Aging, Falls, Frailty Syndrome, Gait Disorders, Mobility Limitation, Sedentary Behaviors
Conditions
Keywords
Multicomponent Exercise, Digital Health, Home-based Intervention, Older Adults, Physical Performance, VIVIFIL App, Fall Prevention, Remote Monitoring, Geriatric Rehabilitation
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.
Interventions
BEHAVIORALVIVIFIL 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.
BEHAVIORALHospital-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.
Sponsors
Hospital Universitario Infanta Leonor
Servicio de Salud de Castilla La Mancha, Albacete, Spain
Universidad Rey Juan Carlos
Spanish National Research Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking was implemented. All participants and study personnel were aware of group assignments.
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.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score | Baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 4-Meter Gait Speed | Baseline and 8 weeks | Gait speed (m/s) is measured over a 4-meter walk. The best of three trials is recorded. Higher speed reflects better functional capacity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Timed Up and Go (TUG) Test | Baseline and 8 weeks | 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. |
| Change in Frailty Status (Standardised Frailty Criteria) | Baseline and 8 weeks | 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. |
| Number of Falls During the Intervention Period | 8 weeks | Total number of falls reported by participants during the 8-week intervention period. Falls were self-reported and monitored by the research team. |
Countries
Spain
Outcome results
None listed