NCT05435534Unknown不适用
Effect of a Multicomponent Intervention With Telerehabilitation and Vivifrail on Functional Capacity After Hip Fracture: a Randomized Control Trial
Fundacion Miguel Servet1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2022年5月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery (SPPB)
研究概览
简要总结
Due to the clinical, functional, cognitive and social complexity of older adults after fragility hip fractures (defined as those produced by low-impact trauma), the investigators propose an intervention.
This intervention involves a multidisciplinary and multicomponent program consisting of physical exercise with tele-rehabilitation, nutritional assessment and other variables related to comprehensive geriatric assessment.
The investigators want to improve functional status, quality of life and prevent new fractures. In addition, the investigators try to optimize treatments and resources based on the functional status of patients and their life expectancies, improving care and healthcare cost
详细描述
Study aims
- Improve functional capacity (Short Physical Performance Battery, SPPB) in older patients with fragility hip fractures through a multidisciplinary and multicomponent program and increase the quality of life (EuroQol-5 Dimension) and reduce the use of resources (admission and readmission to emergency department or in-hospital) at 3, 6 and 12 months compare with usual care
- Analyze the subgroups of patients that benefit the most from the respective interventions, identifying factors of the patient (sociodemographic, clinical, functional and cognitive) and of the intervention (type of exercise, nutritional supplementation, pain control, etc.), which could explain differences in the effectiveness of the intervention at 3, 6 and 12 months
- Analyze the effect of multidisciplinary and multicomponent intervention in older adults with hip fracture on cognitive capacity (4-AT, MMSE), risk of falls (number of falls, Falls Efficacy Scale), depression (GDS), pain (VAS), polypharmacy, geriatric syndromes and nutritional status (MNA) compare with usual care at 3, 6 and 12 months
- Developmentally monitor the changes achieved through the intervention, as well as the factors that determine the perpetuation of the benefits of the long-term.
- Examine the effect of a multi-component program on muscle mass (DXA), bone formation and resorption (BTMs) at 12 months
- Estimate the prevalence of frailty, multimorbidity and geriatric syndromes in older adults with fragility hip fracture and the changing at 3, 6 and 12 months.
- Estimate the use of resources necessary to carry out the intervention program, as well as the average time to carry out the comprehensive geriatric assessment, and which is the most cost/efficient tool in this case.
- Examine the applicability of a tele-rehabilitation program (ActiveHip) in older adults with hip fracture.
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 (Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 75 years.
- •Diagnosis of frailty hip fracture (those produced by low-impact trauma).
- •Absence of terminal-stage disease
- •Barthel scale score ≥ 60 points.
- •Previous independence for wandering measured as FAC ≥6
- •Capability/Support for using ActiveHip+ app
排除标准
- •Moderate-severe cognitive impairment considered as a Goldberg Global Deterioration Scale score ≥
- •Refusal to sign the informed consent by the patient / main caregiver / legal guardian or inability to obtain it
- •Secondary osteoporosis
- •Nursing home
研究组 & 干预措施
Multicomponent intervention
Experimental
Participants randomly assigned to the Multicomponent intervention group will received a multifactorial intervention.
干预措施: ActiveFLS intervention (Other)
Usual care group
Active Comparator
Participants randomly assigned to the usual care group will received normal outpatient care, including physical rehabilitation when needed.
干预措施: Usual care group (Other)
结局指标
主要结局
Short Physical Performance Battery (SPPB)
时间窗: T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months
The primary endpoint will be the changes measured at baseline and follow-up
次要结局
- Admission and readmission to hospital(T2 1month T3 3 months T4 6 months T5 12 months)
- FAC scale(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- GDS scale(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Number of Participants with Institutionalization(T2 1month T3 3 months T4 6 months T5 12 months)
- Barthel index(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Hand grip stength(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Rate of Frailty(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Lawton index(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Mini- Mental State Examination (MMSE)(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Mini Nutritional Assessment (MNA)(T1 Baseline T2 1month T3 3 months T4 6 months T5 12 months)
- Mortality(T2 1month T3 3 months T4 6 months T5 12 months)
- New fractures(T2 1month T3 3 months T4 6 months T5 12 months)
研究者
研究点 (1)
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