Supported resistance training for prostate cancer patients

ISRCTN	ISRCTN10490647
DOI	https://doi.org/10.1186/ISRCTN10490647
Secondary identifying numbers	31496

Submission date: 24/10/2016
Registration date: 26/10/2016
Last edited: 16/12/2021

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-exercise-to-help-with-the-side-effects-of-prostate-cancer-treatment

Contact information

Ms Ruth Ashton
Public

University of Derby
School of Human Science
Derby
DE22 1GB
United Kingdom

ORCID ID	0000-0001-6282-0352
Phone	+44 (0)1332 593398
Email	r.ashton@derby.ac.uk

Prof John Saxton
Scientific

Head, Department of Sport, Exercise and Rehabilitation
Room 259 Northumberland Building
Health & Life Sciences
City Campus
Northumbria University
Newcastle upon Tyne
NE1 8ST
United Kingdom

Phone	+44 (0)191 227 3371
Email	john.saxton@northumbria.ac.uk

Study information

Study design	Randomised; Both; Design type: Treatment, Physical, Rehabilitation, Qualitative
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Supported progressive resistance exercise for countering the adverse side effects of prostate cancer treatment
Study objectives	The aim of this study is to develop and/or assess the effects of home-based progressive resistance exercise programmes following radical prostatectomy and androgen deprivation therapy in prostate cancer patients.
Ethics approval(s)	South East Scotland REC 02, 08/09/2016, ref: 16/SS/0143
Health condition(s) or problem(s) studied	Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract
Intervention	Phase 1: Patients, treated via radical prostatectomy or androgen-deprivation therapy, will be recruited for a 2 month window. The will be asked to complete a questionnaire booklet every day for a 2 week period. The questionnaire booklet will contain validated questionnaires, including the Scottish Physical Activity Questionnaire (SPAQ), Brief Fatigue Inventory and the Stage of Change questionnaire as well as asking about current health issues. A stamped addressed return envelope will also accompany the questionnaire booklet. Phase 1 will help to inform the subsequent phases of the project. Phase 2: Phase 2 will involve small groups of ~6 men at a time invited to The Freeman Hospital for exercise programme development sessions. All patients will have been treated for prostate cancer via radical prostatectomy or androgen-deprivation therapy. These sessions will be broken down into three sections 1. Patient discussion: This involves asking both radical prostatectomy and androgen-deprivation therapy patients about their physical activity levels and their opinions on a proposed exercise study. 2. Pilot work: Initially patients will be able to look at the equipment and try some exercises. Patients will then be shown 2 exercises per major muscle group and they will have the opportunity to try these exercises whilst having measures of heart rate, blood pressure and perceived exertion taken. 3. Patient feedback: Patients will be asked about the feasibility of the exercises and equipment in the home setting and which exercises they prefer. The researcher will use this information to develop a resistance training programme that can be transferred to the home environment. The researcher aims to complete at least 3 initial sessions to establish a programme and 3 follow-up sessions to provide feedback on the programme therefore approximately 40 patients will be recruited. The programme developed will be trialled in phase 3. Phase 3: Phase 3 will involve sixty patients, who have previously undergone radical prostatectomy, being randomised into one of two groups (control vs intervention). The control group will be instructed to continue with usual care but will be offered some supervised exercise sessions after completion of the study. The intervention group will also continue with usual care alongside a supported progressive resistance exercise programme. Blocked randomisation, stratified for age, will be used to ensure that the overall order of testing is balanced (ratio 1:1). Randomisation will be undertaken by an independent person not directly involved with the trial after completion of the baseline assessments. All outcome measures will be assessed in all participants (control and intervention) at baseline (0 weeks), mid-way (13 weeks) and on completion of the trial (25 weeks). The intervention group will be asked to complete 3 resistance exercise sessions each week for 24 weeks. During the first week all 3 sessions will be supervised. In week 2, 2 of the sessions will be supervised and 1 will be home-based (i.e., unsupervised). During weeks 3 and 4, 1 session will be supervised and 2 completed at home. All supervised session will take place in a designated room at The Freeman Hospital. During weeks 5 to 12, aIl sessions will be unsupervised, but participants (intervention only) will receive regular telephone/email/text message (via Florence) contact from a member of the research team from week 2. During weeks 13-24, all sessions will be unsupervised and there will be no contact from the research team. The control group will be asked to continue with their usual activity levels. Both groups will use an exercise diary to record their activity levels. Usual care will not be affected by this trial.
Intervention type	Other
Primary outcome measure	Phase 1 and 2 are purely developmental work and no specific outcome measures are collected. Phase 3: Endothlial function will be assessed through flow-mediated dilation. This will be measured at baseline (0 weeks), mid-way (13 weeks) and on completion of the trial (25 weeks).
Secondary outcome measures	Phase 3: All secondary outcomes will be measured at baseline (0 weeks), mid-way (13 weeks) and on completion of the trial (25 weeks). 1. Aerobic exercise tolerance will be assessed using the BSU/Bruce ramp protocol 2. Upper and lower-limb strength will be assessed using the senior fitness test: arm curl and the sit-to-stand test performed using a chair with a seat 45 cm above the ground 3. Glucose and insulin levels and blood lipid profile are measured using venous blood samples and are analysed by the hospital laboratory 4. Body composition is assessed by calculating body mass index (BMI) from height and weight measurements, skinfolds using skinfold calipers and waist measurements using a body composition tape measure. 5. Blood pressure and heart rate are measured using a stethoscope, sphygmomanometer and heart rate monitor. 6. Generic and specific quality of life will be assessed using the EQ5D and FACT-P with fatigue assessed using the Brief Fatigue Inventory 7. Risk of suffering from a heart attack or stroke in the next 10 years will be analysed using the Q-Risk assessment
Overall study start date	19/01/2016
Completion date	25/09/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	Planned Sample Size: 140; UK Sample Size: 140
Total final enrolment	40
Key inclusion criteria	Phase 1 1. Prostate cancer patients treated with radical prostatectomy or androgen-deprivation therapy 2. Able to provide consent 3. Able to read and speak English to a level allowing satisfactory completion of written questionnaires unless an interpreter is available Phase 2 and 3 1. Prostate cancer patients treated with radical prostatectomy or androgen-deprivation therapy 2. Able to provide consent 3. Able to read and speak English to a level allowing satisfactory completion of written questionnaires unless an interpreter is available 4. All men will have been previously cardiac assessed and undergone a cardio-pulmonary exercise test (CPET) for major surgery (within 4 months)
Key exclusion criteria	Phase 1 Receiving other treatments for prostate cancer. Phase 2 1. Receiving other treatments for prostate cancer 2. Participation in another clinical trial where concurrent participation is deemed inappropriate. Phase 3 1. Participation in another clinical trial where concurrent participation is deemed inappropriate 2. Receiving any other treatment for cancer 3. Planned further surgery within the first 3 months after being randomly assigned to a group 4. Unsuitable for resistance exercise training based on opinion of the clinical investigator
Date of first enrolment	19/10/2016
Date of final enrolment	28/04/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Freeman Hospital

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Northumbria University Newcastle
Hospital/treatment centre

Mea House
City Campus
Newcastle Upon Tyne
NE1 8ST
England
United Kingdom

"ROR"	https://ror.org/049e6bc10

Funders

Funder type

Charity

Urology Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): TUF
Location: United Kingdom

Results and Publications

Intention to publish date	28/02/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Current as of 06/01/2021: All data will be written up as part of a PhD thesis and publications may arise from this. All data to be submitted for publication by January 2020
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from r.ashton@derby.ac.uk Previous: All data will be written up as part of a PhD thesis and publications may arise from this. All data to be published from this research will be done so by January 2019 IPD sharing plan: The datasets generated during and/or analysed during the current study are/will be available upon request from john.saxton@northumbria.ac.uk

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/01/2021	25/01/2021	Yes	No
Plain English results		15/12/2021	16/12/2021	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

16/12/2021: The Cancer Research UK lay results summary has been added.
25/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
06/01/2021: The following changes were made to the trial record:
1. Contact details, publication and dissemination plan and IPD sharing statement updated.
2. The intention to publish date was changed from 30/06/2020 to 28/02/2021.
18/12/2020: Internal review.
18/09/2019: The public contact's details have been changed.
22/07/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 28/10/2018 to 25/09/2018.
2. The intention to publish date was changed from 31/01/2019 to 30/06/2020.
03/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2018 to 28/04/2018.
2. The overall trial end date was changed from 28/09/2018 to 28/10/2018.
26/03/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2018 to 30/03/2018.
2. The overall trial end date was changed from 31/08/2018 to 28/09/2018.
3. The intention to publish date was changed from 31/12/2018 to 31/01/2019.
16/10/2017: Cancer Help UK lay summary link added to plain English summary field.