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

NCT ID: NCT05771818

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-13

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Accidental Fall Neurologic Disorder Old Age; Debility Healthy Aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Falls Prevention Program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of St. Augustine for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miguel Garcia, PT, DPT, EdD

Role: PRINCIPAL_INVESTIGATOR

University of St. Augustine for Health Sciences

Locations

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University of St Augustine for Health Science

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Miguel Garcia, PT, DPT, EdD

Role: CONTACT

786-725-4047

Gabriel Somarriba, PT, DPT, EdD

Role: CONTACT

786-725-4010

Facility Contacts

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Gabriel Somarriba, EdD

Role: primary

786-725-4045 ext. 4145

Miguel Garcia, EdD

Role: backup

786-725-4047 ext. 4147

References

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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.

Reference Type RESULT
PMID: 16645293 (View on PubMed)

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.

Reference Type RESULT
PMID: 18283231 (View on PubMed)

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.

Reference Type RESULT
PMID: 27893567 (View on PubMed)

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.

Reference Type RESULT
PMID: 29402651 (View on PubMed)

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.

Reference Type RESULT
PMID: 29661594 (View on PubMed)

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.

Reference Type RESULT
PMID: 26099794 (View on PubMed)

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.

Reference Type RESULT
PMID: 21704329 (View on PubMed)

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.

Reference Type RESULT
PMID: 20626698 (View on PubMed)

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.

Reference Type RESULT
PMID: 26891642 (View on PubMed)

Other Identifiers

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UR-0627-320

Identifier Type: -

Identifier Source: org_study_id

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