Hyperproteic Oral Supplementation With Vitamin D and Resistance Training in Older Patients Admitted to the Acute Unit (SERIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Mini Nutritional Assessment (MNA)
研究概览
简要总结
This is a randomised, parallel, single-blind clinical trial. Objectives: to evaluate: the impact of the intervention on nutritional status, body composition, strength, the prevalence of sarcopenia and physical performance at discharge and three months later..
详细描述
Design: A randomised controlled clinical trial with four parallel groups is being conducted with older adults admitted to an acute geriatric unit at risk of malnutrition or with malnutrition. The participants are randomly assigned to one of the groups. Three assessment visits are being conducted: at admission, discharge, and three months later.
Setting: The study is being conducted in the Unidad de Agudos del Servicio de Geriatría at Hospital Universitario Ramón y Cajal, by the Servicio Madrileño de Salud (SERMAS).
Interventions: four groups: 1) a resistance training group (RT); 2) an oral nutritional supplementation group (ONS); 3) a combination of RT and ONS (RT+ONS); and a control group (CG). The patients in the RT group follow individualized RT sessions with a physiotherapist daily during the hospitalization and three weekly home sessions on their own after discharge. The sessions are structured according to the recommendations of the American College of Sports Medicine (ACSM), mainly RT.
Study population: A study of malnourished or at-risk outpatients in our setting was used to calculate the sample size. In that study, with an alpha error of 0.05 and a beta of 0.80, the minimum sample size was 14 participants per group. Our objective is to include, at least, 21 participants per group, resulting in a total of 84 participants.
Sociodemographic and clinical variables are being collected (e.g., age, sex, living situation, number of drugs, falls). Information about nutritional and functional status (e.g., MNA, gait speed, Barthel, Lawton, and FAC), body composition (e.g., weight, height, body mass index, appendicular muscle mass index measured by bioimpedanciometry (BIA)), ultrasound measurements of the anterior rectus (area, thickness, and penation angle), and muscle strength (hand grip test) is also collected.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Ultrasound measurements, MNA and bioimpedance are being performed at all three visits by an investigator blinded to the assigned group. In addition, the person carrying out the data analysis will also be blinded to the assigned group.
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
- •Patients admitted to the Unidad de Agudos (Geriatric Acute Care) del Servicio de Geriatría at HU Ramón y Cajal who are at risk of malnutrition or malnutrition (defined with a MNA-SF score ≤ 11) and who sign the informed consent form.
排除标准
- •patients with estimated discharge within 72 hours.
- •Re-admissions (defined as previous admission in the Geriatric Acute Care in the last 3 months)
- •Patients taking ONS for more than two weeks.at the time of admission.
- •Patients suffering any illness or condition that prevents or contraindicates resistance physical exercise. and oral food intake.
- •Food allergies or intolerances that contraindicate the SNO.
- •Patients with advanced dementia (GDS stage 7) or palliative care.
结局指标
主要结局
Mini Nutritional Assessment (MNA)
时间窗: 12 weeks
Screening tool to help identify malnourished elderly people or those at risk of malnutrition on a scale of 0 to 30. The higher the value, the better the nutritional status of the older adult.
次要结局
- Hand grip test(12 weeks)
- Barthel's index(12 weeks)
- Body Mass Index (BMI)(12 weeks)
- Appendicular Skeletal Muscle mass Index (ASMI)(12 weeks)
- 4-m-test(12 weeks)
- Lawton-Brody scale(12 weeks)
- Functional Ambulation Classification (FAC)(12 weeks)
- Cross-sectional area(12 weeks)
- Thickness(12 weeks)
- Penile angle of a muscle(12 weeks)