Clinical trial Recruiting at 1 site Interventional Ages 70 and up

Frailty in Older Adults: A Primary Care Program with Exercise and Geriatric Assessment

Official title: Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial

Run by Universidad Europea de Madrid · NCT07643064 · Data updated 2026-11-12

This trial tests a primary-care program that combines a full geriatric assessment with a 12-week multicomponent exercise plan to see if it improves frailty, functional ability, and reduces falls in frail or pre-frail adults aged 70 and older in the Canary Islands.

Quick facts

Study typeInterventional
Ages70 Years and up
SexAll
Enrollment200 (estimated)
SponsorUniversidad Europea de Madrid
Academic / other
Locations1 site (Tacoronte, Santa Cruz de Tenerife)
StatusRecruiting
StartedMay 28, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 7, 2026
Trial IDNCT07643064 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are community-dwelling adults aged 70+ with frailty or pre-frailty, able to consent, and cleared for low-to-moderate intensity exercise.

Probably not a fit

Frailty may not improve in individuals with severe frailty, cognitive impairment preventing participation, or medical conditions contraindicating exercise.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized trial will compare the FRAIL+AP program to usual care for community-dwelling adults aged 70+ who are frail or pre-frail. The program blends Comprehensive Geriatric Assessment, health education, and supervised multicomponent exercise (strength, balance, endurance, flexibility) with visual-spatial gait retraining using the Tapiz Fisior system. Outcomes include frailty status, physical performance, functional independence, and fall incidence over the study period. The study aims to determine whether integrating CGA with structured exercise in primary care can be scaled to reduce frailty-related adverse outcomes. Enrollment targets 200 participants across collaborating primary care centers in Tenerife.

Why it matters

Potential benefit: If successful, the program could improve mobility, independence, and reduce falls for frail older adults in primary care settings.

How similar studies have gone: Previous multicomponent exercise programs have shown benefits in similar populations, though integration with CGA in primary care remains an area of active investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Community-dwelling adults aged 70 years or older.
* Ability and willingness to provide written informed consent.
* Medical clearance to participate in low-to-moderate intensity physical exercise.
* Presence of frailty or pre-frailty defined by meeting at least two of the following criteria:
* Functional independence sufficient to participate in the intervention (Barthel Index \>80.
* FRAIL Scale score ≥ 1.
* Short Physical Performance Battery (SPPB) score \< 10.
* Gait speed \< 0.8 m/s.
* Timed Up and Go (TUG) test \> 12 seconds.
* Registered at one of the participating primary care centers.

Exclusion Criteria:

* Absolute contraindications to physical exercise, including recent acute myocardial infarction, unstable angina, severe uncontrolled cardiovascular disease, or severe uncorrected aortic stenosis.
* Severe cognitive impairment preventing comprehension of study procedures or exercise instructions.
* Severe psychiatric disorders interfering with participation.
* Absence of a legally authorized representative when required.
* Severe uncontrolled behavioral disturbances.
* Any acute or chronic medical condition considered by the investigators to make participation unsafe.

Discontinuation Criteria:

* Failure to attend the initial mandatory health education workshop.
* Attendance at fewer than 6 of the 12 scheduled supervised exercise sessions.
* Development of an acute medical condition that results in a temporary or permanent contraindication to physical activity.
* Participant withdrawal of informed consent.

Where it's running

  • Centro de Salud Tacoronte
    Tacoronte, Santa Cruz de Tenerife, Spain
    Recruiting

Study contacts

  • Principal investigator: Ángel Moisés Reyes Abreu, Registered Nurse — Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife
  • Study coordinator: Ángel Moisés Reyes Abreu, Registered Nurse
  • Email: enf.enlacetacoronte@gmail.com
  • Phone: +34922474058

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.