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临床试验/NCT05413616
NCT05413616招募中不适用

The Effect of a Combined Personalized Nutritional Intervention and a Personalized Graded Activity Functional Training Program on Physical Performance in Hospitalized Older Patients, Compared to Usual Care: A Randomized Clinical Trial

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2022年7月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
136
试验地点
1
主要终点
Change in Timed Up & Go

研究概览

简要总结

This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance and is continued after discharge in the home care setting, supported by an e-health application.

详细描述

Rationale: The older hospitalized population is growing and specifically at risk for decreased muscle mass and physical functioning and has a negative influence on activities of daily living, independence, quality of life, re-admissions, and nursing home placement. Current knowledge shows that a physical activity training programs consisting of tailored resistance and endurance exercise can improve muscle mass in healthy elderly. Nutritional interventions in conjunction with physical activity based on individual protein requirements, high quality protein and timing of protein intake can further stimulate muscle protein synthesis. The effect of a combined nutritional intervention with physical activity in healthy individuals and athletes has been studied before, but not in older hospitalized patients. A personalized combined physical activity program and a nutritional intervention could be a solution and is an exciting emerging field of research with the potential to dramatically improve patient outcomes.

The average hospital admittance is 4 to 5 days in which the prevention of the decline in muscle mass and physical performance can be initiated but not improved. Thus, the translation of a prolonged combined intervention to home care is essential. To support the combined personalized nutritional intervention and physical exercise intervention during hospitalization and home care, an eHealth application for and with older patients can be beneficial.

Objective: This project aims to improve physical performance in older patients, by offering a personalized combined nutritional intervention with a physical activity training program. The intervention starts at hospital admittance, and is continued after discharge in the home care setting, supported by an e-health application.

Study design: The study will be performed as a randomized clinical trial. Study population: The study population hospitalized adult patients of ≥65 years, living in the Nijmegen area within the Radboud University Medical Centre.

Intervention: One group receives a personalized nutritional intervention by a dietician combines with a functional training program by physical therapists. The nutritional intervention focuses on adequate protein intake, type, and timing of protein. The exercise program will make use of goal setting throughout the intervention period to optimize the training effect . The control group will receive usual care.

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
None

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 years
  • •Living within the Nijmegen area (within 40km)
  • •Admitted to clinical ward of Radboudumc or CWZ
  • •Understanding and speaking of the Dutch language
  • •Mentally competent
  • •Signed informed consent

排除标准

  • •Complete use of tube feeding or parenteral nutrition
  • •Renal insufficiency (MDRD-GFR < 30ml/min)

研究组 & 干预措施

Standard care

No Intervention

FITFOOD lifestyle intervention

Experimental

Lifestyle intervention consisting of both a nutritional and exercise intervention.

干预措施: FITFOOD lifestyle intervention (Behavioral)

结局指标

主要结局

Change in Timed Up & Go

时间窗: Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.

TUG

次要结局

  • Change in muscle strength(Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.)
  • Change in activities of daily living(Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.)
  • Risk for Sarcopenia(Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.)
  • Clinical outcomes: length of hospital stay(24 weeks after baseline)
  • Clinical outcomes: re-admission(24 weeks after baseline)
  • Clinical outcomes: mortality(24 weeks after baseline)
  • Change in nutritional status(Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.)
  • Medical consumption(12 weeks after baseline, 24 weeks after baseline)
  • Change in nutritional intake (energy, protein).(Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.)
  • Change in movement according to actometer(Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.)
  • Change in Short Physical Performance Battery(Baseline, 1 day before hospital release, 4 weeks after baseline, 12 weeks after baseline, 24 weeks after baseline.)
  • Change in muscle mass(Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.)
  • Change in quality of life(Baseline, 1 day before hospital release, 12 weeks after baseline, 24 weeks after baseline.)
  • Clinical outcomes: complications(24 weeks after baseline)
  • Medical consumption(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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