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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
81
balance and strength exercises
The Faculty of Social Welfare and Health Science, Haifa University
Haifa, Israel
Gold club Kfar vradim
Kfar Vradim, Israel
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.
Time frame: Falls will be monitored for one year
Mini Balance Evaluation Systems Tests
Mini Balance Evaluation Systems Tests (Mini-BESTest) is a clinical balance assessment tool. This test includes 14 items, each scored from 0 (severe balance impairment) to 2 (no balance impairment). The maximal possible score is 28 points. Higher scores indicate better balance performance. A score of 20 points or below indicates a high fall risk.
Time frame: Change from baseline at 3, 6 and 12 months
Time-Up and Go Test
The Timed Up and Go Test (TUG) assesses mobility, balance, and fall risk in older adults. The test measures the time required for a subject to stand up from sitting on a chair, walk for 3 meters, turn, walk back, and sit down. A score of 12 seconds or more indicates risk of falling in community dwelling adults.
Time frame: Change from baseline at 3, 6 and 12 months
Berg Balance Scale
The Berg Balance Scale (BBS) is a 14- item objective measure that assesses static and dynamic balance, and fall risk in adults. Each item is scored from 0 (unable to perform) to 4 (normal performance). The maximal possible score is 56 points. Any score from 0 to 36 indicate 100% fall risk for older adults. The Berg Balance Scale (BBS) is widely used in clinical practice to predict falls in the older adults. lately, due to ceiling effect, the use of BBS as a single measure to accurately predict future falls seems to be insufficient.
Time frame: Change from baseline at 3, 6 and 12 months
Four Stage Balance Test
The 4-Stage Balance Test assess static balance at four standing positions, that get progressively harder to maintain. The person is asked to hold a position for 10 seconds without moving his feet or supporting. An older adult, who cannot hold the tandem stand, which is the forth position, for at least 10 seconds, is at increased risk of falling.
Time frame: Change from baseline at 3, 6 and 12 months
Walking speed
Walking speed will be measured using the 4-Meter Walk Test in seconds. Walking speed lower than 1.0 seconds/meter is considered a strong predictor of falls in the elderly population living in the community.
Time frame: Change from baseline at 3, 6 and 12 months
Lower extremities functional strength
Functional strength of the lower limbs will be measured by the 30-second Sit to Stand Test. This is also used for fall prediction. A result lower than expected by age and sex indicates a risk of falls
Time frame: Change from baseline at 3, 6 and 12 months
Attendance
Attendance to the program will be recorded each class by the physiotherapist who will conduct the training. Total attendance will be defined as the number/percentage of classes attended out of the total number of sessions conducted, for example attending 75 sessions out of 100 will be calculated as total attendance of 75%.
Time frame: Will be monitored and record in any session time, for 6 months
Completion (retention)
Completion of the full period of the program- 6 months, will be recorded for each participant, and will reflect retention. Non-completion will be recorded for the participants who will withdrawal from the program before the end of the program, and will not complete the 6 months, end of program, assessment.
Time frame: Will be monitored and record in any session time, for 6 months
Satisfaction from program
Participant satisfaction will be assessed using a satisfaction rating scale of 0-10, with a score of 0 indicating complete dissatisfaction and a score of 10 maximum satisfaction.
Time frame: Twice- after each program session (after 3 and 6 months).
Fear of falls
Fear of falls will be assessed using the Modified Falls Efficacy Scale (MFES) questionnaire, which is one of the most common and reliable research tools in fall research. In this questionnaire, the subject rates his confidence in performing 10 daily tasks
Time frame: Change from baseline at 3, 6 and 12 months
12-Item Short Form Survey (SF-12) Quality of life questionnaire
Quality of life will be assessed using the SF-12 questionnaire. This questionnaire assesses the perception of quality of life through 12 questions that relate to the subject's views about his state of health and ability to perform various actions and functions. The use of this questionnaire is common in fall studies.
Time frame: Change from baseline at 3, 6 and 12 months
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