Prehabilitation in Prostate Cancer Patients, TelePrehabTrial

April 3, 2025 updated by: University of Aarhus

Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.

Localized prostate cancer is commonly treated with radical prostatectomy (RP). Following surgery adverse effects such as urinary incontinence, erectile dysfunction associated with decreased quality of life and decreased physical function are common.

Traditionally, interventions to reduce these adverse effects are introduced postoperatively. However, a growing body of literature shows the benefit of interventions prior to surgery to enhance treatment success, known as prehabilitation.

Hence, the main purpose of this study is to develop and investigate the feasibility of prehabilitation using telehealth, to implement several interventions prior to elective RP.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Regional Hospital Goedstrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male > 18 years
  • Diagnosed with prostate cancer and referred to robot assisted nerve sparring RP
  • Adequacy in written and spoken Danish
  • Cognitively well-functioning
  • Able to understand the study procedures and willing to provide signed informed consent

Exclusion Criteria:

  • Severe comorbidities that would prevent the patient from exercising, e.g. recent fractures, severe heart disease or neurological disorders.
  • No possibility to use a smartphone or tablet.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: Physical Exercise
Home-based individualized training, consisting of unsupervised aerobic exercise and resistance exercise, with moderate intensity. The pt. receives an exercise manual and exercise videos online, through an APP.
Other: Pelvic Floor exercise
Patients will be assessed by a physiotherapist and instructed in a pelvic floor exercise program, accessed through the APP. Furthermore, the pt. is provided with general information about pelvic floor anatomy and muscle function.
Other: Sexual counseling
Patients will be provided with 1 video-consultation with a clinical sexologist, during the prehabilitation period. The patients will be instructed in strategies to improve postoperative communication regarding, sex, realistic expectations, erectile dysfunction and the use of aids.
Dietary supplement: Nutritional supplement
Patients are systematically screened for malnutrition to assess the nutritional status. Patients are given recommendations with dietary advice online, through the APP. If the patient is at nutritional risk, the patient is provided with a nutritional supplement.
Other: Stress management
Patients are systematically screened for anxiety and depression. If patients are at risk of anxiety or depression, they are referred to a consultation with a nurse, who will provide information and strategies to handle the uncertainties they may experience.
Other: Standard pre-surgical preparation and pt. information.
One week preoperatively the usual regime for the presurgical preparation and information will be followed.
Other: Control Group
Other: Standard pre-surgical preparation and pt. information.
One week preoperatively the usual regime for the presurgical preparation and information will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 12 months
Percentage of eligible patients who accepted to participate in the study. Recruitment rate is measured by dividing the number of patients consented by the number of patients screened.
12 months
Protocol adherence, assessed by study-specific questionnaire
Time Frame: 12 months
The pt. will every week register his adherence to the intervention protocol. The number of intervention components which were not fulfilled during the prehabilitation period will be counted, and the percentage of deviation will be calculated compared to the total number of intervention components.
12 months
Number of participants who received the nutritional and mental health intervention.
Time Frame: 12 months
Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.
12 months
Retention rate
Time Frame: 12 months
Percentage of participants completing the full prehabilitation period, and full follow-up after the surgery. Retention rate is measured by dividing the number of patients completing the study with the number of patients consented.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute-walk-test (6MWT)
Time Frame: 12 months
The 6MWT is a performance-based sub-maximal exercise test, used to assess aerobic capacity and endurance. The test covers the distance a person can walk on a 30-meters walkway, in the time of 6 minutes.
12 months
30 seconds sit-to-stand test (30STS)
Time Frame: 12 months
30STS test is used to assess the leg strength and endurance. The test discovers how many times a person is able to rise up and sit down from a chair within 30 seconds.
12 months
Grip strength test
Time Frame: 12 months
Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.
12 months
Self-reported physical activity
Time Frame: 12 months
A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).
12 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 months
Hospital Anxiety and Depression Scale is a questionnaire used to identify anxiety disorders and depression among patients in nonpsychiatric hospital clinics. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
12 months
12-Item short form Health Survey (SF-12)
Time Frame: 12 months
The SF-12 is a short form of the 36-Item Short-form Health Survey (SF-36). It contains 12 items, and is a patient-reported survey of the patient's perception of health related quality of life, during the last 4 weeks.
12 months
5-Item International Index of Erectile Function (IIEF-5)
Time Frame: 12 months
IIEF-5 is an abridged five-item version of the International Index of Erectile Function. It is a self-administered, multi-dimensional measure of erectile function.
12 months
24-hour Pad Weigh Test
Time Frame: 6, 24 and 50 weeks post surgery.
The 24-hour Pad Weigh Test is used to investigate urinary incontinence.
6, 24 and 50 weeks post surgery.
Nutritional Risk Screening
Time Frame: At baseline (4 weeks before the surgery).
NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.
At baseline (4 weeks before the surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Gødstrup Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREHABRHG001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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