FreeFrail Project: Effectiveness of a Multicomponent Intervention Including Dual-task Exercise to Increase Functionality and Cognitive Performance in Frail and Pre-frail Individuals Over 65 Years Aged in Primary Care Compared to Usual Care: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Physical performance and functional status
研究概览
简要总结
The primary aim is to assess the effectiveness of a multicomponent intervention including dual-task exercise in improving functionality and cognitive performance and in reducing frailty among community-dwelling adults aged ≥65 years compared to usual care. Secondary objectives include evaluating its impact on pain, anxiety or depression, sleep quality, quality of life, physical activity, handgrip strength, and polypharmacy.
A double-blind, randomized, parallel-group controlled trial will be conducted in primary care centers in Lleida. Frail older adults (≥65 years) will be recruited and randomly allocated to either the intervention group, receiving a structured cognitive-motor dual-task based multicomponent program, or the control group, receiving usual care. Outcomes will be assessed using validated tools at baseline and follow-up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 or older
- •Frailty according to Fragil-VIG index (>0,20)
- •Barthel index > 60
- •Able to perform physical exercise
- •Able to understand and communicate in Catalan or Spanish
排除标准
- •Decompensated / Unstable cardiovascular disease or recent diagnosed
- •Upper or lower injury with functional impairment
- •Institutionalized patient.
- •Terminal or tumoral processes
- •People who participated in another clinical trial or exercise programme during last year
- •Diagnosis of severe dementia
结局指标
主要结局
Physical performance and functional status
时间窗: From enrollment to the end of treatment at 12 weeks
The Short Physical Performance Battery (SPPB) is an ordinal quantitative scale ranging from 0 to 12. This validated tool assesses three functional domains: lower-limb muscle strength, by timing the repeated chair-stand test; gait speed, through the 4-meter walking test; and static balance, evaluated with three progressively difficult positions (feet together, semi-tandem, tandem). A composite score is calculated, with lower values reflecting poorer performance. A score of 9 or less has been widely adopted as a cut-off point for identifying frailty and pre-frailty in older adults, making this instrument particularly suitable for evaluating the effectiveness of interventions on physical function
Cognitive function
时间窗: From enrollment to the end of treatment at 12 weeks
The Mini-Mental State Examination (MMSE) is a continuous quantitative widely used 30-point screening tool validated for older adults to assess global cognitive function. It evaluates orientation, memory, attention, language, and praxis, providing a standardized quantitative measure of cognitive status. Although limited in sensitivity for mild or executive deficits, the MMSE remains a practical first-line assessment in frailty research and clinical protocols, and its integration alongside multidimensional frailty measures allows for a more comprehensive characterization of cognitive vulnerability in aging. A culturally adapted and validated version is available in Spanish, enabling its use in Hispanic populations.
Frailty status
时间窗: From enrollment to the end of treatment at 12 weeks
The Frailty-VIG is an ordinal quantitative measure specifically validated for older adults in the community. This multidimensional tool comprises 22 dichotomous items spanning activities of daily living, nutrition, cognition, emotional health, social context, geriatric syndromes, and chronic diseases. By incorporating multimorbidity and psychosocial domains alongside physical aspects, the Frailty-VIG provides a comprehensive assessment of frailty, overcoming the limitations of purely physical indices
次要结局
- Quality of life / Anxiety and Depression / Pain severity(From enrollment to the end of treatment at 12 weeks)
- Sleep performance(From enrollment to the end of treatment at 12 weeks)
- Physical activity(From enrollment to the end of treatment at 12 weeks)
- Handgrip strength(From enrollment to the end of treatment at 12 weeks)
- Inflammatory and mitochondrial function biomarkers(From enrollment to the end of treatment at 12 weeks)
研究者
Oriol Martínez Navarro
Doctor
Universitat de Lleida