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.

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.

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

Individual participant data (IPD) underlying published results will be made available after study completion and publication. The data will be fully anonymized and shared upon reasonable request with qualified researchers for academic and non-commercial purposes. Requests must include a methodologically sound proposal and may require approval by an independent ethics committee. Data access will be provided through a secure platform or encrypted file transfer.

Individual participant data (IPD) and supporting information will be available beginning 6 months after publication of the primary results and will remain accessible for a period of 5 years.

Qualified researchers affiliated with academic or clinical institutions may request access to anonymized individual participant data (IPD) and supporting documents. Requests must include a scientifically sound research proposal and may require approval by an ethics committee. Data will be shared via secure electronic transfer after signing a data access agreement that ensures confidentiality and appropriate data use.

No masking was implemented. All participants and study personnel were aware of group assignments.