Post Intensive Care Optimization Through Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Aerobic capacity
研究概览
简要总结
The quality of the intensive care unit (ICU) has been steadily improving over the years. Although improvements in the acute treatment of critically ill patients have been made, a large number of ICU survivors suffer from severe physical, cognitive and mental health problems persisting months to years after leaving the ICU. Physical impairments occur the most and can be very severe, greatly affecting activities in daily life and subsequently the perceived quality of life of ICU survivors. Although there is an increased awareness of long-term complaints following ICU stay, there is currently a knowledge gap on how to enhance the recovery of ICU survivors 6 to 12 months post-ICU discharge. The overall objective of the current study is to establish the extent of health and functional improvements that can be obtained with an optimized, combined exercise and nutritional intervention in ICU survivors 6 to 12 months post-ICU discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and older
- •Minimum ICU length of stay of 5 days and/or mechanically ventilated for a minimum of 2 days
- •Persistent physical complaints
- •Community-dwelling, living independently (non-assisted)
- •Mentally competent with a Mini-Mental State Examination (MMSE) score of ≥24
- •Willing to participate in a 20-week multimodal lifestyle intervention
排除标准
- •Any medical condition that may interfere with the safety of the subjects during exercise or any condition that interferes with assessment of the outcome parameters, in the investigators' judgement in consultation with the responsible physician or treating physician/specialist. In case of a contra-indication for MRI (e.g., a pacemaker), subjects will be excluded from this measurement but not necessarily from the study.
- •Any medical condition or circumstance where supplementation with the nutritional supplement is potentially contra-indicated.
- •Known allergy to any of the ingredients present in the nutritional supplement.
- •Simultaneous use of other nutritional supplements during the study period (i.e., unwillingness to stop for the duration of the study).
- •Current participation in other scientific research that conflicts with this study (e.g. intervention studies or weight management studies).
- •No permission to request information from the general practitioner/treating specialist(s) about medical history, medication use.
- •Pregnancy.
结局指标
主要结局
Aerobic capacity
时间窗: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by a VO2-peak test on ergometer
Muscle strength
时间窗: At baseline (week 0), midline (week 11) and at the end of the intervention (week 22)
as measured by 1-RM max testing
Muscle mass
时间窗: At baseline (week 0) and at the end of the intervention (week 22)
as measured by whole-body MRI
次要结局
- Metabolic health(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Body lean mass composition(At baseline (week 0) and at the end of the intervention (week 22))
- Body fat composition(At baseline (week 0) and at the end of the intervention (week 22))
- Brain health (cognitive function)(At baseline (week 0) and at the end of the intervention (week 22))
- Step count(In week 1, week 11 and week 21 of the intervention)
- Age(At baseline (week 0))
- Body mass(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Height(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Body Mass Index(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Waist circumference(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Systolic and diastolic blood pressure(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Handgrip strength(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Functional capacity(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Physical function(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Dietary protein intake(In week 1, week 4 and week 21 of the intervention)
- Dietary carbohydrate intake(In week 1, week 4 and week 21 of the intervention)
- Dietary fat intake(In week 1, week 4 and week 21 of the intervention)
- Gut health(In week 1, week 4 and week 21 of the intervention)
- Muscle fiber size(At baseline (week 0) and at the end of the intervention (week 22))
- Myonuclei quantity(At baseline (week 0) and at the end of the intervention (week 22))
- Proportion (%) of muscle fiber types (type I and type II)(At baseline (week 0) and at the end of the intervention (week 22))
- Frailty(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Quality of Life(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Mental health(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Sleep quality(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Supplement tolerance(At baseline (week 0), midline (week 11) and at the end of the intervention (week 22))
- Intestinal transit rate(In week 1, week 4 and week 21 of the intervention)