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

Primary Purpose

Accidental Fall, Neurologic Disorder, Old Age; Debility

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Falls Prevention Program
Sponsored by
University of St. Augustine for Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Accidental Fall focused on measuring Falls, Balance, Neurological, Geriatrics, Risk

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of St Augustine for Health ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Falls Prevention training

Arm Description

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

Outcomes

Primary Outcome Measures

Changes over time in Activities-Specific Balance Confidence Scale from baseline to one year
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.
Changes in Falls Efficacy Scale - International from baseline to 1-year post
A self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population
Changes in Berg Balance Test from baseline to 1-year post
The Berg Balance Test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Changes in Functional Reach Test from baseline to 1-year post
The Functional Reach measures the participant to complete a forward reach while in a standing position
Changes in Single Limb Stance from baseline to 1-year post
The Single Limb Stance test is a measurement to assess the individual's ability to stand unsupported on one limb.
Changes in Tandem Stance from baseline to 1-year post
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
Changes in 10-Meter Walk Test from baseline to 1-year post
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Changes in 6-Minute Walk Test from baseline to 1-year post
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance
Changes in Timed Up and Go from baseline to 1-year post
The Timed Up and Go test is a measure that assess fall risk by performing sit to stand and walking
Changes in Anticipatory & Compensatory Postural Assessment from baseline to 1-year post
Electromyography measure of postural stability in standing
Changes in Obstacle Course performance from baseline to 1-year post
The obstacle course measures time to complete 17 obstacles and errors performed on each of the obstacles
Changes in falls occurrences from baseline to 1-year post
The questionnaire assesses incidence of falls, falls with injuries and falls requiring hospitalization
Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
Heart rate monitoring during all components of falls prevention program

Secondary Outcome Measures

Full Information

First Posted
March 5, 2023
Last Updated
March 5, 2023
Sponsor
University of St. Augustine for Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05771818
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of St. Augustine for Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Fall, Neurologic Disorder, Old Age; Debility, Healthy Aging
Keywords
Falls, Balance, Neurological, Geriatrics, Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Falls Prevention training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Falls Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes over time in Activities-Specific Balance Confidence Scale from baseline to one year
Description
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.
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Falls Efficacy Scale - International from baseline to 1-year post
Description
A self-administered questionnaire designed to assess fear of falling in mainly community-dwelling older population
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Berg Balance Test from baseline to 1-year post
Description
The Berg Balance Test is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Functional Reach Test from baseline to 1-year post
Description
The Functional Reach measures the participant to complete a forward reach while in a standing position
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Single Limb Stance from baseline to 1-year post
Description
The Single Limb Stance test is a measurement to assess the individual's ability to stand unsupported on one limb.
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Tandem Stance from baseline to 1-year post
Description
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
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in 10-Meter Walk Test from baseline to 1-year post
Description
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in 6-Minute Walk Test from baseline to 1-year post
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Timed Up and Go from baseline to 1-year post
Description
The Timed Up and Go test is a measure that assess fall risk by performing sit to stand and walking
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Anticipatory & Compensatory Postural Assessment from baseline to 1-year post
Description
Electromyography measure of postural stability in standing
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in Obstacle Course performance from baseline to 1-year post
Description
The obstacle course measures time to complete 17 obstacles and errors performed on each of the obstacles
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes in falls occurrences from baseline to 1-year post
Description
The questionnaire assesses incidence of falls, falls with injuries and falls requiring hospitalization
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.
Title
Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention
Description
Heart rate monitoring during all components of falls prevention program
Time Frame
Baseline, 6-weeks, 6-months and 1-year post intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Garcia, PT, DPT, EdD
Phone
786-725-4047
Email
mgarcia@usa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Somarriba, PT, DPT, EdD
Phone
786-725-4010
Email
gsomarriba@usa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Garcia, PT, DPT, EdD
Organizational Affiliation
University of St. Augustine for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of St Augustine for Health Science
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Somarriba, EdD
Phone
786-725-4045
Ext
4145
Email
gsomarriba@usa.edu
First Name & Middle Initial & Last Name & Degree
Miguel Garcia, EdD
Phone
786-725-4047
Ext
4147
Email
mgarcia@usa.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16645293
Citation
Weerdesteyn V, Rijken H, Geurts AC, Smits-Engelsman BC, Mulder T, Duysens J. A five-week exercise program can reduce falls and improve obstacle avoidance in the elderly. Gerontology. 2006;52(3):131-41. doi: 10.1159/000091822.
Results Reference
result
PubMed Identifier
18283231
Citation
Rosendahl E, Gustafson Y, Nordin E, Lundin-Olsson L, Nyberg L. A randomized controlled trial of fall prevention by a high-intensity functional exercise program for older people living in residential care facilities. Aging Clin Exp Res. 2008 Feb;20(1):67-75. doi: 10.1007/BF03324750.
Results Reference
result
PubMed Identifier
27893567
Citation
Gallo E, Stelmach M, Frigeri F, Ahn DH. Determining Whether a Dosage-Specific and Individualized Home Exercise Program With Consults Reduces Fall Risk and Falls in Community-Dwelling Older Adults With Difficulty Walking: A Randomized Control Trial. J Geriatr Phys Ther. 2018 Jul/Sep;41(3):161-172. doi: 10.1519/JPT.0000000000000114.
Results Reference
result
PubMed Identifier
29402651
Citation
Hewitt J, Goodall S, Clemson L, Henwood T, Refshauge K. Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program. J Am Med Dir Assoc. 2018 Apr;19(4):361-369. doi: 10.1016/j.jamda.2017.12.014.
Results Reference
result
PubMed Identifier
29661594
Citation
Gudnadottir M, Thorsteinsdottir TK, Mogensen B, Aspelund T, Thordardottir EB. Accidental injuries among older adults: An incidence study. Int Emerg Nurs. 2018 Sep;40:12-17. doi: 10.1016/j.ienj.2018.03.003. Epub 2018 Apr 13.
Results Reference
result
PubMed Identifier
26099794
Citation
Stewart Williams J, Kowal P, Hestekin H, O'Driscoll T, Peltzer K, Yawson A, Biritwum R, Maximova T, Salinas Rodriguez A, Manrique Espinoza B, Wu F, Arokiasamy P, Chatterji S; SAGE collaborators. Prevalence, risk factors and disability associated with fall-related injury in older adults in low- and middle-incomecountries: results from the WHO Study on global AGEing and adult health (SAGE). BMC Med. 2015 Jun 23;13:147. doi: 10.1186/s12916-015-0390-8.
Results Reference
result
PubMed Identifier
21704329
Citation
Oyetunji TA, Ong'uti SK, Bolorunduro OB, Gonzalez DO, Cornwell EE, Haider AH. Epidemiologic trend in elderly domestic injury. J Surg Res. 2012 Apr;173(2):206-11. doi: 10.1016/j.jss.2011.05.003. Epub 2011 May 31.
Results Reference
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PubMed Identifier
20626698
Citation
Saveman BI, Bjornstig U. Unintentional injuries among older adults in northern Sweden--a one-year population-based study. Scand J Caring Sci. 2011 Mar;25(1):185-93. doi: 10.1111/j.1471-6712.2010.00810.x.
Results Reference
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PubMed Identifier
26891642
Citation
Scariot V, Rios JL, Claudino R, Dos Santos EC, Angulski HBB, Dos Santos MJ. Both anticipatory and compensatory postural adjustments are adapted while catching a ball in unstable standing posture. J Bodyw Mov Ther. 2016 Jan;20(1):90-97. doi: 10.1016/j.jbmt.2015.06.007. Epub 2015 Jun 19.
Results Reference
result

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

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