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

Frailty is a prevalent geriatric syndrome characterized by decreased physiological reserve and increased vulnerability to adverse health outcomes, including falls, disability, hospitalization, institutionalization, and mortality. The Canary Islands have one of the highest rates of frailty and pre-frailty among community-dwelling older adults in Spain, highlighting the need for effective and scalable interventions within primary care settings.

Comprehensive Geriatric Assessment (CGA) is considered the gold standard for identifying multidimensional health needs in older adults and for guiding individualized care plans. In parallel, multicomponent exercise programs incorporating strength, balance, endurance, and flexibility training have demonstrated effectiveness in improving physical function and reducing frailty-related impairments. However, challenges remain regarding the implementation of these interventions in routine primary care practice.

The FRAIL+AP study is a multicenter, randomized controlled trial designed to evaluate the clinical efficacy of a primary care-based intervention combining Comprehensive Geriatric Assessment, health education, and a supervised multicomponent exercise program in frail and pre-frail older adults. The intervention also incorporates visual-spatial gait retraining using the Tapiz Fisior system, a structured floor-grid tool aimed at improving gait control, balance, coordination, and fall prevention.

A total of 200 community-dwelling adults aged 70 years and older will be recruited from five primary care centers in Tenerife, Spain. Eligible participants will be randomly allocated in a 1:1 ratio to either the intervention group or a control group receiving usual care. The intervention will last 12 weeks and will consist of supervised and home-based exercise sessions, together with educational activities focused on healthy lifestyles, nutrition, frailty awareness, and fall prevention.

Primary outcomes include changes in frailty status assessed by the FRAIL Scale and physical performance measured using the Short Physical Performance Battery (SPPB). Secondary outcomes include incidence of falls, pain perception, mood, functional independence, nutritional status, handgrip strength, healthcare resource utilization, and comorbidity measures. Outcomes will be assessed at baseline and one week after completion of the intervention by blinded evaluators.

The study aims to determine whether the FRAIL+AP protocol can improve physical performance, reduce frailty, and support healthy aging through an integrated and scalable model that can be implemented within routine primary care services.

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.