Can a 6-Month class turn back frailty? a trial tests In-Person, online, and hybrid learning
NCT ID NCT07738393
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial tests whether a 6-month healthy-aging education program—offered in person, online, or in a hybrid format—can reduce frailty in adults aged 65 and older who are pre-frail or frail. Participants are randomly assigned to one of the three education formats or to usual care. The program covers physical activity, nutrition, mental and emotional well-being, and social connection. Researchers will measure changes in frailty at 6 and 12 months, and also look at costs, quality of life, and biological markers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A 6-month healthy-aging education program delivered in person, online, or in a hybrid format, covering physical activity, nutrition, cognitive and emotional well-being, and social connection.
- What this could lead to
- If effective, this program could offer a practical, low-cost way to help older adults with frailty maintain independence and improve quality of life, potentially reducing healthcare costs.
- What could go wrong
- The trial is relatively small and the program's success may depend on delivery format and participant engagement. Results may not apply to all older adults, and the educational content's long-term impact remains uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 276 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Community-dwelling adults aged 65 years or older. * Presence of pre-frailty or frailty according to the prespecified operationalization of the Fried frailty phenotype, defined as meeting at least one of the five Fried criteria (pre-frailty: 1-2 criteria; frailty: 3-5 criteria). * Ability to understand spoken and written Spanish sufficiently to follow the intervention and study procedures. * Access at home to Wi-Fi or mobile data and to a smartphone, tablet, or computer capable of connecting to the internet. * Ability to attend the study assessments and, if randomized to the in-person or hybrid intervention, the scheduled face-to-face sessions. * Ability to understand the study information and provide written informed consent. Exclusion Criteria: * Permanent residence in a nursing home or other long-term residential care institution. * Robust status according to the Fried frailty phenotype, defined as meeting none of the five Fried criteria. * Severe dementia or any cognitive, neurological, or psychiatric condition that precludes valid informed consent or the ability to understand and follow the study procedures. * Use of systemic antibiotics during the 3 months preceding baseline stool-sample collection. * Known terminal illness or receipt of end-of-life care, with an anticipated life expectancy of less than 12 months, based on available clinical documentation or assessment by a qualified clinician. * Current participation in another interventional study involving an investigational medicinal product or a structured physical activity, nutritional, cognitive, or social intervention that overlaps with the FRAGSALUD-ON intervention or follow-up period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universidad de Cádiz
Puerto Real, Cádiz, 11519, Spain
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