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.
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.
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.
Parallel
FRAIL+AP Program
BehavioralA 12-week multicomponent intervention including Comprehensive Geriatric Assessment, health education, strength training, balance exercises, mobility training, flexibility exercises, and visual-spatial gait retraining using the Tapiz Fisior system. Participants attend one supervised session and perform one home-based session per week.
Usual Care
Other interventionStandard primary care management according to regional healthcare guidelines without structured exercise intervention.
Change in frailty status measured by the FRAIL Scale
Change in FRAIL Scale score from baseline to 12 weeks. The FRAIL Scale ranges from 0 to 5, with higher scores indicating greater frailty (0 = robust, 1-2 = pre-frail, 3-5 = frail).
Change in physical performance measured by the Short Physical Performance Battery (SPPB)
Change in the total Short Physical Performance Battery (SPPB) score from baseline to 12 weeks. The SPPB total score ranges from 0 to 12, with higher scores indicating better physical performance.
Incidence of Falls
Number of falls recorded during the study period using participant diaries and verified through electronic medical records.
Musculoskeletal Pain Intensity
Change in musculoskeletal pain intensity measured using the Numeric Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Mood and Affective Status
Change in depressive symptoms measured using the 15-item Geriatric Depression Scale (GDS-15). The GDS-15 total score ranges from 0 to 15, with higher scores indicating greater depressive symptomatology.
Functional Independence
Change in functional independence measured using the Barthel Index. The Barthel Index total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
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Alberto Bermejo Franco
Lead sponsor
Universidad Europea de Madrid
Sponsor institution
