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

NCT03308734 | Withdrawn

• 1 other identifier: Prostate REHIT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

High-intensity interval training; REHIT; Prostate cancer; cardiorespiratory fitness

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness

  Cardiorespiratory fitness using maximal oxygen uptake capacity testing (VO2 max)

  Change from baseline Pre- and post- 6-week exercise intervention

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Following baseline testing, participants will receive usual care only.

Interventions

Reduced-Exertion High-Intensity Interval Training BEHAVIORAL

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.

Also known as: REHIT

Exercise Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only patients with prostate cancer will be eligible and therefore this study will only include male patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

Gloucestershire Care Services NHS Trust

Gloucester, United Kingdom

Location

Related Publications (28)

• Adamsen L, Quist M, Andersen C, Moller T, Herrstedt J, Kronborg D, Baadsgaard MT, Vistisen K, Midtgaard J, Christiansen B, Stage M, Kronborg MT, Rorth M. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial. BMJ. 2009 Oct 13;339:b3410. doi: 10.1136/bmj.b3410.

  PMID: 19826172 BACKGROUND

• Bartlett JD, Close GL, MacLaren DP, Gregson W, Drust B, Morton JP. High-intensity interval running is perceived to be more enjoyable than moderate-intensity continuous exercise: implications for exercise adherence. J Sports Sci. 2011 Mar;29(6):547-53. doi: 10.1080/02640414.2010.545427.

  PMID: 21360405 BACKGROUND

• Boereboom CL, Phillips BE, Williams JP, Lund JN. A 31-day time to surgery compliant exercise training programme improves aerobic health in the elderly. Tech Coloproctol. 2016 Jun;20(6):375-382. doi: 10.1007/s10151-016-1455-1. Epub 2016 Mar 25.

  PMID: 27015678 BACKGROUND

• Bourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, Albertsen PC, Tombal B, Payne HA, Rosario DJ. Exercise for Men with Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2016 Apr;69(4):693-703. doi: 10.1016/j.eururo.2015.10.047. Epub 2015 Nov 26.

  PMID: 26632144 BACKGROUND

• Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle. Part II: anaerobic energy, neuromuscular load and practical applications. Sports Med. 2013 Oct;43(10):927-54. doi: 10.1007/s40279-013-0066-5.

  PMID: 23832851 BACKGROUND

• Despres JP. Physical Activity, Sedentary Behaviours, and Cardiovascular Health: When Will Cardiorespiratory Fitness Become a Vital Sign? Can J Cardiol. 2016 Apr;32(4):505-13. doi: 10.1016/j.cjca.2015.12.006. Epub 2015 Dec 15.

  PMID: 26907579 BACKGROUND

• Devin JL, Sax AT, Hughes GI, Jenkins DG, Aitken JF, Chambers SK, Dunn JC, Bolam KA, Skinner TL. The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial. J Cancer Surviv. 2016 Jun;10(3):467-79. doi: 10.1007/s11764-015-0490-7. Epub 2015 Oct 19.

  PMID: 26482384 BACKGROUND

• Ferrer RA, Huedo-Medina TB, Johnson BT, Ryan S, Pescatello LS. Exercise interventions for cancer survivors: a meta-analysis of quality of life outcomes. Ann Behav Med. 2011 Feb;41(1):32-47. doi: 10.1007/s12160-010-9225-1.

  PMID: 20931309 BACKGROUND

• Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.

  PMID: 22289907 BACKGROUND

• Gillen JB, Gibala MJ. Is high-intensity interval training a time-efficient exercise strategy to improve health and fitness? Appl Physiol Nutr Metab. 2014 Mar;39(3):409-12. doi: 10.1139/apnm-2013-0187. Epub 2013 Sep 27.

  PMID: 24552392 BACKGROUND

• Hamer M, Stamatakis E, Saxton JM. The impact of physical activity on all-cause mortality in men and women after a cancer diagnosis. Cancer Causes Control. 2009 Mar;20(2):225-31. doi: 10.1007/s10552-008-9237-3. Epub 2008 Oct 2.

  PMID: 18830799 BACKGROUND

• Hvid T, Winding K, Rinnov A, Dejgaard T, Thomsen C, Iversen P, Brasso K, Mikines KJ, van Hall G, Lindegaard B, Solomon TP, Pedersen BK. Endurance training improves insulin sensitivity and body composition in prostate cancer patients treated with androgen deprivation therapy. Endocr Relat Cancer. 2013 Aug 19;20(5):621-32. doi: 10.1530/ERC-12-0393. Print 2013 Oct.

  PMID: 23744766 BACKGROUND

• Lakoski SG, Willis BL, Barlow CE, Leonard D, Gao A, Radford NB, Farrell SW, Douglas PS, Berry JD, DeFina LF, Jones LW. Midlife Cardiorespiratory Fitness, Incident Cancer, and Survival After Cancer in Men: The Cooper Center Longitudinal Study. JAMA Oncol. 2015 May;1(2):231-7. doi: 10.1001/jamaoncol.2015.0226.

  PMID: 26181028 BACKGROUND

• Laukkanen JA, Rauramaa R, Makikallio TH, Toriola AT, Kurl S. Intensity of leisure-time physical activity and cancer mortality in men. Br J Sports Med. 2011 Feb;45(2):125-9. doi: 10.1136/bjsm.2008.056713. Epub 2009 Jul 28.

  PMID: 19656766 BACKGROUND

• Mann T, Lamberts RP, Lambert MI. Methods of prescribing relative exercise intensity: physiological and practical considerations. Sports Med. 2013 Jul;43(7):613-25. doi: 10.1007/s40279-013-0045-x.

  PMID: 23620244 BACKGROUND

• Martin E, Battaglini C, Hands B, Naumann FL. Higher-intensity exercise helps cancer survivors remain motivated. J Cancer Surviv. 2016 Jun;10(3):524-33. doi: 10.1007/s11764-015-0498-z. Epub 2015 Nov 19.

  PMID: 26586495 BACKGROUND

• Martin EA, Battaglini CL, Hands B, Naumann F. Higher-Intensity Exercise Results in More Sustainable Improvements for VO2peak for Breast and Prostate Cancer Survivors. Oncol Nurs Forum. 2015 May;42(3):241-9. doi: 10.1188/15.ONF.42-03AP.

  PMID: 25901376 BACKGROUND

• Metcalfe RS, Babraj JA, Fawkner SG, Vollaard NB. Towards the minimal amount of exercise for improving metabolic health: beneficial effects of reduced-exertion high-intensity interval training. Eur J Appl Physiol. 2012 Jul;112(7):2767-75. doi: 10.1007/s00421-011-2254-z. Epub 2011 Nov 29.

  PMID: 22124524 BACKGROUND

• Metcalfe RS, Koumanov F, Ruffino JS, Stokes KA, Holman GD, Thompson D, Vollaard NB. Physiological and molecular responses to an acute bout of reduced-exertion high-intensity interval training (REHIT). Eur J Appl Physiol. 2015 Nov;115(11):2321-34. doi: 10.1007/s00421-015-3217-6. Epub 2015 Jul 9.

  PMID: 26156806 BACKGROUND

• Nguyen PL, Alibhai SM, Basaria S, D'Amico AV, Kantoff PW, Keating NL, Penson DF, Rosario DJ, Tombal B, Smith MR. Adverse effects of androgen deprivation therapy and strategies to mitigate them. Eur Urol. 2015 May;67(5):825-36. doi: 10.1016/j.eururo.2014.07.010. Epub 2014 Aug 2.

  PMID: 25097095 BACKGROUND

• Quist M, Rorth M, Zacho M, Andersen C, Moeller T, Midtgaard J, Adamsen L. High-intensity resistance and cardiovascular training improve physical capacity in cancer patients undergoing chemotherapy. Scand J Med Sci Sports. 2006 Oct;16(5):349-57. doi: 10.1111/j.1600-0838.2005.00503.x.

  PMID: 16978255 BACKGROUND

• Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

  PMID: 20559064 BACKGROUND

• Soerjomataram I, Lortet-Tieulent J, Parkin DM, Ferlay J, Mathers C, Forman D, Bray F. Global burden of cancer in 2008: a systematic analysis of disability-adjusted life-years in 12 world regions. Lancet. 2012 Nov 24;380(9856):1840-50. doi: 10.1016/S0140-6736(12)60919-2. Epub 2012 Oct 16.

  PMID: 23079588 BACKGROUND

• Toohey K, Pumpa KL, Arnolda L, Cooke J, Yip D, Craft PS, Semple S. A pilot study examining the effects of low-volume high-intensity interval training and continuous low to moderate intensity training on quality of life, functional capacity and cardiovascular risk factors in cancer survivors. PeerJ. 2016 Oct 20;4:e2613. doi: 10.7717/peerj.2613. eCollection 2016.

  PMID: 27781180 BACKGROUND

• Wang KL, Cheng HM, Sung SH, Chuang SY, Li CH, Spurgeon HA, Ting CT, Najjar SS, Lakatta EG, Yin FC, Chou P, Chen CH. Wave reflection and arterial stiffness in the prediction of 15-year all-cause and cardiovascular mortalities: a community-based study. Hypertension. 2010 Mar;55(3):799-805. doi: 10.1161/HYPERTENSIONAHA.109.139964. Epub 2010 Jan 11.

  PMID: 20065155 BACKGROUND

• 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

  BACKGROUND

• Weston M, Taylor KL, Batterham AM, Hopkins WG. Effects of low-volume high-intensity interval training (HIT) on fitness in adults: a meta-analysis of controlled and non-controlled trials. Sports Med. 2014 Jul;44(7):1005-17. doi: 10.1007/s40279-014-0180-z.

  PMID: 24743927 BACKGROUND

• Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/

  PMID: 26180873 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• James Turner, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Lecturer in Human Physiology

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 13, 2017
• Study Start: May 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)