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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
A combination of wearable technology, activity guidelines, educational support, remote monitoring with notifications and consultations with physiotherapists.
Urology clinic, University hospital Olomouc
Olomouc, Czechia
Reduction in Early Postoperative Incontinence
Measured by the 24-hour pad weight test.
Time frame: Baseline evaluated at 30 days before surgery. Evaluated at 6 weeks, 3 months, and 6 months post-surgery.
Time to full Continence Recovery
Time to achieve full continence following surgery (no pads)
Time frame: 3 - 6 months post-surgery
Six-Minute Walk Test Distance
Distance that a participant is able to walk in 6 minutes on a hard, flat surface. Unit of Measure: Meters
Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Balance Test Composite Score
Score from a standardized balance assessment (Berg Balance Scale). Higher scores indicate better balance. Unit of Measure: Score Range: 0-56
Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Lower Limb and abdominal Muscle Strength (Isometric)
Isometric strength of targeted muscle groups measured using dynamometer. Unit of Measure: Newtons (N)
Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
EPIC-CP Total Score
Patient-reported outcome measuring health-related QoL in domains relevant to prostate cancer, using the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher scores indicate worse QoL. Unit of Measure: Score (0-60)
Time frame: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
EQ-5D-5L Index Score
EuroQol (Quality of Life)-5 Dimensions Health status measure based on five dimensions of functioning. Score derived using country-specific value sets. Higher scores represent better health status. Unit of Measure: Score (range: -0.59 to 1)
Time frame: Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery
Forced Expiratory Volume in One Second (FEV1)
FEV1 represents the volume of air that can be forcibly exhaled in the first second of a forced breath. Measurements will be performed using calibrated spirometry according to ERS guidelines. FEV1 is a standard measure of pulmonary function. Higher values indicate better lung function. Unit of Measure: Liters
Time frame: 2 weeks pre-surgery, 3 and 6 months pos-surgery
Maximal Voluntary Ventilation (MVV)
MVV is the maximum amount of air a participant can inhale and exhale within a specific time frame (12 seconds), extrapolated to one minute. Testing will be conducted using standard spirometry under ERS guidelines. MVV reflects respiratory muscle endurance and ventilatory capacity. Unit of Measure: Liters/minute
Time frame: 2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery
Daily Step Count
Average number of steps recorded per day using a wearable device. Unit of Measure: Steps/day
Time frame: 2 weeks pre-surgery, 3 months and 6 months post-surgery
Daily Physical Activity Duration
Average duration of physical activity (e.g., moderate to vigorous activity) recorded per day using wearable device. Unit of Measure: Minutes/day
Time frame: 2 weeks pre-surgery, 3 and 6 months post-surgery
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