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

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03750500
• Other study ID #: SH-RCT-FP-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2022
• Source: Sword Health, SA
• Contact: Fernando Correia, MD
• Phone: +351966557789
• Email: fanacorreia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged over 65 years old

2. Ability to walk at least 20 meters, unaided or with unilateral support

3. Ability to understand motor complex commands

4. Mini-Mental State Examination (MMSE) score > 24 points

5. Functional independence for instrumental activities of daily living

6. Risk of recurrent falls, defined as 5xSST score > 15,00 seconds

Exclusion Criteria:

1. Patients residing in nursing homes, daycare units or assisted-living facilities

2. Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program

3. Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program

4. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity

5. Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program

6. Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)

7. Other medical complications, which prevent the patient from complying with a home-based exercise program

8. Illiteracy

Related Conditions & MeSH terms

• Fall

Intervention

Device:
• Biofeedback device
12-week exercise program performed through the device

Behavioral:
• Education on falls risk
Education on falls risk factors and how to minimize them

Other:
• Medication review
Medication will be reviewed to reduce sedative drugs and minimize interactions

Diagnostic Test:
• Visual and auditory screening
Patients will go through visual and auditory screening as part of their regular care

Locations

Country	Name	City	State
Portugal	USF Aldoar	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Sword Health, SA

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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