The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy

Not Applicable

Not yet recruiting

• Conditions: Prostatectomy; Prehabilitation; Telemedicine

• Registration Number: NCT06981026
• Lead Sponsor: University Hospital Olomouc

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-03-18
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2026-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Early Postoperative Incontinence	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)	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	3 - 6 months post-surgery	Time to achieve full continence following surgery (no pads)
Six-Minute Walk Test Distance	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
Balance Test Composite Score	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

Secondary Outcome Measures

Name	Time	Method
EPIC-CP Total Score	Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery	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)
EQ-5D-5L Index Score	Baseline (30 days before surgery), 6 weeks, 3 months, and 6 months post-surgery	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)
Forced Expiratory Volume in One Second (FEV1)	2 weeks pre-surgery, 3 and 6 months pos-surgery	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
Maximal Voluntary Ventilation (MVV)	2 weeks pre-surgery, 3 months post-surgery, and 6 months post-surgery	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
Daily Step Count	2 weeks pre-surgery, 3 months and 6 months post-surgery	Average number of steps recorded per day using a wearable device.; Unit of Measure: Steps/day
Daily Physical Activity Duration	2 weeks pre-surgery, 3 and 6 months post-surgery	Average duration of physical activity (e.g., moderate to vigorous activity) recorded per day using wearable device.; Unit of Measure: Minutes/day

Trial Locations

Locations (1)

Urology clinic, University hospital Olomouc; 🇨🇿 Olomouc, Czechia