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

Fall Clinical Trial

Official title: The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face in Low-medium Risk Elderly- A Cross Over Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fall

• NCT number: NCT05018455
• Study type: Interventional
• Source: University of Haifa
• Status: Completed
• Phase: N/A
• Start date: November 28, 2021
• Completion date: March 26, 2023