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

ConditionFrail Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversidad Europea de Madrid

About this trial

Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited.

This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system.

The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.

Eligibility criteria

Qualifiers

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.

Functional independence sufficient to participate in the intervention (Barthel Index >80.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • FRAIL+AP Program
  • Usual Care

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universidad Europea de Madrid

Lead sponsor

Fundación Canaria Instituto de Investigación Sanitaria de Canarias

Sponsor institution