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NCT Number: NCT03750500

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

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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Key information

Conditions

Fall

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USF Aldoar

Porto, Portugal

Location contact

Mariana Sant'Ana

CONTACT

+351918448194

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Illiteracy

Treatment and study plan

Biofeedback device

Device

12-week exercise program performed through the device

Other names: SWORD Phoenix

Education on falls risk

Behavioral

Education on falls risk factors and how to minimize them

Medication review

Other

Medication will be reviewed to reduce sedative drugs and minimize interactions

Visual and auditory screening

Diagnostic Test

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

Primary outcomes

  1. 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

  1. Change in the Timed Up and Go Test score

    Time frame: Baseline; week 4; week 8; week 12 and then week 24

    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.

  2. Change in the Berg Balance Scale

    Time frame: Baseline; week 4; week 8; week 12 and then week 24

    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.

  3. Change in the Shorts Falls Efficacy Scale-International

    Time frame: Baseline; week 4; week 8; week 12 and then week 24

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Correia, MD

CONTACT

[email protected]

+351966557789

Mariana Sant'Ana, MD

CONTACT

[email protected]

+351918448914

Sponsors and collaborators

Lead sponsor

Sword Health, SA

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 23, 2018
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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