Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT03308734
Eligibility Criteria:
Inclusion Criteria:
* For this pilot study, we will aim to recruit a total of 30 patients who have been diagnosed with prostate cancer. They will be recruited from a number of Gloucestershire-based sites; a Macmillan Cancer Support initiative called Next Steps, a patient-let prostate cancer support group and the Gloucestershire Hospitals NHS Foundation Trust's uro-oncology specialist nurse service. Participants will be asked to give their written consent to participate in the study. All participants will be given written and verbal information on what the study involves and will be able to ask any questions they may have. The subjects will all be informed that they may withdraw from the study at any point, without giving a reason.
Exclusion Criteria:
* Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension treated with no more than two drugs (either an ACE, ARB, calcium channel blocker, or diuretic)
* Cerebrovascular disease including previous stroke or aneurysm
* History of exercise-induced asthma
* Any prior history of malignancy with the exception of basal cell carcinoma of the skin
* BMI\>35 kg/m¬2
* Uncontrolled hypertension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg after at least a 5 minute seated rest at the screening visit)
* A clinically significant ECG abnormality at the screening visit which in the opinion of the investigators exposes the subject to risk by enrolling in the trial
* Overt contraindications to exercise as determined with a normal resting ECG
* 'Yes' to any questions on a standard physical activity readiness questionnaire (PAR¬Q)
* Classification as highly physically active on the International Physical Activity Questionnaire (IPAQ)
* Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03308734
Study Brief:
Protocol Section:
NCT03308734