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Effects of 6 Week Reduced Exertion High Intensity Interval Training Protocol in Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308734
Recruitment Status : Active, not recruiting
First Posted : October 13, 2017
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
James Turner, Ph.D., FHEA, University of Bath

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Reduced-Exertion High-Intensity Interval Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Peripheral blood pressure [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]
    Peripheral blood pressure using a sphygmomanometer

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. Quality of life measure [ Time Frame: Change from baseline Pre- and post- 6-week exercise intervention ]
    Quality of life measure using SF-36®

  8. 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®.

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only patients with prostate cancer will be eligible and therefore this study will only include male patients.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308734


Locations
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United Kingdom
Gloucestershire Care Services NHS Trust
Gloucester, United Kingdom
Sponsors and Collaborators
University of Bath
Investigators
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Principal Investigator: James Turner, PhD University of Bath
Publications:
Ware, J.E., Snow, K.K., Kosinski, M., Gandek, B. SF-36® Health Survey Manual and Interpretation Guide. Boston, MA: New England Medical Center, The Health Institute, 1993
World Health Organisation, 2010. Global Recommendations on Physical Activity for Health. [Online] Available from: http://apps.who.int/iris/bitstream/10665/44399/1/9789241599979_eng.pdf [Accessed: 11/04/2017]

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Responsible Party: James Turner, Ph.D., FHEA, Principal Investigator, Lecturer in Human Physiology, University of Bath
ClinicalTrials.gov Identifier: NCT03308734    
Other Study ID Numbers: Prostate REHIT
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Turner, Ph.D., FHEA, University of Bath:
High-intensity interval training
REHIT
Prostate cancer
cardiorespiratory fitness
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases