Feasibility randomised controlled trial to explore implications of a physical activity intervention on Cardiopulmonary Exercise Testing (CPET) and other outcomes in men with localised prostate cancer prior to radical prostatectomy
The aim of this study is to explore the impact of moderate-vigorous physical activity on anaerobic threshold, in men with localised prostate cancer, as measured by Cardiopulmonary Exercixe Testing (CPET).
Not provided at time of registration.
Two arm randomised control feasibility study
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Localised prostate cancer
Participants are randomised (1:1) into a physical activity intervention arm or the control arm. This is carried out using a computer generated programme by a member of university staff unrelated to the research study.
Men in the intervention arm are asked to carry out moderate-vigorous physical activity. Participant interventions are asked to walk at a brisk pace for 30 minutes, on at least 5 days a week, on top of normal physical activity, with the additional aim to walk 10,000 steps every day. Participants are provided with a wrist worn activity monitor which provide real time feedback and motivational reminders. The participants are instructed to do this by the research nurse at their research appointment. They are asked to carry out the intervention from randomisation until their surgery which are approximately 4-6 weeks in duration.
Participants in the control arm are asked to carry on with normal physical activity. Baseline takes place at randomisation, follow up is done just prior to surgery approx. 4-6 post randomisation.
Primary outcome measures
CPET quantitative measures for fitness pre- and -post exercise intervention are measured using peak oxygen uptake (VO2) and surrogate measures of lung efficiency of ventillatory equivalents for CO2 and O2, as well as the AT
Quantitative measures for fitness pre- and -post exercise intervention will include peak oxygen uptake (VO2) and surrogate measures of lung efficiency of ventilatory equivalents for CO2 and O2 measured using Cardiopulmonary exercise testing (CPET) monitoring at baseline and prior to surgery (approx. 4-6 weeks post randomisation / baseline).
Secondary outcome measures
1. Effects on markers of proliferation and metabolic pathways, including p AMPK/AMPK, p IGF-I receptor/ IGF-I receptor, FASN, PTEN, IGFBP-2, Ki67 and pACCA/ ACCA are measured using blood and prostate tissue at baseline and prior to/during surgery (approx. 4-6 weeks post randomisation/baseline)
2. Randomisation rates are measured using the proportion of eligible men approached who agree to be randomised baseline
3. Retention rates measured using the number of participants successfully followed-up, as a proportion of those who were randomised just prior to surgery (approx. 4-6 weeks post randomisation/baseline)
4. Change in prostate specific antigen (PSA) level collected via blood sample at baseline and prior to surgery (approx. 4-6 weeks post randomisation/baseline)
5. Change in insulin-like growth factor (IGF-I) level collected via blood sample at baseline and prior to surgery (approx. 4-6 weeks post randomisation / baseline)
6. Change in Quality of life collected via validated questionnaire (The Functional Assessment of Cancer Therapy – Prostate subscale (FACT-P) and Functional Assessment of Chronic Illness Therapy – Fatigue subscale (FACIT-F) questionnaires) at baseline and prior to surgery (approx. 4-6 weeks post randomisation/baseline)
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Localised prostate cancer
2. Be due to undergo radical prostatectomy
3. Be due to receive treatment at Southmead Hospital, North Bristol NHS Trust
4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience
5. Be aged 18 or over, there is no upper age limit
6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level
7. Be physically able to undergo the brisk walking intervention and CPET static bike assessment
Target number of participants
Participant exclusion criteria
1. Inability to give informed consent or unavailability for follow-up
2. Being identified as unsuitable to participate following guidance of their clinician
3. The use of a mobility aid other than a walking stick that would prevent them from carrying out the brisk walking intervention
4. Any co-morbidities or other reason for not being able to participate in any aspect of the intervention
5. Participants already achieving physical activity levels over the physical activity intervention level
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Southmead Road Westbury-on-Trym
NIHR Bristol Biomedical Research Centre (Nutrition Theme)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal and via national and international conferences at approximately 30/04/2019.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting