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

NCT06936865 | Completed DMC

• 2 other identifiers: GAIT2CARE-2023CEIm approval code 2023-071
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Multicomponent Exercise; Digital Health; Home-based Intervention; Older Adults; Physical Performance; VIVIFIL App; Fall Prevention; Remote Monitoring; Geriatric Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Change in 4-Meter Gait Speed

  Baseline and 8 weeks

Other Outcomes (3)

• Change in Timed Up and Go (TUG) Test

  Baseline and 8 weeks

• Change in Frailty Status (Standardised Frailty Criteria)

  Baseline and 8 weeks

• Number of Falls During the Intervention Period

  8 weeks

Study Arms (2)

Home-based Exercise with Digital Support (ViviFil App)

EXPERIMENTAL

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

In-person Supervised Exercise at Geriatric Day Hospital

ACTIVE COMPARATOR

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

Interventions

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.

Home-based Exercise with Digital Support (ViviFil App)

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.

In-person Supervised Exercise at Geriatric Day Hospital

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Terminal illness with a life expectancy of less than 6 months
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Spanish National Research Council: lead
• Hospital Universitario Infanta Leonor: collaborator
• Servicio de Salud de Castilla La Mancha, Albacete, Spain: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Hospital Universitario Infanta Leonor - HUIL

Madrid, Madrid, 28031, Spain

Location

MeSH Terms

Conditions

Frailty; Mobility Limitation; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was implemented. All participants and study personnel were aware of group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Scientist

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 20, 2025
• Study Start: July 27, 2023
• Primary Completion: May 27, 2024
• Study Completion: February 28, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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.
• Access Criteria: 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.

Locations

ES (1)