Frail Elderly
Conditions
Keywords
exercise, frailty, elderly, physiotherapy, primary care
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFRAIL+AP Program
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.
OTHERUsual Care
Standard primary care management according to regional healthcare guidelines without structured exercise intervention.
Sponsors
Alberto Bermejo Franco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to treatment allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the FRAIL+AP intervention group or a usual-care control group. Both groups will be followed in parallel throughout the 12-week study period.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frailty status measured by the FRAIL Scale | Baseline and 12 weeks | 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) | Baseline and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Falls | Baseline and 12 weeks | Number of falls recorded during the study period using participant diaries and verified through electronic medical records. |
| Musculoskeletal Pain Intensity | Baseline and 12 weeks | 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 | Baseline and 12 weeks | 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 | Baseline and 12 weeks | 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. |
| Nutritional Status | Baseline and 12 weeks | 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. |
| Handgrip Strength | Baseline and 12 weeks | Change in upper-limb muscle strength measured by handgrip dynamometry. The highest value obtained from standardized testing procedures will be recorded. |
| Comorbidity Burden | Baseline and 12 weeks | Change in clinical comorbidity status assessed using the Charlson Comorbidity Index. |
| Healthcare Resource Utilization | Baseline and 12 weeks | 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. |
Countries
Spain
Contacts
CONTACTÁngel Moisés Reyes Abreu, Registered Nurse
CONTACTAlberto Bermejo Franco, PhD (Physiotherapy)
PRINCIPAL_INVESTIGATORÁngel Moisés Reyes Abreu, Registered Nurse
Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife
STUDY_DIRECTORAlberto Bermejo Franco, PhD (Physiotherapy)
Universidad Europea de Madrid. Adress: C/ Tajo, S/N. 28670 Villaviciosa de Odón (Madrid)
Outcome results
None listed