None listed
Conditions
Brief summary
The purpose of this sub-study is to assess the effects of high intensity aerobic and resistance training plus psychosocial support on cardiovascular function in men with metastatic castrate-resistant prostate cancer (MCRPC). Who is it for? You may be eligible to participate in this sub-study if you are already enrolled in the GAP4 INTERVAL clinical trial (ClinicalTrials.gov ID: NCT02730338) in Queensland. Study details In addition to the requirements of the GAP4 INTERVAL clinical trial, all participants in this sub-study will be asked to attend assessment sessions at the University of Queensland at baseline, 3 months, 6 months, 12 months and 24 months after randomisation into the GAP4 INTERVAL trial. At each of these visits, various measures will be taken in order to assess cardiovascular function, including ultrasound and blood tests. The findings of this sub-study will help in developing safe and effective lifestyle interventions which have the potential to lead to improved clinical practice for men with MCRPC.
Interventions
Men with Metastatic Castrate-resistant Prostate Cancer (MCRPC) who are receiving a tapered high-intensity exercise intervention plus psychosocial support will be observed for 24 months within the larger 'INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)' (Trial ID: NCT02730338) clinical trial. Changes in cardiovascular function will be observed and periodically tested within this 24-month period.
Participants randomised to the intervention a
Men with Metastatic Castrate-resistant Prostate Cancer (MCRPC) who are receiving a tapered high-intensity exercise intervention plus psychosocial support will be observed for 24 months within the larger 'INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)' (Trial ID: NCT02730338) clinical trial. Changes in cardiovascular function will be observed and periodically tested within this 24-month period. Participants randomised to the intervention arm within the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338) will undertake 24 months of high intensity interval training. Participants will be required to complete three one-hour exercise sessions per week in either a university strength and conditioning gym or in the participant’s community/home. Each session will include a combination of high intensity aerobic and resistance exercises. The exercise intervention will taper from fully supervised (month 1), to partially supervised (months 2-12) to fully self-managed (months 13-24). Supervised sessions will either be individual or group-based and will be supervised by an Accredited Exercise Physiologist (AEP). Participants will be provided with tailored exercise programs, designed by an AEP, for the duration of the intervention. These tailored exercise programs will be reviewed after each exercise session and will take into account each participant’s disease-status, exercise performance and exercise preferences. Programs will be delivered via a computer/phone application and thus can be accessed both at the gym and during self-managed sessions. Participants will be instructed on how to use the application during their first supervised training session. Intervention participants will also receive psychosocial support, in the form of monthly newsletters, which will address prostate cancer-specific lifestyle factors/topics e.g. sexual health, dietary guidance.
Sponsors
University of Queensland
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
As participants for the sub-study will be recruited through the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338), the key inclusion criteria have been listed previously in INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL) (Trial ID: NCT02730338). No additional key inclusion criteria are required to be met for involvement in this sub-study.
Exclusion criteria
As participants for the sub-study will be recruited through the GAP4 INTERVAL clinical trial (Trial ID: NCT02730338), the key exclusion criteria have been listed previously in INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL) (Trial ID: NCT02730338). No additional key exclusion criteria are required to be met for involvement in this sub-study.
Outcome results
None listed