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| Name | Class |
|---|---|
| Sheffield Hallam University | OTHER |
| University of Sheffield | OTHER |
| Queen Mary University of London | OTHER |
| University College London Hospitals |
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Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 12 months of aerobic exercise training with behaviour change support |
|
| Comparison | Placebo Comparator | Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic exercise training | Behavioral | Aerobic exercise training will be undertaken for 12 months, combining supervised and independent exercise sessions. Behaviour change counselling will take place bi-monthly, either via face to face sessions during exercise or via telephone by study clinical exercise specialist according to participant preference. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as measured by rate of recruitment | The rate of recruitment will be measured by comparing the number of patients screended to the number of patients recruited. This will allow us to asses if a future full-scale trial is feasible. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as measured by Intervention adherence | Intervention adherence will be assessed using an exercise log book and heart rate monitor to objectively record independent exercise behaviour and support adherence and compliance. | 36 months |
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Inclusion Criteria:
In accordance with NICE active surveillance guidelines, men:
Exclusion Criteria:
Men:
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| Name | Affiliation | Role |
|---|---|---|
| Derek Rosario, MD | University of Sheffield / Sheffield Teaching Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS Trust | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| Institute of Cancer Research, United Kingdom | OTHER |
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| Placebo surveillance and written exercise guidelines | Behavioral | Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |