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

NCT ID: NCT06936865

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2025-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Home-based Exercise with Digital Support (ViviFil App)

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.

Group Type: EXPERIMENTAL

VIVIFIL App Program

Intervention Type: 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.

In-person Supervised Exercise at Geriatric Day Hospital

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.

Group Type: ACTIVE_COMPARATOR

Hospital-Based Multicomponent Exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Infanta Leonor

OTHER

Sponsor Role: collaborator

Servicio de Salud de Castilla La Mancha, Albacete, Spain

UNKNOWN

Sponsor Role: collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Spanish National Research Council

OTHER_GOV

Sponsor Role: lead

Responsible Party

Antonio R. Jiménez Ruiz

Tenured Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Infanta Leonor - HUIL

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

CEIm approval code 2023-071

Identifier Type: OTHER

Identifier Source: secondary_id

GAIT2CARE-2023

Identifier Type: -

Identifier Source: org_study_id