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

NCT ID: NCT06981026

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-09-30

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.

Conditions

Prostatectomy; Prehabilitation; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.

Intervention Type: OTHER

A combination of wearable technology, activity guidelines, educational support, remote monitoring with notifications and consultations with physiotherapists.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telemedicine-based prehabilitation and postoperative rehabilitation protocol, including physical activity monitoring, respiratory and postural training, and guidance via telehealth tools.

A combination of wearable technology, activity guidelines, educational support, remote monitoring with notifications and consultations with physiotherapists.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Mobilní fyzioterapie s.r.o.

UNKNOWN

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Urology clinic, University hospital Olomouc

Olomouc, , Czechia

Countries

Czechia

Central Contacts

Petra Bastlová, Ph.D.

Role: CONTACT

Petra.Bastlova@fnol.cz

+420 588 442 628

Facility Contacts

Ondřej Česák, M.D.

Role: primary

Ondrej.Cesak@fnol.cz

+420 588 445 708

Other Identifiers

CZ.02.01.01/00/23_021/0008829

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OP JAK ITI VZ 2

Identifier Type: -

Identifier Source: org_study_id