This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care. The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility. The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
12-week exercise program performed through the device
Education on falls risk factors and how to minimize them
Medication will be reviewed to reduce sedative drugs and minimize interactions
Patients will go through visual and auditory screening as part of their regular care
USF Aldoar
Porto, Portugal
Change in the 5 Times Sit to Stand Test
The 5 Times Sit to Stand Test is a performance test that measures the strength and the lower limb mobility. It consists of the time it takes to stand up from a chair five consecutive times. A cutoff value of 15 seconds is used to distinguish between individuals with and without risk of recurrent falls
Time frame: Baseline; week 4; week 8; week 12 and then week 24
Change in the Timed Up and Go Test score
The TUG is a performance test that assesses the mobility, balance and gait in elderly individuals, consisting of the time it takes to stand up from a chair, walk 3 meters, turn around, come back and sit down again.
Time frame: Baseline; week 4; week 8; week 12 and then week 24
Change in the Berg Balance Scale
The Berg Balance Scale was developed to evaluate the static and dynamic balance in three domains: sitting, standing and changing posture. It is a scale composed of 14 items graded by an external observer on 5 levels (from 0 to 4). Scale scores range from 0 to 56, with higher scores representing a higher level of functionality.
Time frame: Baseline; week 4; week 8; week 12 and then week 24
Change in the Shorts Falls Efficacy Scale-International
The Shorts Falls Efficacy Scale-International was developed in order to systematize on a scale the fear of falling. It is a questionnaire of 7 items filled by the user, evaluating from 1 to 4 the fear of falling during the execution of a series of activities of daily living. It is a standardized and comparable measure over time, which provides an additional dimension in the characterization of participants. The cutoff levels are: low fear (7-8); moderate fear (9-13) and high fear (14-28).
Time frame: Baseline; week 4; week 8; week 12 and then week 24
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