The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Balance Test Composite Score
研究概览
简要总结
The study titled " The effectiveness of telemedicine monitoring prehabilitation in prostate cancer patients undergoing radical prostatectomy " investigates the impact of a structured telemedicine-supported prehabilitation and rehabilitation program on reducing postoperative urinary incontinence in patients with localized prostate cancer. Radical prostatectomy, a common treatment for localized prostate cancer, is often associated with complications such as urinary incontinence, which significantly affects quality of life. This study aims to address this issue by enhancing patients' physical conditioning and adherence to pre- and postoperative rehabilitation through the use of wearable devices and remote physiotherapy consultations.
详细描述
Participants in the intervention group will receive a comprehensive prehabilitation program starting 30 -14 days before surgery. They will be equipped with wearable devices (smartwatch and tablet/mobile phone) to monitor physical activity, including parameters like step count and heart rate, allowing for tailored exercise regimens focused on specific daily activity goals. These participants will also have access to educational videos and online consultations with physiotherapists for ongoing support. The program is designed to optimize physical readiness for surgery and improve postoperative recovery outcomes, with continuous monitoring and notifications provided to encourage adherence to the prescribed activities. The control group will receive printed educational materials with general preoperative exercise guidance. This group will have digital monitoring of physical activity, but patients will not receive any reminders or prompts to complete their exercises, they will not have access to online consultations. The primary endpoint of the study is the reduction of urinary incontinence as measured by the 24-hour pad test at 30 days before the surgery and 6 weeks, 3 and 6 months post-surgery. Secondary endpoints include assessments of physical fitness, quality of life, respiratory and postural function, and adherence to the rehabilitation protocol. Both groups will follow structured postoperative follow-ups with physiotherapists at defined intervals to monitor recovery progress and adjust the rehabilitation protocol as necessary. The study spans approximately 6 months for each participant, aiming to generate critical insights into the benefits of telemedicine in enhancing surgical recovery and improving patient outcomes in prostate cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-confirmed localized prostate cancer (ICD code C.61).
- •Indicated for radical prostatectomy, with or without pelvic lymphadenectomy (ePLND).
- •Not previously treated for prostate cancer, including radiation therapy to the pelvis, major pelvic surgery, or placement of a penile implant or artificial urinary sphincter.
- •No known urethral stricture or colostomy or chronic urinary catheterization.
- •No medical or current psychiatric disorders that precludes their participation in the study.
- •Status of the musculoskeletal system allowing physical exercise.
- •Urinary continent at baseline.
- •Has reliable internet and the skills/knowledge to use technologies use for the study.
排除标准
- •Other malignant tumors, except for benign skin carcinoma.
- •Active treatment for other oncological diagnoses.
- •Presence of preoperative urinary incontinence.
- •Diagnosed mental or cognitive disorders.
- •Prior pelvic radiotherapy or hormone therapy for prostate cancer recurrence.
- •Severe musculoskeletal disorders preventing active exercise
- •Inability to use required technologies
研究组 & 干预措施
Control Group (Standard Preoperative and Postoperative Care)
Preoperative Phase:
Wearable Technology: Participants receive wearable devices (smartwatch, tablet or phone) for real-time monitoring of physical activity parameters (step count, heart rate, general activity).
Physical Exam & Physiotherapy: Physiotherapist evaluates musculoskeletal function, provides verbal education on pelvic floor muscle activity, posture, and respiratory exercises; scheduled 2-4 weeks pre-surgery.
Printed Educational Material: Participants receive printed booklets containing general information, exercises, and activity guidelines to prepare for surgery.
Telemonitoring (No Notifications): Activity digitally monitored, without sending reminders or prompts for exercise adherence.
Postoperative Phase:
Physiotherapy Visits: Scheduled at 3 weeks, 4 weeks, 6 weeks, 3 months, and 6 months post-surgery for progress assessment and rehabilitation adjustments.
Data Collection: Continuous collection of objective data from wearable devices compared to intervention group.
Telemedicine-Supported Prehabilitation and Rehabilitation
Preoperative Phase:
Wearable Technology: Smartwatch monitoring steps, heart rate, and activity. Physical Exam & Physiotherapy Session: Musculoskeletal evaluation, pelvic floor training via sonographic feedback, posture/respiratory exercises (2-4 weeks pre-surgery).
Activity Guidelines: Specific daily step targets and exercises to optimize surgical readiness.
Educational Support: Videos demonstrating pelvic floor training, posture, breathing, and exercises.
Remote Monitoring & Notifications: Continuous monitoring with inactivity alerts/reminders.
Online Consultations: Virtual physiotherapy sessions for feedback and plan adjustments.
Postoperative Phase:
Physiotherapy Visits: At 3, 4, 6 weeks; 3, 6 months post-surgery for assessment and rehab adjustments.
Telemonitoring: Continued wearable monitoring, video consultations, and access to educational videos.
Data Collection: Objective wearable data collected to track progress, adherence, and personalize rehab.
干预措施: Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools. (Other)
结局指标
主要结局
Balance Test Composite Score
时间窗: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Score from a standardized balance assessment (Berg Balance Scale). Higher scores indicate better balance. Unit of Measure: Score Range: 0-56
Reduction in Early Postoperative Incontinence
时间窗: Baseline evaluated at 30 days before surgery. Evaluated at 6 weeks, 3 months, and 6 months post-surgery.
Measured by the 24-hour pad weight test.
Lower Limb and abdominal Muscle Strength (Isometric)
时间窗: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Isometric strength of targeted muscle groups measured using dynamometer. Unit of Measure: Newtons (N)
Time to full Continence Recovery
时间窗: 3 - 6 months post-surgery
Time to achieve full continence following surgery (no pads)
Six-Minute Walk Test Distance
时间窗: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Distance that a participant is able to walk in 6 minutes on a hard, flat surface. Unit of Measure: Meters
次要结局
- EPIC-CP Total Score(Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery)
- EQ-5D-5L Index Score(Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery)
- Forced Expiratory Volume in One Second (FEV1)(2 weeks pre-surgery, 3 and 6 months pos-surgery)
- Maximal Voluntary Ventilation (MVV)(2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery)
- Daily Step Count(2 weeks pre-surgery, 3 months and 6 months post-surgery)
- Daily Physical Activity Duration(2 weeks pre-surgery, 3 and 6 months post-surgery)