Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information



Primary contact

Dr Luke Robles


Contact details

NIHR Bristol BRC Nutrition Theme
Level 3
University Hospitals Bristol Education and Research Centre
Upper Maudlin Street
United Kingdom
+44 117 342 1765

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

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).

Ethics approval

East Midlands – Nottingham 2 Research Ethics Committee, ref:17/EM/0446, 31/01/2018

Study design

Two arm randomised control feasibility study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

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.

Intervention type



Drug names

Primary outcome measure

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


Reason abandoned (if study stopped)


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

Participant type


Age group




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

United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
BS10 5NB
United Kingdom

Sponsor information


University of Bristol

Sponsor details

Senate House
Tyndall Avenue
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Bristol Biomedical Research Centre (Nutrition Theme)

Alternative name(s)

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 30/09/2019.

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/09/2019: Lucy Hackshaw-McGeagh has been replaced as the trial contact by Luke Robles. 05/08/2019: Internal review. 21/06/2019: Internal review. 05/04/2019: Internal review. 05/03/2019: Internal review. 11/02/2019: Hilary Taylor has been replaced as the trial contact by Lucy Hackshaw-McGeagh. 07/06/2018: Internal review 14/05/2018: Internal review. 09/03/2018: The following changes have been made: 1. Details of ethics approval have been added. 2. Recruitment start date has changed from 01/11/2017 to 01/04/2018 3. Recruitment end date has changed from 21/02/2018 to 20/08/2018 4. Overall trial end date has changed from 30/04/2018 to 30/09/2018 5. Intention to publish date has changed from 30/04/2019 to 30/09/2019 07/03/2018: Hilary Taylor was added as primary study contact 16/01/2018: Internal review.