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

NCT06936865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-04-20

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Hospital Universitario Infanta Leonor

    collaborator OTHER
  • Servicio de Salud de Castilla La Mancha, Albacete, Spain

    collaborator UNKNOWN
  • Universidad Rey Juan Carlos

    collaborator OTHER
  • Spanish National Research Council

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-27
Primary Completion
2024-05-27
Completion
2025-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06936865 on ClinicalTrials.gov