A Randomized, Controlled Trial to Evaluate if Pedometer-Guided Coaching Can Promote Postoperative Ambulation After Abdominopelvic Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Adherence to ambulation goal
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate whether remote pedometer follow-up and virtual coaching can improve ambulation after major abdominopelvic surgery, and how this affects key postoperative outcomes.
The main questions it aims to answer are:
- Does pedometer-guided ambulation coaching increases ambulation after surgery?
- Does pedometer-guided coaching improve satisfaction, quality of recovery, while reducing postoperative complications?
Participants will be asked to install a pedometer app for the purpose of data sharing. Study personnel will compare pedometer follow-up plus text message coaching (intervention) with pedometer follow-up only (control) to investigate whether coaching improves adherence to the postoperative ambulation recommendation, and whether this leads to improvement of the secondary outcomes.
详细描述
Ambulation is not only a key component for improved postoperative recovery, studies have also found associations between the degree of ambulation in the early postoperative period and postoperative morbidity. Additionally, A preoperative sedentary lifestyle has been associated with a higher incidence of complications and readmissions after surgery . Our team conducted a systematic review, which found that perioperative pedometer readings were captured in 64-94% of the patients, and pedometer data were linked to a number of important perioperative outcomes including; complications; length of stay; and unplanned readmission. Several studies have demonstrated that inpatient pedometer-guided exercise programs could improve postoperative ambulation. However, this is limited by the length of hospital stay. In this study, the aim is to investigate the efficacy of pedometer-based coaching for post-discharge ambulation.
This is a randomized controlled trial with a 1:1 allocation ratio. Participants will be randomly allocated to either pedometer follow-up (control) or pedometer follow-up with 3 times per week ambulation coaching through texts (intervention). Participants will be screened and consented before surgery. All recruited subjects will have a pedometer app installed on their phone during the preoperative clinic visit, during which the purpose of the app and potential risks will be explained.
After surgery and confirmation of the postoperative criteria, participants will enter the study and undergo randomization through a automated system.
Postoperatively , participants in the control arm will have pedometer data collected over postoperative days 8-30. The participants in the interventional arm will also have the pedometer data collected, while additionally being provided feedback in the form of text message every Monday, Wednesday and Friday.
Pedometer data:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Pedometer data collection and coaching text administration will be done by an unmasked team member.
30-day interview will be done by a masked team member.
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
- •Adult subjects ≥18 years at screening
- •Subjects undergoing major abdominopelvic surgery under general anesthesia, expected to last more than 3 hours from induction of anesthesia to anesthesia stop time.
- •Able to understand the study procedures and voluntarily provide study informed consent
- •Agree to be followed up for the duration of the study period
- •Has access to a smart phone with app compatibility
- •Planned inpatient stay for 1 night or more
排除标准
- •Subjects undergoing liver surgery or upper gastrointestinal surgery
- •Refusal to install the app/ deleted app before end of the monitor period
- •Subjects who are unable to walk at baseline
- •Medical contraindications for unrestricted ambulation
- •Patients with spinal or lower limb pathology, chronic or poorly controlled pain potentially preventing full postoperative ambulation
- •Neurological impairment precluding unrestricted ambulation Cognitive impairment precluding consent or follow up study activities
- •Patients who require any mobility aid at baseline
- •Subjects discharged to a rehab facility or never discharged from the hospital alive
- •Hospital length of stay > 1 week
- •Patient not cleared by physical therapy for unrestricted ambulation on discharge
结局指标
主要结局
Adherence to ambulation goal
时间窗: Postoperative day 8 to day 30
Proportion of days on which patient met the ambulation goal
次要结局
- Sleep(Postoperative day 8 to day 30)
- 30-day Duke Activity Status Index (DASI) score(Postoperative day 8 to day 30)
- 30-day Quality of Recovery -15 (QoR-15) score(Postoperative day 8 to day 30)
- Unplanned hospital visits(Postoperative day 8 to day 30)
- Patient satisfaction(Postoperative day 8 to day 30)
- Technical issue with the app or the follow up(Postoperative day 8 to day 30)
- Postoperative delirium(Day of surgery to day of discharge (up to 7 days after surgery))
研究者
Sergio D. Bergese
Director of Outcomes and Clinical Research in Perioperative Medicine
Stony Brook University