NCT06936865

Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls

Effectiveness of a Home-Based Multicomponent Exercise Program With Digital Support in Community-Dwelling Older Adults With Falls: A Multicenter Quasiexperimental Trial (GAITCARE Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Spanish National Research Council · Other Government
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Falls
• Frailty Syndrome
• Gait Disorders
• Mobility Limitation
• Aging
• Sedentary Behaviors

Interventions

Type	Name	Description
BEHAVIORAL	VIVIFIL App Program	A digitally supported multicomponent exercise program delivered through the VIVIFIL mobile application. Participants followed a daily home-based routine including strength, balance, flexibility, and aerobic exercises, adapted to their functional reserve. The app provided video instructions, progression tracking, and a chat for remote communication with healthcare professionals.
BEHAVIORAL	Hospital-Based Multicomponent Exercise	A supervised multicomponent exercise program delivered at a geriatric day hospital by trained professionals. Sessions lasted 45-60 minutes, 2-4 times per week for 8 weeks. Exercises included strength training, balance, flexibility, and aerobic components, adjusted to the participant's functional status.

Timeline

• Start date: 2023-07-27
• Primary completion: 2024-05-27
• Completion: 2025-02-28
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: Spain