Does Participation in a Fall Preparedness Program Improve Fall Efficacy Among Older Adults

NCT06545539 | Not Yet Recruiting

• 1 other identifier: 2025-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if a fall preparedness program can reduce the fear of falling in older adults and subsequently improve their function and reduce falls with injury. Participants will perform baseline measures 4 weeks before intervention and again at the start of intervention. They will perform a 12-week intervention and then complete outcome measures again at the conclusion of the program.

Conditions

Fall Injury; Fall; Falls (Accidents) in Old Age

Outcome Measures

Primary Outcomes (1)

• Fall Efficacy Scale International (FES-I)

  Measure of self reported fall efficacy

  4 weeks before start of intervention through completion of intervention; approximately 15 weeks

Secondary Outcomes (2)

• short physical performance battery (SPPB)

  4 weeks before start of intervention through completion of intervention; approximately 15 weeks

• Physical Activity Scale for the Elderly (PASE)

  4 weeks before start of intervention through completion of intervention; approximately 15 weeks

Other Outcomes (1)

• Six-item cognitive impairment test (6CIT)

  4 weeks before start of intervention

Study Arms (1)

Fall Preparedness Class Participants

EXPERIMENTAL

Participants who meet inclusion and exclusion requirements of the study and sign an informed consent.

Other: Fall Preparedness Exercise Class

Interventions

Fall Preparedness Exercise Class OTHER

The class will be held bi-weekly at two different locations. To ensure consistency across groups, the instructor(s) will adhere to a standardized class outline. Exercise modifications will be provided as necessary to adjust the intensity, ensuring all participants can follow the program.

Fall Preparedness Class Participants

Eligibility Criteria

• Age: 60 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 60 and up
• able to participate in exercise program

You may not qualify if:

• Adults age \<60 year old
• severe medical condition that prohibits the ability to participate in an exercise program
• CIT score that indicates severely impaired cognition.
• Severe medical conditions will be screed by a licensed Physical Therapist. Under the Ohio Practice Act, physical therapists in Ohio are permitted to differently diagnosis. The class participants will be community-dwelling older adults who are less likely to come to participate in an exercise class if they have any severe medical conditions.
• Any participants with mild cognitive impairment who are not excluded from the study will be offered simplified instructions by the licensed physical therapist performing the assessments. They will also be offered increased verbal, visual, and tactile cues as needed throughout the program to ensure understanding.

Sponsors & Collaborators

• Youngstown State University: lead
• YMCA: collaborator

Study Sites (2)

YMCA

Boardman, Ohio, 44512, United States

Location

Youngstown State University

Youngstown, Ohio, 44555-0001, United States

Location

Related Publications (14)

• Feng C, Adebero T, DePaul VG, Vafaei A, Norman KE, Auais M. A Systematic Review and Meta-Analysis of Exercise Interventions and Use of Exercise Principles to Reduce Fear of Falling in Community-Dwelling Older Adults. Phys Ther. 2022 Jan 1;102(1):pzab236. doi: 10.1093/ptj/pzab236.

  PMID: 34636923 BACKGROUND

• Liu M, Hou T, Li Y, Sun X, Szanton SL, Clemson L, Davidson PM. Fear of falling is as important as multiple previous falls in terms of limiting daily activities: a longitudinal study. BMC Geriatr. 2021 Jun 7;21(1):350. doi: 10.1186/s12877-021-02305-8.

  PMID: 34098904 BACKGROUND

• de Souza LF, Canever JB, Moreira BS, Danielewicz AL, de Avelar NCP. Association Between Fear of Falling and Frailty in Community-Dwelling Older Adults: A Systematic Review. Clin Interv Aging. 2022 Feb 9;17:129-140. doi: 10.2147/CIA.S328423. eCollection 2022.

  PMID: 35173427 BACKGROUND

• Kumar A, Delbaere K, Zijlstra GA, Carpenter H, Iliffe S, Masud T, Skelton D, Morris R, Kendrick D. Exercise for reducing fear of falling in older people living in the community: Cochrane systematic review and meta-analysis. Age Ageing. 2016 May;45(3):345-52. doi: 10.1093/ageing/afw036.

  PMID: 27121683 BACKGROUND

• Schmid AA, Van Puymbroeck M, Koceja DM. Effect of a 12-week yoga intervention on fear of falling and balance in older adults: a pilot study. Arch Phys Med Rehabil. 2010 Apr;91(4):576-83. doi: 10.1016/j.apmr.2009.12.018.

  PMID: 20382290 BACKGROUND

• Zijlstra GA, van Haastregt JC, van Rossum E, van Eijk JT, Yardley L, Kempen GI. Interventions to reduce fear of falling in community-living older people: a systematic review. J Am Geriatr Soc. 2007 Apr;55(4):603-15. doi: 10.1111/j.1532-5415.2007.01148.x.

  PMID: 17397441 BACKGROUND

• Chua CHM, Jiang Y, Lim S, Wu VX, Wang W. Effectiveness of cognitive behaviour therapy-based multicomponent interventions on fear of falling among community-dwelling older adults: A systematic review and meta-analysis. J Adv Nurs. 2019 Dec;75(12):3299-3315. doi: 10.1111/jan.14150. Epub 2019 Aug 27.

  PMID: 31287182 BACKGROUND

• Yoshikawa A, Ramirez G, Smith ML, Lee S, Ory MG. Systematic review and meta-analysis of fear of falling and fall-related efficacy in a widely disseminated community-based fall prevention program. Arch Gerontol Geriatr. 2020 Nov/Dec;91:104235. doi: 10.1016/j.archger.2020.104235. Epub 2020 Aug 18.

  PMID: 32911232 BACKGROUND

• Moon Y, Sosnoff JJ. Safe Landing Strategies During a Fall: Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Apr;98(4):783-794. doi: 10.1016/j.apmr.2016.08.460. Epub 2016 Aug 31.

  PMID: 27592402 BACKGROUND

• Arkkukangas M, Stromqvist Baathe K, Ekholm A, Tonkonogi M. High Challenge Exercise and Learning Safe Landing Strategies among Community-Dwelling Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jun 16;19(12):7370. doi: 10.3390/ijerph19127370.

  PMID: 35742618 BACKGROUND

• Groen BE, Smulders E, de Kam D, Duysens J, Weerdesteyn V. Martial arts fall training to prevent hip fractures in the elderly. Osteoporos Int. 2010 Feb;21(2):215-21. doi: 10.1007/s00198-009-0934-x. Epub 2009 May 1.

  PMID: 19407919 BACKGROUND

• Swancutt DR, Hope SV, Kent BP, Robinson M, Goodwin VA. Knowledge, skills and attitudes of older people and staff about getting up from the floor following a fall: a qualitative investigation. BMC Geriatr. 2020 Oct 6;20(1):385. doi: 10.1186/s12877-020-01790-7.

  PMID: 33023509 BACKGROUND

• Ardali G, Brody LT, States RA, Godwin EM. Reliability and Validity of the Floor Transfer Test as a Measure of Readiness for Independent Living Among Older Adults. J Geriatr Phys Ther. 2019 Jul/Sep;42(3):136-147. doi: 10.1519/JPT.0000000000000142.

  PMID: 29059121 BACKGROUND

• Hauer KA, Kempen GI, Schwenk M, Yardley L, Beyer N, Todd C, Oster P, Zijlstra GA. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462-72. doi: 10.1159/000320054. Epub 2010 Oct 22.

  PMID: 20975251 BACKGROUND

Related Links

• statistics and facts about falls in the older adult population

Study Officials

• Shannon J Dudash

  Youngstown State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon J Dudash

CONTACT

3309412407; sstarr@ysu.edu

Weiqing Ge

CONTACT

3309412702; wge@ysu.edu

Study Design

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

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)