Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility - enrolment (75% consent rate target) and protocol adherence
研究概览
简要总结
To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children.
详细描述
This is a single centre, Pilot RCT that will evaluate in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children. We will conduct a qualitative substudy to evaluate caregiver impressions of the intervention, and to understand barriers and facilitators to implementing early mobilization in critically ill children.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 3 years to < 18 years;
- •Limited to bed-rest or bed mobility at time of screening
- •expected PICU stay for an additional 48 hours minimum, at time of screening
- •informed consent and or assent where appropriate;
- •agreement of the most responsible PICU physician.
排除标准
- •Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine
- •Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath
- •Cycle ergometer does not fit body dimensions
- •Already mobilizing well/expected to mobilize out of bed within 24h
- •not expected to survive current admission - i.e. predicted hospital mortality of > 90%;
研究组 & 干预措施
Cycle ergometry
Participants will receive In-bed cycling for 30 minutes per day in addition to Usual Care, until the physiotherapist deems that the patient is mobilizing well, or a maximum of 7 days (whichever comes first).
干预措施: In-bed cycling (Device)
Usual care
Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization
干预措施: Usual Care (Other)
结局指标
主要结局
Feasibility - enrolment (75% consent rate target) and protocol adherence
时间窗: 7 days
Feasibility is defined as the ability to screen and enrol eligible patients (75% consent rate target).Protocol adherence will be defined as the ability to apply in-bed cycling intervention within 24 hours of consent, and the ability to apply 30 minutes of in-bed cycling daily during week days. We will also measure the rates and reasons for protocol suspensions, violations and study withdrawal.
次要结局
- Adverse event rate(7 days)