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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое Usual Care
  Standard primary care management according to regional healthcare guidelines without structured exercise intervention.

Первичные конечные точки

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

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Centro de Salud Tacoronte — Tacoronte

Публикации

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• 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

Идентификаторы

NCT: NCT07643064 · CHUC_2026_19 · PIFIISC 25/28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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