An interventional study of FRAIL+AP Program and Usual Care in Frail Elderly, sponsored by Alberto Bermejo Franco. Recruiting at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Alberto Bermejo Franco · Not applicable, Interventional, and Treatment
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →This is the only study on the registry with Alberto Bermejo Franco as lead sponsor.
Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Discontinuation Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 12-week intervention consisting of a Comprehensive Geriatric Assessment (CGA), health education, and a multicomponent exercise program combining strength, balance, mobility, flexibility, and visual-spatial gait retraining using the Tapiz Fisior system. The intervention includes one supervised session and one home-based session per week.
Behavioral: FRAIL+AP Program
Participants receive standard primary care follow-up according to the Canary Health Service guidelines, including routine medical care and general lifestyle recommendations, without participation in the FRAIL+AP structured exercise program.
Other: Usual Care
A 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.
Standard 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).
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
Incidence of Falls
Number of falls recorded during the study period using participant diaries and verified through electronic medical records.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
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.
Time frame: Baseline and 12 weeks
Nutritional Status
Change in nutritional status measured using the Mini Nutritional Assessment (MNA). The MNA total score ranges from 0 to 30, with higher scores indicating better nutritional status. Scores \<17 indicate malnutrition, 17-23.5 indicate risk of malnutrition, and 24-30 indicate normal nutritional status.
Time frame: Baseline and 12 weeks
Handgrip Strength
Change in upper-limb muscle strength measured by handgrip dynamometry. The highest value obtained from standardized testing procedures will be recorded.
Time frame: Baseline and 12 weeks
Comorbidity Burden
Change in clinical comorbidity status assessed using the Charlson Comorbidity Index.
Time frame: Baseline and 12 weeks
Healthcare Resource Utilization
Healthcare utilization assessed through review of electronic medical records, including primary care visits, emergency department attendance, hospital admissions, and other healthcare contacts during the study period.
Time frame: Baseline and 12 weeks
Plan to share: Undecided — Data sharing plans have not yet been finalized. Any future sharing of de-identified individual participant data will be considered in accordance with ethical, legal, and institutional requirements.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 7 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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