Multidisciplinary Prehabilitation Management Pathway and Network Platform Construction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- 6 minute walking test distance, 6MWD
研究概览
简要总结
The goal of this clinical trial is to learn if "Prehabilitation model for Internet+ devices"improve patients' preoperative status and reduce the postoperative recovery time, postoperative complications，comparing to trditional prehabilitation model. The main questions it aims to answer are:
- Does the Prehabilitation model for Internet+ devices works out?
- Does"Prehabilitation model for Internet+ devices" better increase the patient's six-minute walk test distance?
Participants will:
Take Internet+devices model or traditional model to prehabilitation for 2-4weeks.
Test 6MWT before operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Block randomized number will be prepared in advance and be hidden in the envelope. At the time of collecting the participants' baseline information, neither the participants nor the investigator knew which intervention the patients would receive. After the information was collected, the envelopes were opened to determine whether participants were assigned to the intervention or control group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-75 years;
- •adults with suspected lung cancer proposed for VATS lobectomy/sublobar resection.
排除标准
- •Patient refusal;
- •ASA classification IV or higher;
- •Pre-neoadjuvant chemotherapy;
- •Inability to cooperate (psychiatric abnormalities, impaired consciousness, mental retardation);
- •Comorbidities cannot tolerate home rehabilitation or functional motor examination;
- •Inability to use a smartphone or read Chinese;
- •Average weekly moderate-intensity/high-intensity exercise of >90min/>60min.
结局指标
主要结局
6 minute walking test distance, 6MWD
时间窗: About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery
Using 6MWD as the primary assessment of patients' perioperative functional status and the primary endpoint of the study, patients were evaluated at enrollment, before surgery, and 30 days after surgery, respectively.
次要结局
- grip(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- Hospital Anxiety and Depression Scale（HADS）(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- NRS2002 Nutritional Risk Screening(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- postoperative complication(30 days after surgery)
- World Health Organization Disability Assessment Schedule 2.0（WHODAS 2.0）(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- Length of hospitalization(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- Quality of Recovery-15（QOR-15）(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
- pulmonary function(About 2-4 month before surgery(When deciding on surgery), 1 day before surgery, 30 days after surgery)
研究者
ZIJIA LIU
associate chief physician
Peking Union Medical College Hospital