Specialty: Renal disorders, Primary sub-specialty: Renal disorders
Conditions
Interventions
Phase 1:
Patients, treated via radical prostatectomy or androgen-deprivation therapy, will be recruited for a 2 month window. The will be asked to complete a questionnaire booklet every day for a 2 we
Sponsors
Northumbria University Newcastle
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Phase 1 1. Prostate cancer patients treated with radical prostatectomy or androgen-deprivation therapy 2. Able to provide consent 3. Able to read and speak English to a level allowing satisfactory completion of written questionnaires unless an interpreter is available Phase 2 and 3 1. Prostate cancer patients treated with radical prostatectomy or androgen-deprivation therapy 2. Able to provide consent 3. Able to read and speak English to a level allowing satisfactory completion of written questionnaires unless an interpreter is available 4. All men will have been previously cardiac assessed and undergone a cardio-pulmonary exercise test (CPET) for major surgery (within 4 months)
Exclusion criteria
Exclusion criteria: Phase 1 Receiving other treatments for prostate cancer. Phase 2 1. Receiving other treatments for prostate cancer 2. Participation in another clinical trial where concurrent participation is deemed inappropriate. Phase 3 1. Participation in another clinical trial where concurrent participation is deemed inappropriate 2. Receiving any other treatment for cancer 3. Planned further surgery within the first 3 months after being randomly assigned to a group 4. Unsuitable for resistance exercise training based on opinion of the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1 and 2 are purely developmental work and no specific outcome measures are collected. Phase 3: Endothlial function will be assessed through flow-mediated dilation. This will be measured at baseline (0 weeks), mid-way (13 weeks) and on completion of the trial (25 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 3: All secondary outcomes will be measured at baseline (0 weeks), mid-way (13 weeks) and on completion of the trial (25 weeks). 1. Aerobic exercise tolerance will be assessed using the BSU/Bruce ramp protocol 2. Upper and lower-limb strength will be assessed using the senior fitness test: arm curl and the sit-to-stand test performed using a chair with a seat 45 cm above the ground 3. Glucose and insulin levels and blood lipid profile are measured using venous blood samples and are analysed by the hospital laboratory 4. Body composition is assessed by calculating body mass index (BMI) from height and weight measurements, skinfolds using skinfold calipers and waist measurements using a body composition tape measure. 5. Blood pressure and heart rate are measured using a stethoscope, sphygmomanometer and heart rate monitor. 6. Generic and specific quality of life will be assessed using the EQ5D and FACT-P with fatigue assessed using the Brief Fatigue Inventory 7. Risk of suffering from a heart attack or stroke in the next 10 years will be analysed using the Q-Risk assessment | — |
Countries
England, United Kingdom
Contacts
Public ContactRuth Ashton
Outcome results
None listed