Clinical trial NCT06936865: Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls
Official title: Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls: A Multicenter Quasiexperimental Trial (GAITCARE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Frailty Syndrome
Gait Disorders
Mobility Limitation
Aging
Sedentary Behaviors
Keywords: Multicomponent Exercise
Digital Health
Home-based Intervention
Older Adults
Physical Performance
VIVIFIL App
Fall Prevention
Remote Monitoring
Geriatric Rehabilitation
Lead sponsor: Spanish National Research Council
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Universitario Infanta Leonor
name: Servicio de Salud de Castilla La Mancha, Albacete, Spain
name: Universidad Rey Juan Carlos
First posted: 2025-04-20
Enrollment: 127
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study follows a parallel, non-randomized interventional model. Participants were assigned to one of two arms based on the hospital where they received care, following standard clinical practice. No crossover occurred between groups. Each arm received a multicomponent exercise intervention with similar structure and objectives, delivered either in-person or at home with digital support. The primary comparison focuses on functional outcomes and fall incidence between the two settings.
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of an 8-week multicomponent exercise program conducted at home with digital support through the VIVIFIL mobile application, compared to a traditional in-person hospital-based exercise program, in community-dwelling older adults with a history of falls. The GAIT2CARE study is a multicenter, non-randomized, quasiexperimental clinical trial conducted in three Spanish public hospitals.

Participants aged 70 years or older were assigned to one of two intervention groups depending on the hospital: (1) home-based exercise using the VIVIFIL App with remote monitoring by a healthcare professional, or (2) conventional in-person multicomponent exercise supervised at the hospital. Both interventions included aerobic, strength, balance, and flexibility training.

The study aims to assess improvements in physical performance (SPPB, TUG, gait speed), frailty status, and fall incidence. Baseline and post-intervention assessments were conducted over an 8-week period. The hypothesis is that the home-based digital program is as effective as in-person exercise in improving functional outcomes and preventing falls in older adults.

Detailed description: The GAIT2CARE study is a multicenter, non-randomized, quasiexperimental clinical trial designed to evaluate the effectiveness of a home-based, multicomponent exercise intervention supported by a mobile application (VIVIFIL App) compared to a conventional in-person hospital-based program in community-dwelling older adults with a history of falls.

The study was conducted in three public university hospitals in Spain: Hospital Universitario Infanta Leonor, Hospital Universitario de Getafe, and Hospital Universitario de Albacete. A total of 127 participants aged 70 years or older were recruited from specialized fall clinics between December 2023 and March 2024. Eligibility criteria included a history of falls, ability to walk independently or with one or two canes, and absence of terminal illness. Participants were assigned to either the intervention or control group based on their hospital site, as per standard clinical practice.

The intervention group used the VIVIFIL App, a tool specifically designed for older adults to guide daily exercise at home. The App includes tailored training programs based on functional reserve (measured by SPPB), progressive difficulty levels, and real-time communication with healthcare professionals. Participants who lacked smartphones were provided with one and received training on how to use the App.

The control group attended conventional multicomponent exercise sessions (45-60 minutes, 2-4 times per week) at a geriatric day hospital under professional supervision. Both programs included strength, aerobic, flexibility, and balance training.

Primary outcomes included changes in physical performance (SPPB, Timed Up and Go \[TUG\], 4-meter gait speed), frailty status, and incidence of falls. Assessments were conducted at baseline and after 8 weeks. The study also included an analysis of factors influencing response to the intervention, such as baseline frailty, cognitive status, and adherence.

Eligibility criteria: Inclusion Criteria:

* Age 70 years or older
* Attending a specialized falls clinic at one of the participating hospitals
* Able to ambulate independently or with the aid of one or two canes
* At least one of the following:

  1. A fall with consequences requiring medical attention in the past year
  2. Two or more falls in the past 12 months
  3. Self-reported gait or balance disturbance
  4. Self-reported fear of falling

Exclusion Criteria:

* Terminal illness with a life expectancy of less than 6 months
* Refusal or inability to provide informed consent

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) Score
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in 4-Meter Gait Speed
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Change in Timed Up and Go (TUG) Test
timeFrame: Baseline and 8 weeks
measure: Change in Frailty Status (Standardised Frailty Criteria)
timeFrame: Baseline and 8 weeks
measure: Number of Falls During the Intervention Period
timeFrame: 8 weeks
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor - HUIL
Study officials:
References: