Prehabilitation, Prostatectomy, Telemedicine
Conditions
Keywords
Prostatectomy, Physiotherapy, Telemedicine, eHealth, Oncology, Prehabilitation, Rehabilitation
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.
Interventions
OTHERTelemedicine-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.
Sponsors
University Hospital Olomouc
Mobilní fyzioterapie s.r.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Czechia
Contacts
CONTACTPetra Bastlová, Ph.D.
Outcome results
None listed