Effectiveness of a Multimodal and Multidisciplinary Intervention (ESPAI-Fragility) in the Prevention of Sarcopenia, Frailty and Functional Decline in Pre-frail Elderly in the Community. Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 4
- 主要终点
- Muscle Mass
研究概览
简要总结
Frailty is a geriatric syndrome characterized by a decrease in the function of various organs and systems that leads to a greater risk of suffering from diseases or disabilities. Frailty is usually accompanied by weight loss, loss of strength, slowing of walking speed, fatigue and poor physical activity. Frail people have more difficulty in carrying out the usual activities of daily life and a greater risk of needing help to be able to do them.
The aim of this study is to evaluate the safety and effectiveness of an intervention based on the control of chronic diseases, a good use of medicines, diet, physical exercise and good social support, in the prevention . of frailty in old people who are at risk of frailty.
These criteria for participating in the study are why we invite you to participate. Your participation is voluntary. Your decision to participate or not in the study will not affect the medical care you may need. Before making a decision, read this information sheet carefully and ask the person who informs you the questions you want.
In the study there will be two groups, one will receive the study intervention and the other will not receive any special treatment (we call it the control group). The assignment of each individual to one group or the other will take place once you have decided to participate. This assignment will be made at random so that neither you nor your doctor can know "a priori" which group you will be in.
详细描述
General objective:
To assess the effectiveness and safety of a multimodal and multidisciplinary intervention in the prevention of sarcopenia, frailty and functional decline in pre-frail community elders aged 70 years or older.
Specific objectives:
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Evaluate the effect of the study intervention in the medium term (1 year) in terms of prevention or improvement of:
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Muscle strength, muscle mass and sarcopenia,
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The fragility
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Functional capacity (and/or dependence), balance and the risk of falls
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Nutritional status
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The quality of life
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The consumption of health resources in pre-frail community elders 70 years or older.
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To evaluate the safety of the mid-term study intervention (1 year) in pre-frail community elders aged 70 years or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Men or women 70 years of age or older at the time of recruitment
- •That they meet pre-frail phenotype criteria according to L. Fried's criteria
- •That they give their written informed consent to participate in the study.
排除标准
- •Severe dementia (GDS>3)
- •Other neurodegenerative diseases (Parkinson's disease)
- •Neuromuscular diseases
- •Serious psychiatric illness that, at the doctor's discretion, prevents good compliance with the study intervention
- •Active cancer
- •Life expectancy of less than 6 months
- •Institutionalized patient
- •Unstable ischemic heart disease, uncontrolled arrhythmias, dissecting aortic aneurysm, severe aortic stenosis, uncontrolled arterial hypertension (>180/100mmHg), or severe heart failure.
- •Acute diseases or acute or poorly controlled chronic diseases
- •Bone fractures in the last 3 months.
研究组 & 干预措施
Control
Usual clinical practice
Intervention
-
bimonthly personalized follow-up with the appropriate specialists (5 in a year) i
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a program of group activities (6 sessions in a year) with a monitor with the aim of reinforcing adherence to the study intervention and adapting it to the circumstances and the physical, personal and social reality around each participant. The sessions will last approximately one hour and will cover:
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General dietary and hydration recommendations and dietary recommendations for people at risk of malnutrition
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Dietary and physical exercise recommendations in obese elderly
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General physical exercise recommendations in the elderly and physical exercise recommendations in the elderly with sarcopenia
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Physical exercise recommendations for the elderly at risk of falls.
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Medication management and social resources for the elderly in Mataró.
干预措施: Multidisciplinary intervention (Other)
结局指标
主要结局
Muscle Mass
时间窗: baseline, 6 months and 12 months
Bioimpedance
Sarcopenia
时间窗: baseline, 6 months and 12 months
EWGSOP2 description
Frailty
时间窗: baseline, 6 months and 12 months
L Fried Criteria
Muscle strength and/or Muscle function
时间窗: baseline, 6 months and 12 months
Isokinetic
次要结局
- Functional Capacity 2(baseline, 6 months and 12 months)
- Functional Capacity 1(baseline, 6 months and 12 months)
- Functional Capacity 3(baseline, 6 months and 12 months)
- Functional Capacity 4(baseline, 6 months and 12 months)
- Functional Capacity 5(baseline, 6 months and 12 months)
- Functional Capacity 6(baseline, 6 months and 12 months)
研究者
Mateu Serra Prat
MD PhD
Consorci Sanitari del Maresme