Effects of 6 Week Reduced Exertion High Intensity Interval Training Protocol in Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT03308734|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2017
Last Update Posted : October 14, 2019
Prostate cancer is the cause of the greatest number of years lived with disability due to cancer. Treatment for prostate cancer is associated with significant side effects, such as fatigue, loss of muscle mass, strength and reduced quality of life. Cardiovascular disease risk is also increased and accounts for the largest cause of mortality in these patients.
Exercise and physical activity are known to have benefits in patients with prostate cancer but time, motivation and enjoyment are often barriers. Reduced Exertion High-Intensity Interval Training (REHIT) interventions in the general population achieve similar or greater physiological benefits to continuous moderate intensity exercise but for less time commitment. Higher intensity training is also perceived as more enjoyable in both healthy populations and cancer survivors. REHIT could therefore be a potential solution to these barriers.
The aim of this project is to investigate whether a REHIT intervention results in improved cardiorespiratory fitness in patients with prostate cancer. 30 patients will be recruited and randomised to a control group or the intervention group. Both groups will undergo cardiorespiratory fitness testing pre- and post- the 6 week period of the trial. The intervention group will take part in REHIT using maximal oxygen uptake capacity (VO2 MAX) measured on a cycle ergometer. The REHIT intervention will be over 6 weeks, involving 3 sessions per week lasting 10 min and incorporating 2 Wingate sprints of 20 seconds. Pre-intervention values for VO2MAX will be compared to post-intervention values to establish whether REHIT improves cardiorespiratory function in patients with prostate cancer.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Reduced-Exertion High-Intensity Interval Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised Control Trial|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of 6 Week Reduced Exertion High Intensity Interval Training Protocol in Patients With Prostate Cancer|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: Exercise Intervention Group
Reduced-Exertion High-Intensity Interval Training Following baseline testing, participants will start a 6-week training protocol involving reduced-exertion high-intensity training on a cycle ergometer based in a gym in Gloucestershire used by the Macmillan Cancer Support's Next Steps project.
Behavioral: Reduced-Exertion High-Intensity Interval Training
The 6-week REHIT protocol will involve 3 training sessions a week. Each session will include 10 minutes of unloaded pedalling using a cycle ergometer. Volunteers will be asked to increase to their maximal pedal frequency possible for 1-2 seconds prior to applying a resistance of 5 % of pre-training body weight for the Wingate sprint. The sprints will take place at 2 minutes and at 6 minutes. Sprint duration will be increased from 10 seconds in the first week to 15 seconds in the second and third weeks and finally 20 seconds in the remaining weeks. Patients will receive strong verbal encouragement during the sprints after which the resistance will be removed.
Other Name: REHIT
No Intervention: Control Group
Following baseline testing, participants will receive usual care only.
- Cardiorespiratory fitness [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Cardiorespiratory fitness using maximal oxygen uptake capacity testing (VO2 max)
- Peripheral blood pressure [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Peripheral blood pressure using a sphygmomanometer
- Central blood pressure and arterial stiffness [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Central blood pressure will be assessd using pulse wave analysis, a non-invasive assessment described by Wang et al. (2010) using two blood pressure cuffs situated over the brachial and femoral arteries, and a tonometer. Carotid artery stiffness and velocity will be assessed using Doppler ultrasound
- Arterial stiffness [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Carotid artery stiffness and velocity will be assessed using Doppler ultrasound
- Tissue saturation index of vastus lateralis and rectus femoris [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Tissue saturation index of vastus lateralis and rectus femoris muscles will be assessed using continuous wave near infrared spectroscopy.
- Height [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Measured in metres and then aggregated with weight in kilograms to produce BMI in kg/m^2
- Weight [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Measured in kilograms and then aggregated with height in metres to produce BMI in kg/m^2
- Quality of life measure [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Quality of life measure using SF-36®
- Body composition [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]Body composition using air displacement plethysmography in a Cosmed Bod Pod®.
- Reduced-exertion high intensity interval training acceptability questionnaire [ Time Frame: Immediately post-6 week exercise intervention ]The acceptability of the training will be assessed with a questionnaire based on that used by (Boereboom et al., 2016).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308734
|Gloucestershire Care Services NHS Trust|
|Gloucester, United Kingdom|
|Principal Investigator:||James Turner, PhD||University of Bath|