Effect of Individual Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Energy intake
研究概览
简要总结
Malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. Nutritional therapy co-management is recommended for both diagnoses.
This study investigates the efficacy of individualized nutrition therapy (iNT) in pulmonary rehabilitation. Patients at significant risk for malnutrition already receive iNT within clinical routine during rehabilitation. The investigators will investigate if patients with only mild to moderate risk of malnutrition and possible sarcopenia also benefit from iNT.
详细描述
The participating patients are randomly assigned to two groups after giving written consent.
The intervention group receives individual counseling by nutrition therapists twice a week in addition to the usual rehabilitation program. The iNT determines the energy and protein needs of the patients and creates targeted individual measures to achieve them. Measures may include, for example, adjustments to the meal plan or nutritional supplementation. The measures are continuously adapted to the patients' needs.
The control group also receives soup fortified with a standard amount of protein and fat and, if needed, an energy- and protein-rich dessert option as part of the rehabilitation routine care for patients at risk for malnutrition. However, patients from the control group do not receive additional counseling or adjustment by the iNT.
Patients' energy and protein intake will be recorded on three subsequent days at start of rehabilitation and at three subsequent days before discharge. Average duration of rehabilitation is expected to be three weeks. As primary outcome, change in energy intake will be compared between groups. Additionally, change in protein intake and other follow-up parameters of nutritional status and sarcopenia will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Patients cannot be blinded due to the nature of the intervention. However, the personnel involved will be blinded to the collection of the primary endpoint. In order to be able to blind the nutritional calculations of the primary endpoint, the logged amounts of food eaten will be recorded on the neutral eating cards, on which the study group allocation will not be apparent.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to rehab due to chronic obstructive pulmonary disease or after a pneumonia
- •light to moderate risk of malnutrition (Nutritional Risk Score-2002: 3-4 Points)
- •risk of sarcopenia (sarc-f >=4)
- •signed informed consent
排除标准
- •medically described nutritional support
- •reasons (cognitive, language) that prevent a informed consent
- •enteral or parenteral nutrition
- •after bariatric surgery
研究组 & 干预措施
usual care
Usual care: Participants in the control group receive a standardized food fortification of the soups with fat and protein, as well as an energy- and protein-rich dessert. No additional advice or adjustments are made by the iNT.
individual nutrition therapy
Individualized nutrition therapy: Specialists in nutritional counseling determine the patient's individual energy and protein needs and create targeted individual measures to achieve them. Measures can include, for example, adjustments to the menu, food enrichment or supplementation. The measures are discussed with the patients on an ongoing basis and adjusted as necessary.
干预措施: individual nutritional therapy (Other)
结局指标
主要结局
Energy intake
时间窗: From admission to discharge (2-3 weeks)
Change in energy intake \[kcal\] from start to end of rehabilitation.
次要结局
- time up and go(From admission to discharge (2-3 weeks))
- lean body mass(From admission to discharge (2-3 weeks))
- grip strength(From admission to discharge (2-3 weeks))
- protein intake(From admission to discharge (2-3 weeks))
研究者
Thimo Marcin
Head of Reseach Department
Berner Reha Zentrum AG