The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face

NCT05018455 | Completed

• 1 other identifier: Remote fall prevention
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

Falls are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large. This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. This study design is a randomized control trial (RCT) with a cross-over in group allocation. The population will include 106 home-dwelling elderly, aged 65 years or more, with low to moderate risk of fall. Participants will be randomized to start intervention in the remote or face-to-face group. Training will be twice weekly for 3 months, after which there will be two weeks of washout, followed by a cross-over between groups. Outcome measures will include fall rate over a year (primary measure), balance, functional testing, subjective measures of fear of falls, quality of life, satisfaction from intervention, adherence, and compliance.

Conditions

Fall

Keywords

Telehealth, fall prevention, home dwelling elderly, Otago

Outcome Measures

Primary Outcomes (1)

• Number of falls during the study period

  Subjects will self-report falls weekly in a personal fall diary. This will be supported by a telephone call from one of the investigators once a month.

  Falls will be monitored for one year

Secondary Outcomes (11)

• Mini Balance Evaluation Systems Tests

  Change from baseline at 3, 6 and 12 months

• Time-Up and Go Test

  Change from baseline at 3, 6 and 12 months

• Berg Balance Scale

  Change from baseline at 3, 6 and 12 months

• Four Stage Balance Test

  Change from baseline at 3, 6 and 12 months

• Walking speed

  Change from baseline at 3, 6 and 12 months

Study Arms (2)

Fall prevention intervention program conducted through telehealth

EXPERIMENTAL

The training program is based on the principles of the Otago program, designed specifically to prevent falls. It consists set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The training will be delivered to a group of 10 participants. Each participant will practice from home, using a zoom system. The duration of each training will be one hour, the frequency of training will be twice a week for three months.

Other: Fall prevention program training based on Otago principles

Similar fall prevention intervention program conducted through face to face group training

ACTIVE COMPARATOR

The training program is based on the principles of the Otago program, designed specifically to prevent falls. It consists set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The training will be delivered to a group of 10 participants. The training sessions will be delivered at the local community center, twice a week for one hour for three months.

Other: Fall prevention program training based on Otago principles

Interventions

Fall prevention program training based on Otago principles OTHER

balance and strength exercises

Fall prevention intervention program conducted through telehealth; Similar fall prevention intervention program conducted through face to face group training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• home-dwelling elderly, aged 65 years or more
• Identified to be at low to moderate risk of falling
• Risk of falling will be assessed according to a combination of subjective and objective evaluation. Subjective questions from the STEADI (stopping elderly accidents death, and injuries), an algorithm for fall risk screening, assessment, and intervention, developed by the American Center for Disease Control and Prevention, relate to (1) Feels unsteady when standing/walking, (2) Worries about falling, and (3) Has fallen no more than 3 times in the past year.

You may not qualify if:

• Subjects suffering from severe musculoskeletal pain or disorders that will limit completion of the assessment procedure such as pain limiting weight-bearing for no longer than a few minutes
• Unstable cardiovascular/pulmonary disease
• Unbalanced diabetes
• Neurological diseases such as stroke, Parkinson's, or multiple sclerosis
• Use of a walking aid (except for a cane)
• visual or hearing impairment that will not allow the use of technology for remote practice
• A score lower than 21/30 on the Montreal Cognitive Assessment score (MoCA),
• High risk of falling on the balance test (Mini-BESTest ≤ 20)

Sponsors & Collaborators

• University of Haifa: lead
• Western Galilee Hospital-Nahariya: collaborator

Study Sites (2)

The Faculty of Social Welfare and Health Science, Haifa University

Haifa, Israel

Location

Gold club Kfar vradim

Kfar Vradim, 2017000, Israel

Location

Related Publications (4)

• Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.

  PMID: 30703272 BACKGROUND

• Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.

  PMID: 24339273 BACKGROUND

• Bernocchi P, Giordano A, Pintavalle G, Galli T, Ballini Spoglia E, Baratti D, Scalvini S. Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):340-346. doi: 10.1016/j.jamda.2018.09.003. Epub 2018 Oct 23.

  PMID: 30366759 BACKGROUND

• Toledano-Shubi A, Livne D, Hel-Or H, Bahat HS. Remote fall prevention training for community-dwelling older adults: comparison with face-to-face and effect of delivery sequence-A randomized controlled trial. Geriatr Nurs. 2026 Jan 21;69:103817. doi: 10.1016/j.gerinurse.2026.103817. Online ahead of print.

  PMID: 41570620 DERIVED

Related Links

• Centers for Disease Control and Prevention. STEADI- Older adult fall prevention
• Otago Exercise Programme to prevent falls in older adults

Study Officials

• Hilla Sarig Bahat, PT PhD

  Department of Physical Therapy, University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Functional and balance tests will be performed by a skilled physiotherapist, blind to the participant's group affiliation
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention program will include Otago- based fall prevention training face-to-face or remote. Each subject will receive the two types of interventions in sequence, with a cooling-off period between them. The intervention program in this study will last 6 months, however, the intervention arm will be swapped after 3 months.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 24, 2021
• Study Start: November 28, 2021
• Primary Completion: March 26, 2023
• Study Completion: March 26, 2023
• Last Updated: November 13, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)