Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes in Mobility
研究概览
简要总结
This trial studies the impact of early mobility tracked with a 3-dimensional (3D) motion tracking technology (XSENS) on post-surgery recovery in patients undergoing oncologic surgeries. Xsens uses wireless measurements which could be used in clinical settings to objectively measure movement patterns (the joint range of movement and the distance of movement) during functional activities. Post-surgery mobility tracking may help doctors to identify the minimum required level of mobility after inpatient oncologic surgeries to enhance early post-surgery recovery and decrease early post-surgery complications.
详细描述
PRIMARY OBJECTIVES:
I. To investigate objectively using evidence based randomized controlled trial the impact of early mobility (first day after the surgery) after any inpatient oncologic procedures on early recovery of postoperative course.
II. Try to find out the minimum level of postoperative mobility that needed for early postoperative course recovery by objective assessment of range of movement for each participant using 3D motion tracking system (Xsens).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Ambulant inpatient with a stay of >= 2 days after any inpatient oncologic surgery
- •Eastern Cooperative Oncology Group (ECOG) scale of performance status of less than 3
- •American Society of Anesthesiologist score (ASA) 3 or less
- •Participants who do not engage in regular exercise regimen before the surgery (other than regular occupational physical therapy)
- •Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Patients with altered mental status
- •Patients with psychiatric illness
- •ECOG scale performance status 3 or more
- •ASA score of 4
- •Participants who engage in regular exercise regimen before surgery (at least one session per week)
- •Patients with restricted movement due to other diseases
- •Patients who require continuous monitoring
结局指标
主要结局
Changes in Mobility
时间窗: Baseline up to 30 days post discharge
changes in mobility (as measured by average velocity of pelvis) from baseline to discharge are compared between groups using a one-sided, two-sample t-test.
Early Return of Bowel Motion
时间窗: Up to 30 days after discharge
Days from operation to passing flatus and/or stool, treated as continuous measure
Presence or Absence of Chest Symptoms
时间窗: Up to 30 days after discharge
Presence or absence of chest symptoms (cough, sputum, and ability of using incentive spirometry), treated as a binary variable
Surgical Related Complications and Readmissions
时间窗: Up to 30 days after discharge
Presence or absence of surgical complication (including readmission), treated as a binary variable
Early Discharge From the Hospital
时间窗: Up to 30 days after discharge
Days from operation until hospital discharge, treated as continuous variable
Presence or Absence of Nausea and/or Vomiting
时间窗: Up to 30 days after discharge
Presence or absence of nausea and/or vomiting, treated as a binary variable
次要结局
- Mobility Quality of Life Questionnaire(Up to 3 months post discharge)
- Post-surgical Complications(Up to 30 days post discharge)
- Application of Sensors in a Hospital Setting(Up to 3 months post discharge)
- Range of Joint Movement in Upper and Lower Joints of Body(Up to 30 days after discharge)
- Change in Exercise Habits Outside of the Hospital(Up to 3 months post discharge)