Older Adult Safety in Surgery (OASIS) - Can a Preoperative Self-Reported Functional Status Information Improve Prediction of Cardiac Mobility Related Complications That Threaten Patient Safety In Older Adult Surgical Patients?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Distance
研究概览
简要总结
Use of remote coaching and walking plan prior to surgery to improve stamina and mobility in frail older adult surgical patients after surgery.
详细描述
Surgery is a life-saving procedure for patients with cancer and can enhance quality of life for patients with intractable abdominal, urologic, thoracic, or other major disease. Although most patients tolerate the procedure well, frail older adults have as much as a threefold increase in the risk of adverse outcomes after surgery. The proposal will assess the role of a walking intervention in the surgical context over multiple dimensions of physical status-endurance, balance, gait speed, strength, and self-reported function. The investigators will be collecting data on patients who may be undergoing any abdominal, urologic, thoracic, or other major surgery.
The investigators will be introducing a home walking prescription where subjects will self-monitor the amount of walking with use of a fit-bit type wristband pedometer. Via remote coaching and use of the pedometer, the investigators hope to increase the amount of steps over a period of time prior to surgery. A research grade monitor will then be utilized in order to be able to track steps post surgery during the hospital stay. By increasing movement pre and post surgery, the investigators hope to demonstrate that such a program can reduce the incidence of adverse outcomes or improve physical status assessments such as endurance, balance, gait speed, strength, and self-reported function. Patients will be randomized in a 1:1 fashion into intervention and control groups using a prespecified table generated by our study statistician.
Intervention patients will receive a walking prescription and weekly calls from a study staff member. Patients will be given a pedometer to be worn on their wrist, a phone , and a phone charger. Patients will be instructed to synchronize their pedometer to the provided phone once a day. For three days following the baseline visit, patients will be instructed to walk their usual amount. A study staff member will then provide the initial walking prescription based on the participants' baseline performance on the three of baseline walking and will focus the participant on walking at a moderate intensity (level of approximately 3 on the modified Borg Perceived Exertional Scale;14 laminated Borg scales will be distributed to participants).
Participants may walk steps over the course of a day or in one session. The initial walking prescription will also provide instructions to the participant to increase his/her number of steps each week by 10 to 20%.
Study Visits for intervention subjects. Baseline visit (consent)- If agree to participate in the study this group will receive weekly phone calls from a study staff member until the surgery. Following the baseline visit, subjects will also be seen during their preoperative surgical evaluation visit, on the day of their surgery, on approximately the third or fourth day following the surgery or date of discharge if length of stay is less than three days, at approximately 30 days following surgery and a phone call approximately 6 months following the surgery.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 and older
- •Undergoing any abdominal, thoracic, urologic, or other major surgery
- •Independently ambulatory
- •Patient should be within 3-8 weeks of surgery
- •Estimated length of hospital stay after surgery two days or more
排除标准
- •for screening:
- •Non-adults
- •Prisoners
- •Non-English language speaker for whom short form consent is not available
- •Exclusion criteria for randomized controlled trial:
- •Unstable angina or stable angina with minimal exertion or at rest
- •Visual impairment such that walking impairs safety
- •Fall within previous three months
- •Resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, or a diastolic blood pressure of more than 100 mm Hg
- •Patient who does not walk independently (e.g. wheel chair; cane walking is okay)
结局指标
主要结局
6 Minute Walk Distance
时间窗: 21-45 Days
Change from baseline 6MWD to 6MWD on day of discharge
次要结局
- Change in The Veterans Rand 12-Item Health Survey (VR12), baseline to 4 wks and 6 months(7 weeks to 27 weeks)
- 6MWD baseline to presurgical appointment day(3-6 weeks)
- Step counts on Post Op days 1 and 2(2 days)
- Baseline to 4 weeks post surgery 6MWD(7-10 weeks (Baseline can be anywhere between 3 to 6 weeks pre-surgery, therefore 4 weeks post surgery can be anywhere from 7 weeks after baseline to 10 weeks after baseline))
研究者
J. Matthias Walz
Chair of Anesthesiology & Perioperative Medicine
University of Massachusetts, Worcester
