Clinical trial NCT05018455: The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face
Official title: The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face in Low-medium Risk Elderly- A Cross Over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Keywords: Telehealth, fall prevention, home dwelling elderly, Otago
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Western Galilee Hospital-Nahariya
First posted: 2021-08-24
Enrollment: 81
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: The aim of the proposed study is to investigate the effectiveness of a remote fall prevention training program. The proposed intervention program includes an Otago-based fall prevention training program to improve lower extremity strength, balance, and walking, directed by physical therapists, over 6 months. The remote group will train at home, using video communication software, while the face-to-face group will train at a local community center.

The proposed study will be designed as a randomized control trial (RCT) with a cross-over design. The population will include 106 home-dwelling elderly, aged 65 years or more, walking independently, that will be identified at low to moderate risk of fall. Candidates with unbalanced systemic disease or disorders, cognitive and physical Impairments that will prevent participation in the program, will not be included. A full description of the inclusion and exclusion criteria is provided below in the Eligibility section.

Participants will be randomized into two groups that will receive similar Otago-based fall prevention group training, either remotely or face-to-face.

The training sessions: The training starts with five minutes of gentle warm-up with the same five flexibility exercises, followed by structured lower limb muscles strengthening, balance exercises, and instruction for independent walking for up to 30 minutes at least twice a week. The training will be delivered to groups of ten participants. The duration of each session will be one hour, twice a week for three months. After three months of training, there will be a two weeks break, serving as a washout period, after which the groups will switch, for another three months. At the end of the intervention period (6.5 months), each participant will be trained by both remote and face-to-face programs. Assessments will be conducted at 4-time points: baseline, 3 months after completion of the first-ordered training, 6.5 months after completion of both trainings, and 12 months follow up.

The primary outcome measure is the number of falls during a year. secondary outcome measures include Objective measures as balance, Walking speed, lower extremities functional strength, adherence, and compliance to the training program. The subjective outcome measure will include participant Satisfaction from the program, Fear of falls, and Quality of life. More details regarding outcome measures are provided below in the outcome measure section.

Statistical analysis: The equivalence test will be used to examine if the remote fall prevention training is as good as the face-to-face. In order to check if there is a period-treatment effect on the objective outcome measures we will employ a mixed-model repeated-measures analysis of variance (ANOVA): 4-time points (baseline, 3 months, 6 months, 12 months follow up) X 2 interventions (remote vs. face-to-face), counting for the fact that subjects are nested in sequence. When interaction will be significant simple mean analysis will be used to reveal a significant source. Studentized Maximum Modulus (SMM) post-hoc adjustment method will be used to reveal significance between pairs of periods.

If this study will manage to show remote fall prevention is feasible, safe, and effective, it will promote a solution in one of the most serious health problems in the elderly, in one of the most challenging eras for the elderly, when remote healthcare is vital.

Eligibility criteria: Inclusion Criteria:

* 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.

An additional inclusion criterion is scoring 21 or more in the Mini-Best test (a balance test).

Exclusion Criteria:

* 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)

Comment: exclusion criteria will be based on self-report and completed at the initial baseline assessment

Primary outcomes:
measure: Number of falls during the study period
timeFrame: Falls will be monitored for one year
Secondary outcomes:
measure: Mini Balance Evaluation Systems Tests
timeFrame: Change from baseline at 3, 6 and 12 months
measure: Time-Up and Go Test
timeFrame: Change from baseline at 3, 6 and 12 months
measure: Berg Balance Scale
timeFrame: Change from baseline at 3, 6 and 12 months
measure: Four Stage Balance Test
timeFrame: Change from baseline at 3, 6 and 12 months
measure: Walking speed
timeFrame: Change from baseline at 3, 6 and 12 months
measure: Lower extremities functional strength
timeFrame: Change from baseline at 3, 6 and 12 months
measure: Attendance
timeFrame: Will be monitored and record in any session time, for 6 months
measure: Completion (retention)
timeFrame: Will be monitored and record in any session time, for 6 months
measure: Satisfaction from program
timeFrame: Twice- after each program session (after 3 and 6 months).
measure: Fear of falls
timeFrame: Change from baseline at 3, 6 and 12 months
measure: 12-Item Short Form Survey (SF-12) Quality of life questionnaire
timeFrame: Change from baseline at 3, 6 and 12 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: The Faculty of Social Welfare and Health Science, Haifa University
city: Kfar vradim
country: Israel
facility: Gold club Kfar vradim
Study officials:
affiliation: Department of Physical Therapy, University of Haifa
name: Hilla Sarig Bahat, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.