Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in the 5 Times Sit to Stand Test
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged over 65 years old
- •Ability to walk at least 20 meters, unaided or with unilateral support
- •Ability to understand motor complex commands
- •Mini-Mental State Examination (MMSE) score > 24 points
- •Functional independence for instrumental activities of daily living
- •Risk of recurrent falls, defined as 5xSST score > 15,00 seconds
Exclusion Criteria
- •Patients residing in nursing homes, daycare units or assisted-living facilities
- •Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
- •Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
- •Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
- •Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
- •Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)
- •Other medical complications, which prevent the patient from complying with a home-based exercise program
Outcomes
Primary Outcomes
Change in the 5 Times Sit to Stand Test
Time Frame: Baseline; week 4; week 8; week 12 and then week 24
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
Secondary Outcomes
- Change in the Berg Balance Scale(Baseline; week 4; week 8; week 12 and then week 24)
- Change in the Timed Up and Go Test score(Baseline; week 4; week 8; week 12 and then week 24)
- Change in the Shorts Falls Efficacy Scale-International(Baseline; week 4; week 8; week 12 and then week 24)