Implications of physical activity on CPET in a prostate cancer sample

ISRCTN	ISRCTN86024738
DOI	https://doi.org/10.1186/ISRCTN86024738
Secondary identifying numbers	2839

Submission date: 22/09/2017
Registration date: 13/10/2017
Last edited: 14/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Luke Robles
Public

NIHR Bristol BRC Nutrition Theme
Level 3, University Hospitals Bristol Education and Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

ORCID ID	0000-0003-2882-9868
Phone	+44 117 342 1765
Email	luke.robles@bristol.ac.uk

Study information

Study design	Two arm randomised control feasibility study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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(s)	East Midlands – Nottingham 2 Research Ethics Committee, ref:17/EM/0446, 31/01/2018
Condition	Localised prostate cancer
Intervention	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	Behavioural
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 study start date	12/06/2017
Overall study end date	30/09/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target number of participants	20
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 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	01/04/2018
Recruitment end date	20/08/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southmead Hospital

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

Sponsor information

University of Bristol
University/education

Senate House
Tyndall Avenue
Bristol
BS8 2PS
England
United Kingdom

"ROR"	https://ror.org/0524sp257

Funders

Funder type

Government

NIHR Bristol Biomedical Research Centre (Nutrition Theme)

No information available

Results and Publications

Intention to publish date	30/09/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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 plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

14/09/2022: Internal review.
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.