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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants included in this arm will benefit from a 12-week exercise program using the novel biofeedback rehabilitation device, under remote monitoring from a physical therapist |
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| Standard of Care | Placebo Comparator | Patients included in this arm will benefit from the standard of care currently in place in the Primary Care facility: education on risk factors for falls, medication review, visual and auditory acuity screening. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback device | Device | 12-week exercise program performed through the device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline; week 4; week 8; week 12 and then week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; week 4; week 8; week 12 and then week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Correia, MD | Contact | +351966557789 | fanacorreia@gmail.com | |
| Mariana Sant'Ana, MD | Contact | +351918448914 | mariana.magsant@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Aldoar | Porto | Portugal |
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Study protocol and study aggregate results (including anonymised individual patient data) will be made available
The data will become available upon study publication, for 5 years.
The protocol will be made available through this platform.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 14, 2018 | Nov 20, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000090143 | Medication Review |
| ID | Term |
|---|---|
| D008509 | Medication Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010346 | Patient Care Management |
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| Education on falls risk | Behavioral | Education on falls risk factors and how to minimize them |
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| Medication review | Other | Medication will be reviewed to reduce sedative drugs and minimize interactions |
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| Visual and auditory screening | Diagnostic Test | Patients will go through visual and auditory screening as part of their regular care |
|
| 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. |
| 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). | Baseline; week 4; week 8; week 12 and then week 24 |