Prostate CancerNCT05608746
Prehabilitation in Prostate Cancer Patients, TelePrehabTrial
A study testing Physical Exercise, Pelvic Floor exercise and Sexual counseling in people with Prostate Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Physical Exercise, Pelvic Floor exercise and Sexual counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Physical Exercise, Pelvic Floor exercise, Sexual counseling, Nutritional supplement, Stress management
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ExerciseOther
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.
Pelvic Floor exerciseOther
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.
Sexual counselingOther
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.
Nutritional supplementDietary 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.
Stress managementOther
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.
Standard pre-surgical preparation and pt. information.Other
One week preoperatively the usual regime for the presurgical preparation and information will be followed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Physical Exercise; Other: Pelvic Floor exercise; Other: Sexual counseling; Dietary Supplement: Nutritional supplement; Other: Stress management; Other: Standard pre-surgical preparation and pt. information. |
| Control Group | Other | Not described Receives: Other: Standard pre-surgical preparation and pt. information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
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.
Measured: 12 months
Protocol adherence, assessed by study-specific questionnaire
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.
Measured: 12 months
Number of participants who received the nutritional and mental health intervention.
Total number of participants who after the initial screening, needed the Nutritional and Mental Health intervention.
Measured: 12 months
Retention rate
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.
Measured: 12 months
Secondary outcomes (9)
6-minute-walk-test (6MWT)
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.
Measured: 12 months
30 seconds sit-to-stand test (30STS)
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.
Measured: 12 months
Grip strength test
Grip strength is a measure of muscular strength or the maximum force/tension generated by the forearm muscles.
Measured: 12 months
Self-reported physical activity
A questionnaire measuring physical activity consisting of three questions designed by The Swedish National Board of Health and Welfare (BHW).
Measured: 12 months
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: 12 months
12-Item short form Health Survey (SF-12)
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.
Measured: 12 months
5-Item International Index of Erectile Function (IIEF-5)
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.
Measured: 12 months
24-hour Pad Weigh Test
The 24-hour Pad Weigh Test is used to investigate urinary incontinence.
Measured: 6, 24 and 50 weeks post surgery.
Nutritional Risk Screening
NRS-2002 is a validated tool for nutritional screening of patients between 18 and 90 years of age.
Measured: At baseline (4 weeks before the surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start8 Nov 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Gødstrup Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608746
- Sponsor's protocol ID
- PREHABRHG001
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation in Prostate Cancer Patients Undergoing Nerve Sparring Robot Assisted Radical Prostatectomy.
- ClinicalTrials.gov ID
- NCT05608746
- Acronym / sponsor ID
- PREHABRHG001
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Gødstrup Hospital
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Physical Exercise, Other: Pelvic Floor exercise, Other: Sexual counseling, Dietary Supplement: Nutritional supplement, Other: Stress management, Other: Standard pre-surgical preparation and pt. information. |
| Control Group | Other | Other: Standard pre-surgical preparation and pt. information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ExerciseHome-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 | Intervention Group |
| Pelvic Floor exercisePatients 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 | Intervention Group |
| Sexual counselingPatients 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. | Other | Intervention Group |
| Nutritional supplementPatients 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. | Dietary supplement | Intervention Group |
| Stress managementPatients 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 | Intervention Group |
| 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, Intervention Group |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
6-minute-walk-test (6MWT)
Time frame: 12 months
30 seconds sit-to-stand test (30STS)
Time frame: 12 months
Grip strength test
Time frame: 12 months
Self-reported physical activity
Time frame: 12 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 months
12-Item short form Health Survey (SF-12)
Time frame: 12 months
5-Item International Index of Erectile Function (IIEF-5)
Time frame: 12 months
24-hour Pad Weigh Test
Time frame: 6, 24 and 50 weeks post surgery.
Nutritional Risk Screening
Time frame: At baseline (4 weeks before the surgery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise, Pelvic Floor exercise and Sexual counseling in people with Prostate Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.