Effects of 6 Week Reduced Exertion High Intensity Interval Training Protocol in Patients With Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Bath
- Locations
- 1
- Primary Endpoint
- Cardiorespiratory fitness
Study Overview
Brief Summary
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.
Detailed Description
Background
Among all cancers, the diagnosis of prostate cancer is associated with the greatest number of years lived with the disability and side effects of cancer. The treatment of men with prostate cancer can have a significant adverse effect on physical health. One of the primary treatment modalities is androgen-deprivation therapy which can be associated with reduced muscle mass, strength, fatigue, insulin-resistance, higher rates of cardiovascular morbidity and reduced bone density. Exercise is an increasingly prescribed solution and it has been shown that cardiorespiratory fitness and physical activity have an important survival role but one that is often under-utilised. In terms of mortality, cardiovascular disease is the leading cause of death in patients with prostate cancer and exercise to increase physical activity is recommended in the American College of Sports Medicine's (ACSM) guidelines to counter this, given the clear cardioprotective effects it has.
The World Health Organisation defines the term "physical activity" as "any bodily movement produced by skeletal muscles that requires energy expenditure" and differentiates it from "exercise" which it defines as "a subcategory of physical activity that is planned, structured, repetitive, and purposeful" in order to improve or maintain physical fitness. There is good evidence from a systematic review and meta-analysis that exercise in patients with prostate cancer is safe, improves aerobic fitness and muscular strength, fatigue, body mass composition, quality of life and physical function.
There is no consensus over the detail of exercise prescription in cancer survivors and there are considerable differences between the protocols in studies to date. Many studies have employed moderate intensity activities such as cycling, jogging, walking or using a cross trainer but the frequency and duration employed have not been consistent, ranging from 2 to 7 days a week and 15-60 minutes per session.
Other than duration and frequency, one other important variable in exercise interventions is exercise intensity. The ACSM guidance highlights this as an area where knowledge is lacking and thus where further research is needed. In terms of physical activity in healthy populations, there is believed to be a dose-response relationship of volume with all-cause mortality, however, higher intensity might be able to produce similar results to increasing volume.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For this pilot study, we will aim to recruit a total of 30 patients who have been diagnosed with prostate cancer. They will be recruited from a number of Gloucestershire-based sites; a Macmillan Cancer Support initiative called Next Steps, a patient-let prostate cancer support group and the Gloucestershire Hospitals NHS Foundation Trust's uro-oncology specialist nurse service. Participants will be asked to give their written consent to participate in the study. All participants will be given written and verbal information on what the study involves and will be able to ask any questions they may have. The subjects will all be informed that they may withdraw from the study at any point, without giving a reason.
Exclusion Criteria
- •Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension treated with no more than two drugs (either an ACE, ARB, calcium channel blocker, or diuretic)
- •Cerebrovascular disease including previous stroke or aneurysm
- •History of exercise-induced asthma
- •Any prior history of malignancy with the exception of basal cell carcinoma of the skin
- •BMI>35 kg/m¬2
- •Uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest at the screening visit)
- •A clinically significant ECG abnormality at the screening visit which in the opinion of the investigators exposes the subject to risk by enrolling in the trial
- •Overt contraindications to exercise as determined with a normal resting ECG
- •'Yes' to any questions on a standard physical activity readiness questionnaire (PAR¬Q)
- •Classification as highly physically active on the International Physical Activity Questionnaire (IPAQ)
- •Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study
Outcomes
Primary Outcomes
Cardiorespiratory fitness
Time Frame: Change from baseline Pre- and post- 6-week exercise intervention
Cardiorespiratory fitness using maximal oxygen uptake capacity testing (VO2 max)
Secondary Outcomes
- Arterial stiffness(Change from baseline Pre- and post- 6-week exercise intervention)
- Peripheral blood pressure(Change from baseline Pre- and post- 6-week exercise intervention)
- Central blood pressure and arterial stiffness(Change from baseline Pre- and post- 6-week exercise intervention)
- Tissue saturation index of vastus lateralis and rectus femoris(Change from baseline Pre- and post- 6-week exercise intervention)
- Height(Change from baseline Pre- and post- 6-week exercise intervention)
- Weight(Change from baseline Pre- and post- 6-week exercise intervention)
- Quality of life measure(Change from baseline Pre- and post- 6-week exercise intervention)
- Body composition(Change from baseline Pre- and post- 6-week exercise intervention)
- Reduced-exertion high intensity interval training acceptability questionnaire(Immediately post-6 week exercise intervention)
Investigators
James Turner, Ph.D., FHEA
Principal Investigator, Lecturer in Human Physiology
University of Bath