Test from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The Berg Balance Test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks

  4. Changes in Functional Reach Test from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The Functional Reach measures the participant to complete a forward reach while in a standing position

  5. Changes in Single Limb Stance from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The Single Limb Stance test is a measurement to assess the individual's ability to stand unsupported on one limb.

  6. Changes in Tandem Stance from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The Tandem Stance test is a measurement to assess the individual's ability to stand unsupported with one foot directly in front of the other

  7. Changes in 10-Meter Walk Test from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance

  8. Changes in 6-Minute Walk Test from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance

  9. Changes in Timed Up and Go from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The Timed Up and Go test is a measure that assess fall risk by performing sit to stand and walking

  10. Changes in Anticipatory & Compensatory Postural Assessment from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    Electromyography measure of postural stability in standing

  11. Changes in Obstacle Course performance from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The obstacle course measures time to complete 17 obstacles and errors performed on each of the obstacles

  12. Changes in falls occurrences from baseline to 1-year post [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    The questionnaire assesses incidence of falls, falls with injuries and falls requiring hospitalization

  13. Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention [Baseline, 6-weeks, 6-months and 1-year post intervention.]

    Heart rate monitoring during all components of falls prevention program

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of St Augustine for Health Science Miami Florida United States 33134

Sponsors and Collaborators

  • University of St. Augustine for Health Sciences

Investigators

  • Principal Investigator: Miguel Garcia, PT, DPT, EdD, University of St. Augustine for Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of St. Augustine for Health Sciences
ClinicalTrials.gov Identifier:
NCT05771818
Other Study ID Numbers:
  • UR-0627-320
First Posted:
Mar 16, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of St. Augustine for Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023