An interventional study of VIVIFIL App Program and Hospital-Based Multicomponent Exercise in Falls, Frailty Syndrome and Gait Disorders, sponsored by Spanish National Research Council. Completed at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Spanish National Research Council · Not applicable, Interventional, and Prevention
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.
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This study's enrollment of 127 is above the median of 80 across 681 interventional studies indexed under Frailty.
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At least one of the following:
Exclusion Criteria:
Participants in this arm followed a personalized multicomponent exercise program at home using the VIVIFIL mobile application. The program included strength, balance, flexibility, and aerobic exercises adapted to each participant's functional capacity (based on SPPB score). The VIVIFIL App was installed on participants' smartphones or provided devices and included daily video-guided sessions, automatic progression, and a chat function for communication with healthcare professionals who provided remote monitoring.
Behavioral: VIVIFIL App Program
Participants in this arm attended supervised multicomponent exercise sessions at the Geriatric Day Hospital, 2-4 times per week for 8 weeks. Each session lasted 45-60 minutes and was delivered by trained professionals. Exercises included strength training, balance exercises, flexibility, and aerobic conditioning. Programs were tailored based on the participant's initial functional assessment.
Behavioral: Hospital-Based Multicomponent Exercise
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.
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.
Change in Short Physical Performance Battery (SPPB) Score
The SPPB is a standardized assessment tool that includes gait speed, chair stand, and balance tests. Scores range from 0 to 12, with higher scores indicating better physical performance. The primary outcome is the change in total SPPB score from baseline to 8 weeks.
Time frame: Baseline and 8 weeks
Change in 4-Meter Gait Speed
Gait speed (m/s) is measured over a 4-meter walk. The best of three trials is recorded. Higher speed reflects better functional capacity.
Time frame: Baseline and 8 weeks
Change in Timed Up and Go (TUG) Test
The TUG test assesses functional mobility. Participants are timed as they rise from a chair, walk 3 meters, turn, return, and sit. A lower time indicates better performance.
Time frame: Baseline and 8 weeks
Change in Frailty Status (Standardised Frailty Criteria)
Frailty status is assessed using criteria including weight loss, grip strength, exhaustion, slow gait, and low activity. Participants are classified as robust, pre-frail, or frail.
Time frame: Baseline and 8 weeks
Number of Falls During the Intervention Period
Total number of falls reported by participants during the 8-week intervention period. Falls were self-reported and monitored by the research team.
Time frame: 8 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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Spanish National Research Council