CompletedNot Applicable

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

Spain127 participantsStarted 2023-07-27

Plain-language 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.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Short Physical Performance Battery (SPPB) Score

Timeframe: Baseline and 8 weeks

Trial details

NCT IDNCT06936865

SponsorSpanish National Research Council

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-05-27

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