Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) for Frail Older Adults in Primary Care

Official title

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

Overview

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

• Behavioral FRAIL+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.
• Other Usual Care
  Standard primary care management according to regional healthcare guidelines without structured exercise intervention.

Primary outcome measures

• Change in frailty status measured by the FRAIL Scale [Time frame: Baseline and 12 weeks]
• Change in physical performance measured by the Short Physical Performance Battery (SPPB) [Time frame: Baseline and 12 weeks]

Secondary outcome measures (8)

• Incidence of Falls [Time frame: Baseline and 12 weeks]
• Musculoskeletal Pain Intensity [Time frame: Baseline and 12 weeks]
• Mood and Affective Status [Time frame: Baseline and 12 weeks]
• Functional Independence [Time frame: Baseline and 12 weeks]
• Nutritional Status [Time frame: Baseline and 12 weeks]
• Handgrip Strength [Time frame: Baseline and 12 weeks]
• Comorbidity Burden [Time frame: Baseline and 12 weeks]
• Healthcare Resource Utilization [Time frame: Baseline and 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Centro de Salud Tacoronte — Tacoronte

Publications

• Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923. PMID 21205966
• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85. PMID 8126356
• Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3. PMID 9990575
• Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4. PMID 7183759
• Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2. PMID 22836700
• Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x. PMID 41120990
• Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters PMID 34409961
• Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4. PMID 31609229

Identifiers

NCT: NCT07643064 · CHUC_2026_19 · PIFIISC 25/28

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗