PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 190
- 主要终点
- Change in Physical Function (6-Minute Walk Test) from baseline to before surgery.
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a prehabilitation program using wearable technology can improve physical function and postoperative outcomes in elderly patients (65 years or older) undergoing major elective non-cardiac surgery. The main questions it aims to answer are:
Does the prehabilitation program improve physical function, as measured by the 6-minute walk test (6MWT), from baseline to pre-surgery? Does the prehabilitation program reduce postoperative complications and enhance recovery? Researchers will compare participants who receive the prehabilitation program with wearable technology (intervention group) to those receiving standard preoperative care (control group) to see if the intervention results in greater improvements in physical function and postoperative outcomes.
Participants will:
Follow a personalized exercise program monitored remotely via telemedicine. Wear a Fitbit Aspire 3 device to track vital signs such as heart rate and physical activity.
Undergo assessments of physical function and quality of life before surgery.
详细描述
This clinical trial aims to investigate the effectiveness of a prehabilitation program using wearable technology to improve physical function and postoperative outcomes in elderly patients undergoing major elective non-cardiac surgery. The intervention group will receive a comprehensive preoperative rehabilitation program (swSEP) that includes personalized exercise regimens monitored via telemedicine and a wearable device (Fitbit Aspire 3) to track key physiological metrics such as heart rate, physical activity, and sleep patterns. The exercise program will consist of three components: strength training, aerobic exercises, and flexibility exercises. These sessions will be conducted three times per week, with adjustments made by the physiotherapist based on the participant's progress and vital sign responses.
Participants will be monitored closely through telemedicine check-ins twice per week to ensure adherence to the exercise program, address any challenges, and make modifications to the regimen as needed. In addition, all participants will undergo baseline functional assessments, including the 6-minute walk test (6MWT), 30-second sit-to-stand test (30sSTS), handgrip strength (HGS), and maximal inspiratory pressure (MIP), as well as nutritional and quality of life assessments using the MUST score and EQ-5D-5L questionnaire. These assessments will be repeated 1-3 days before surgery to evaluate any improvements in physical function.
The control group (uSEP) will receive standard preoperative care, which includes physiotherapy education and a home-based exercise booklet, but will not be provided with a wearable device or telemedicine supervision. Both groups will be monitored for postoperative outcomes, including the incidence of complications classified by the Clavien-Dindo system, hospital length of stay, ICU admissions, and hospital readmissions. Health-related quality of life (HRQoL) will also be measured at multiple time points.
Exploratory analyses will include postoperative recovery and resumption of physical activity at 12 weeks post-surgery, as well as heart rate variability (HRV) data from the wearable devices to assess physiological responsiveness to the prehabilitation program and its potential predictive value for postoperative outcomes. A qualitative interview study will be conducted concurrently to explore the barriers and facilitators of home-based prehabilitation from the perspectives of both patients and healthcare providers.
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
Blinding The investigators will not be blinded, as they will be responsible for prescribing the intervention bundle to participants in the intervention arm. However, hospital staff, including nurses and surgeons, will be blinded to the allocation of study arms. It is acknowledged that maintaining full blinding for the treating team in the postoperative period may be challenging, as study details could potentially be disclosed by participants who are not blinded. Efforts will be made to minimise such disclosures to preserve blinding where possible.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frail elderly patients aged 65 years or older.
- •Scheduled to undergo major elective, non-cardiac surgery.
- •Anticipated surgery duration of over two hours or expected blood loss greater than 500 mL.
- •Frailty status with Edmonton Frail Scale (EFS) score of 6 or higher.
- •Capacity to provide informed consent independently.
- •Available at least two weeks before surgery to participate in the prehabilitation program.
- •Ability to follow exercise instructions independently.
- •Ownership of a smartphone with Bluetooth and cellular connectivity.
排除标准
- •Severe comorbidities that interfere with participation in the exercise program (e.g., unstable angina, severe aortic stenosis, or uncontrolled arrhythmias).
- •Cognitive impairments that prevent understanding or adherence to the intervention.
研究组 & 干预措施
Control
Participants in the control group (uSEP) will receive the standard PREPARE program provided by the hospital, which includes preoperative physiotherapy education and a home exercise booklet (Supplementary Material: Educational Materials). This unsupervised, home-based programme consists of full-body aerobic, resistance, and respiratory exercises that participants will perform independently at home. Additionally, participants with a Maximal Inspiratory Pressure (MIP) of less than 100 cmH₂O will be given an Inspiratory Muscle Trainer (IMT) to enhance respiratory function.
Intervention
Participants in the intervention group (swSEP) will receive standard preoperative physiotherapy education in addition to a Fitbit Aspire 3 wearable device, which will track vital signs such as heart rate, physical activity, and sleep patterns. They will follow a personalised exercise program that is remotely supervised by a physiotherapist via telemedicine twice a week. The exercise regimen will consist of 20-minute sessions, at least three times per week, and will include three core components: strength training, aerobic exercise, and flexibility exercises. Strength training will involve 2-3 sets of full-body exercises, including combinations of upper body, lower body, and abdominal movements. Aerobic exercises will be performed at a minimum intensity of 40% of the participant's maximal heart rate (HRmax) for up to 20 minutes. Flexibility training will include six stretches, each held for 20 seconds and repeated twice, targeting the chest, arms, legs, and trunk.
干预措施: Supervised prehabilitation programme (Device)
结局指标
主要结局
Change in Physical Function (6-Minute Walk Test) from baseline to before surgery.
时间窗: baseline to 1-3 days pre-surgery.
The primary outcome of this study will be the change in physical function from baseline to 1 to 3 pre-surgery, measured by the 6-minute walk test (6MWT).
次要结局
- Functional assessments(Baseline to 1-3 days before the surgery)
- Postoperative complications(Preoperative to up to 4 weeks after surgery.)
- Health Services outcomes(Preoperative to up to 8 weeks after surgery.)
研究者
Ke Yuhe
Associate Consultant
Singapore General Hospital