Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People

NCT03750500 | Not Yet Recruiting

• 1 other identifier: SH-RCT-FP-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in the Timed Up and Go Test score

  Baseline; week 4; week 8; week 12 and then week 24

• Change in the Berg Balance Scale

  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

Study Arms (2)

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

Device: Biofeedback device; Behavioral: Education on falls risk; Other: Medication review; Diagnostic Test: Visual and auditory screening

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.

Behavioral: Education on falls risk; Other: Medication review; Diagnostic Test: Visual and auditory screening

Interventions

Biofeedback device DEVICE

12-week exercise program performed through the device

Also known as: SWORD Phoenix

Experimental

Education on falls risk BEHAVIORAL

Education on falls risk factors and how to minimize them

Experimental; Standard of Care

Medication review OTHER

Medication will be reviewed to reduce sedative drugs and minimize interactions

Experimental; Standard of Care

Visual and auditory screening DIAGNOSTIC_TEST

Patients will go through visual and auditory screening as part of their regular care

Experimental; Standard of Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Illiteracy

Sponsors & Collaborators

• Sword Health, SA: lead

Study Sites (1)

USF Aldoar

Porto, Portugal

Location

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Central Study Contacts

Fernando Correia, MD

CONTACT

+351966557789; fanacorreia@gmail.com

Mariana Sant'Ana, MD

CONTACT

+351918448914; mariana.magsant@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available upon study publication, for 5 years.
• Access Criteria: The protocol will be made available through this platform.

Locations

PT (1)