Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in frailty status measured by the FRAIL Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to treatment allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •FRAIL Scale score ≥
- •Short Physical Performance Battery (SPPB) score <
- •Gait speed < 0.8 m/s.
- •Timed Up and Go (TUG) test > 12 seconds.
- •Registered at one of the participating primary care centers.
排除标准
- •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.
研究组 & 干预措施
Usual Care
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.
干预措施: Usual Care (Other)
FRAIL+AP Program
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.
干预措施: FRAIL+AP Program (Behavioral)
结局指标
主要结局
Change in frailty status measured by the FRAIL Scale
时间窗: 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)
时间窗: 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.
次要结局
- Musculoskeletal Pain Intensity(Baseline and 12 weeks)
- Mood and Affective Status(Baseline and 12 weeks)
- Functional Independence(Baseline and 12 weeks)
- Nutritional Status(Baseline and 12 weeks)
- Incidence of Falls(Baseline and 12 weeks)
- Handgrip Strength(Baseline and 12 weeks)
- Comorbidity Burden(Baseline and 12 weeks)
- Healthcare Resource Utilization(Baseline and 12 weeks)
研究者
Alberto Bermejo Franco
Principal Investigator
Universidad Europea de Madrid