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

NCT05771818 | Unknown

• 1 other identifier: UR-0627-320
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Accidental Fall; Neurologic Disorder; Old Age; Debility; Healthy Aging

Keywords

Falls, Balance, Neurological, Geriatrics, Risk

Outcome Measures

Primary Outcomes (13)

• 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.

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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.

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• Changes in Anticipatory & Compensatory Postural Assessment from baseline to 1-year post

  Electromyography measure of postural stability in standing

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• 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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• Changes in falls occurrences from baseline to 1-year post

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

  Baseline, 6-weeks, 6-months and 1-year post intervention.

• Changes Physical Activity Intensity Monitoring from baseline to 1-year post intervention

  Heart rate monitoring during all components of falls prevention program

  Baseline, 6-weeks, 6-months and 1-year post intervention.

Study Arms (1)

Falls Prevention training

EXPERIMENTAL

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

Interventions

Falls Prevention Program 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.

Falls Prevention training

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of St. Augustine for Health Sciences: lead

Study Sites (1)

University of St Augustine for Health Science

Miami, Florida, 33134, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 16645293 RESULT

• 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.

  PMID: 18283231 RESULT

• 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.

  PMID: 27893567 RESULT

• 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.

  PMID: 29402651 RESULT

• 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.

  PMID: 29661594 RESULT

• 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.

  PMID: 26099794 RESULT

• 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.

  PMID: 21704329 RESULT

• 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.

  PMID: 20626698 RESULT

• 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.

  PMID: 26891642 RESULT

MeSH Terms

Conditions

Nervous System Diseases; Frailty; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Miguel Garcia, PT, DPT, EdD

  University of St. Augustine for Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Garcia, PT, DPT, EdD

CONTACT

786-725-4047; mgarcia@usa.edu

Gabriel Somarriba, PT, DPT, EdD

CONTACT

786-725-4010; gsomarriba@usa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: August 13, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)