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Completed

NCT Number: NCT06936865

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

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.

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Key information

Conditions

Falls Aging Behavior Frailty Frailty Syndrome Gait Disorders Mobility Limitation Pathologic Processes Pathological Conditions, Signs and Symptoms Sedentary Behavior Sedentary Behaviors Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Infanta Leonor - HUIL

Madrid, 28031, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • A fall with consequences requiring medical attention in the past year
  • Two or more falls in the past 12 months
  • Self-reported gait or balance disturbance
  • 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

Treatment and study plan

VIVIFIL App Program

Behavioral

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.

Hospital-Based Multicomponent Exercise

Behavioral

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.

Primary outcomes

  1. Change in Short Physical Performance Battery (SPPB) Score

    Time frame: 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 outcomes

  1. Change in 4-Meter Gait Speed

    Time frame: 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 outcomes

  1. Change in Timed Up and Go (TUG) Test

    Time frame: 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.

  2. Change in Frailty Status (Standardised Frailty Criteria)

    Time frame: 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.

  3. Number of Falls During the Intervention Period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spanish National Research Council

Other Gov

Collaborators

  • Hospital Universitario Infanta Leonor
  • Servicio de Salud de Castilla La Mancha, Albacete, Spain
  • Universidad Rey Juan Carlos

Registry information

Official study 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)

Acronym: GAIT2CARE

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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