Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the ‘FC Prostate’ randomized controlled trial

BMC Cancer

Jacob Uth⁴  Jakob Friis Schmidt²  Jesper Frank Christensen⁴  Therese Hornstrup²  Lars Juel Andersen⁷  Peter Riis Hansen³  Karl Bang Christensen⁶  Lars Louis Andersen⁹  Eva Wulff Helge²  Klaus Brasso⁸  Mikael Rørth¹  Peter Krustrup⁵  Julie Midtgaard¹⁰ 

[1] Department of Oncology, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

[2] Department of Nutrition, Exercise and Sports, University of Copenhagen, Nørre Allé 51, Copenhagen 2200, Denmark

[3] Department of Cardiology, Copenhagen University Hospital Gentofte Hospital, Niels Andersens Vej 65, Hellerup 2900, Denmark

[4] The University Hospitals Centre for Health Care Research (UCSF), Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, Copenhagen 2100, Denmark

[5] Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter, Prince of Wales Road, Exeter, Devon, UK

[6] Department of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, Copenhagen 1014, Denmark

[7] Department of Cardiology, Herlev University Hospital, Herlev Ringvej 75, Herlev 2730, Denmark

[8] Department of Urology and Copenhagen Prostate Cancer Center, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, Copenhagen 2100, Denmark

[9] The National Research Centre for the Working Environment, Lersø Parkallé 105, Copenhagen 2100, Denmark

[10] Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, Copenhagen 2200, Denmark

关键词: Cardiovascular function;    Body composition;    Rehabilitation;    Soccer training;    Physical exercise;    Androgen deprivation therapy;    Prostate cancer;   

Others  :  859197
DOI  :  10.1186/1471-2407-13-595

 received in 2013-09-19, accepted in 2013-12-06,  发布年份 2013

【 摘 要 】

Background

Androgen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted. The ‘Football Club (FC) Prostate’ study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer.

Methods/Design

Using a single-center randomized controlled design, 80 men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for 6 months or more at The Copenhagen University Hospital will be enrolled on this trial. After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care. The soccer intervention will consist of 12 weeks of training 2–3 times/week for 45–60 min after which the assessment protocol will be repeated. Soccer training will then continue bi-weekly for an additional 20 weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects. The primary endpoint is changes in lean body mass from baseline to 12 weeks assessed by dual X-ray absorptiometry scan. Secondary endpoints include changes of cardiovascular, metabolic, and physical function parameters, as well as markers of bone metabolism and patient-reported outcomes.

Discussion

The FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT. The results may pave the way for innovative, community-based interventions in the approach to treating prostate cancer.

Trial registration

ClinicalTrials.gov: NCT01711892

【 授权许可】

   
2013 Uth et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D: Global cancer statistics. CA Cancer J Clin 2011, 61:69-90.
• [2]Meng MV, Grossfeld GD, Sadetsky N, Mehta SS, Lubeck DP, Carroll PR: Contemporary patterns of androgen deprivation therapy use for newly diagnosed prostate cancer. Urology 2002, 60(3 Suppl 1):7-11. discussion 11–12
• [3]Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh ACM, Oddens J, Poortmans PMP, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L, EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group: Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med 2009, 360:2516-2527.
• [4]Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Schmid H-P, Van der Kwast T, Wiegel T, Zattoni F, Heidenreich A: EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2011, 59:572-583.
• [5]Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E: Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin 2012, 62:220-241.
• [6]Galvão DA, Spry NA, Taaffe DR, Newton RU, Stanley J, Shannon T, Rowling C, Prince R: Changes in muscle, fat and bone mass after 36 weeks of maximal androgen blockade for prostate cancer. BJU Int 2008, 102:44-47.
• [7]Galvao DA, Taaffe DR, Spry N, Joseph D, Turner D, Newton RU: Reduced muscle strength and functional performance in men with prostate cancer undergoing androgen suppression: a comprehensive cross-sectional investigation. Prostate Cancer Prostatic Dis 2008, 12:198-203.
• [8]Bylow K, Dale W, Mustian K, Stadler WM, Rodin M, Hall W, Lachs M, Mohile SG: Falls and physical performance deficits in older patients with prostate cancer undergoing androgen deprivation therapy. Urology 2008, 72:422-427.
• [9]Abrahamsen B, Nielsen MF, Eskildsen P, Andersen JT, Walter S, Brixen K: Fracture risk in Danish men with prostate cancer: a nationwide register study. BJU Int 2007, 100:749-754.
• [10]Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S: Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol Off J Am Soc Clin Oncol 2006, 24:3979-3983.
• [11]Keating NL, O’Malley AJ, Smith MR: Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol Off J Am Soc Clin Oncol 2006, 24:4448-4456.
• [12]Levine GN, D’Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N: Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. CA Cancer J Clin 2010, 60:194-201.
• [13]Wolin KY, Schwartz AL, Matthews CE, Courneya KS, Schmitz KH: Implementing the exercise guidelines for cancer survivors. J Support Oncol 2012, 10:171-177.
• [14]Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão 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, 42:1409-1426.
• [15]Galvão DA, Taaffe DR, Spry N, Joseph D, Newton RU: Combined resistance and aerobic exercise program reverses muscle loss in men undergoing androgen suppression therapy for prostate cancer without bone metastases: a randomized controlled trial. J Clin Oncol Off J Am Soc Clin Oncol 2010, 28:340-347.
• [16]Segal RJ, Reid RD, Courneya KS, Sigal RJ, Kenny GP, Prud’Homme DG, Malone SC, Wells GA, Scott CG, Slovinec D’Angelo ME: Randomized controlled trial of resistance or aerobic exercise in men receiving radiation therapy for prostate cancer. J Clin Oncol Off J Am Soc Clin Oncol 2009, 27:344-351.
• [17]Culos-Reed SN, Robinson JW, Lau H, Stephenson L, Keats M, Norris S, Kline G, Faris P: Physical activity for men receiving androgen deprivation therapy for prostate cancer: benefits from a 16-week intervention. Support Care Cancer Off J Multinatl Assoc Support Care Cancer 2010, 18:591-599.
• [18]Santa Mina D, Alibhai SMH, Matthew AG, Guglietti CL, Pirbaglou M, Trachtenberg J, Ritvo P: A Randomized Trial of Aerobic Versus Resistance Exercise in Prostate Cancer Survivors. J Aging Phys Act 2013, 21:455-478.
• [19]Segal RJ, Reid RD, Courneya KS, Malone SC, Parliament MB, Scott CG, Venner PM, Quinney HA, Jones LW, D’Angelo MES, Wells GA: Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol Off J Am Soc Clin Oncol 2003, 21:1653-1659.
• [20]Price GM, Uauy R, Breeze E, Bulpitt CJ, Fletcher AE: Weight, shape, and mortality risk in older persons: elevated waist-hip ratio, not high body mass index, is associated with a greater risk of death. Am J Clin Nutr 2006, 84:449-460.
• [21]Rowland TW: Children’s Exercise Physiology. 2nd edition. Leeds: Human Kinetics; 2005.
• [22]Deforche B, Lefevre J, De Bourdeaudhuij I, Hills AP, Duquet W, Bouckaert J: Physical fitness and physical activity in obese and nonobese Flemish youth. Obes Res 2003, 11:434-441.
• [23]Winter D: Biomechanics and Motor Control of Human Movement. 2nd edition. New York: Wiley; 1990.
• [24]Jakobsen MD, Sundstrup E, Krustrup P, Aagaard P: The effect of recreational soccer training and running on postural balance in untrained men. Eur J Appl Physiol 2011, 111:521-530.
• [25]Jay K, Jakobsen MD, Sundstrup E, Skotte JH, Jørgensen MB, Andersen CH, Pedersen MT, Andersen LL: Effects of kettlebell training on postural coordination and jump performance: a randomized controlled trial. J Strength Cond Res Natl Strength Cond Assoc 2013, 27:1202-1209.
• [26]Jones CJ, Rikli RE, Beam WC: A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport 1999, 70:113-119.
• [27]Skelton DA, Young A, Greig CA, Malbut KE: Effects of resistance training on strength, power, and selected functional abilities of women aged 75 and older. J Am Geriatr Soc 1995, 43:1081-1087.
• [28]Taaffe DR, Duret C, Wheeler S, Marcus R: Once-weekly resistance exercise improves muscle strength and neuromuscular performance in older adults. J Am Geriatr Soc 1999, 47:1208-1214.
• [29]Schmidt JF, Andersen TR, Horton J, Brix J, Tarnow L, Krustrup P, Andersen LJ, Bangsbo J, Hansen PR: Soccer Training Improves Cardiac Function in Men with Type 2 Diabetes. Med Sci Sports Exerc 2013, 45:2223-2233.
• [30]Søgaard P, Egeblad H, Kim WY, Jensen HK, Pedersen AK, Kristensen BØ, Mortensen PT: Tissue doppler imaging predicts improved systolic performance and reversed left ventricular remodeling during long-term cardiac resynchronization therapy. J Am Coll Cardiol 2002, 40:723-730.
• [31]Celermajer DS: Reliable endothelial function testing: at our fingertips? Circulation 2008, 117:2428-2430.
• [32]Matsuda M, DeFronzo RA: Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care 1999, 22:1462-1470.
• [33]Carlsen K, Dalton SO, Diderichsen F, Johansen C: Risk for unemployment of cancer survivors: a Danish cohort study. Eur J Cancer 2008, 44:1866-1874.
• [34]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483.
• [35]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC: The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
• [36]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370.
• [37]Bjelland I, Dahl AA, Haug TT, Neckelmann D: The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002, 52:69-77.
• [38]Dahlem NW, Zimet GD, Walker RR: The multidimensional scale of perceived social support: a confirmation study. J Clin Psychol 1991, 47:756-761.
• [39]Aadahl M, Jørgensen T: Validation of a new self-report instrument for measuring physical activity. Med Sci Sports Exerc 2003, 35:1196-1202.
• [40]Elbe A-M, Strahler K, Krustrup P, Wikman J, Stelter R: Experiencing flow in different types of physical activity intervention programs: three randomized studies. Scand J Med Sci Sports 2010, 20:111-117.
• [41]Krustrup P, Christensen JF, Randers MB, Pedersen H, Sundstrup E, Jakobsen MD, Krustrup BR, Nielsen JJ, Suetta C, Nybo L, Bangsbo J: Muscle adaptations and performance enhancements of soccer training for untrained men. Eur J Appl Physiol 2010, 108:1247-1258.
• [42]Andersen JL, Aagaard P: Myosin heavy chain IIX overshoot in human skeletal muscle. Muscle Nerve 2000, 23:1095-1104.
• [43]Shahinian VB, Kuo Y-F, Freeman JL, Goodwin JS: Risk of fracture after androgen deprivation for prostate cancer. N Engl J Med 2005, 352:154-164.
• [44]Alibhai SMH, Breunis H, Timilshina N, Johnston C, Tomlinson G, Tannock I, Krahn M, Fleshner NE, Warde P, Canning SD, Klotz L, Naglie G: Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer. J Clin Oncol Off J Am Soc Clin Oncol 2010, 28:5038-5045.
• [45]Hydock DS, Wonders KY, Schneider CM, Hayward R: Androgen deprivation therapy and cardiac function: effects of endurance training. Prostate Cancer Prostatic Dis 2006, 9:392-398.
• [46]Khan KM, Thompson AM, Blair SN, Sallis JF, Powell KE, Bull FC, Bauman AE: Sport and exercise as contributors to the health of nations. Lancet 2012, 380:59-64.
• [47]Sabia S, Dugravot A, Kivimaki M, Brunner E, Shipley MJ, Singh-Manoux A: Effect of intensity and type of physical activity on mortality: results from the Whitehall II cohort study. Am J Public Health 2012, 102:698-704.
• [48]FIFA Big Count 2006: 270 million people active in football - FIFA.com http://www.fifa.com/aboutfifa/organisation/media/news/newsid=529882/index.html webcite
• [49]Krustrup P, Nielsen JJ, Krustrup BR, Christensen JF, Pedersen H, Randers MB, Aagaard P, Petersen A-M, Nybo L, Bangsbo J: Recreational Soccer Is an Effective Health-Promoting Activity for Untrained Men. Br J Sports Med 2009, 43:825-831.
• [50]Krustrup P, Randers MB, Andersen LJ, Jackman SR, Bangsbo J, Hansen PR: Soccer improves fitness and attenuates cardiovascular risk factors in hypertensive men. Med Sci Sports Exerc 2013, 45:553-560.
• [51]Andersen LJ, Randers MB, Westh K, Martone D, Hansen PR, Junge A, Dvorak J, Bangsbo J, Krustrup P: Football as a treatment for hypertension in untrained 30–55-year-old men: a prospective randomized study. Scand J Med Sci Sports 2010, 20:98-102.
• [52]Helge EW, Aagaard P, Jakobsen MD, Sundstrup E, Randers MB, Karlsson MK, Krustrup P: Recreational football training decreases risk factors for bone fractures in untrained premenopausal women. Scand J Med Sci Sports 2010, 20:31-39.
• [53]Randers MB, Nielsen JJ, Krustrup BR, Sundstrup E, Jakobsen MD, Nybo L, Dvorak J, Bangsbo J, Krustrup P: Positive performance and health effects of a football training program over 12 weeks can be maintained over a 1-year period with reduced training frequency. Scand J Med Sci Sports 2010, 20(Suppl 1):80-89.
• [54]Krustrup P, Hansen PR, Andersen LJ, Jakobsen MD, Sundstrup E, Randers MB, Christiansen L, Helge EW, Pedersen MT, Søgaard P, Junge A, Dvorak J, Aagaard P, Bangsbo J: Long-term musculoskeletal and cardiac health effects of recreational football and running for premenopausal women. Scand J Med Sci Sports 2010, 20:58-71.
• [55]Pedersen MT, Randers MB, Skotte JH, Krustrup P: Recreational soccer can improve the reflex response to sudden trunk loading among untrained women. J Strength Cond Res Natl Strength Cond Assoc 2009, 23:2621-2626.
• [56]Randers MB, Nybo L, Petersen J, Nielsen JJ, Christiansen L, Bendiksen M, Brito J, Bangsbo J, Krustrup P: Activity profile and physiological response to football training for untrained males and females, elderly and youngsters: influence of the number of players. Scand J Med Sci Sports 2010, 20:14-23.
• [57]Jackman SR, Scott S, Randers MB, Orntoft C, Blackwell J, Zar A, Helge EW, Mohr M, Krustrup P: Musculoskeletal health profile for elite female footballers versus untrained young women before and after 16 weeks of football training. J Sports Sci 2013, 31:1468-1474.
• [58]Turner CH, Robling AG: Designing exercise regimens to increase bone strength. Exerc Sport Sci Rev 2003, 31:45-50.
• [59]Krustrup P, Aagaard P, Nybo L, Petersen J, Mohr M, Bangsbo J: Recreational football as a health promoting activity: a topical review. Scand J Med Sci Sports 2010, 20(Suppl 1):1-13.
• [60]Krustrup P, Hansen PR, Randers MB, Nybo L, Martone D, Andersen LJ, Bune LT, Junge A, Bangsbo J: Beneficial effects of recreational football on the cardiovascular risk profile in untrained premenopausal women. Scand J Med Sci Sports 2010, 20:40-49.
• [61]Meyer T, Auracher M, Heeg K, Urhausen A, Kindermann W: Effectiveness of low-intensity endurance training. Int J Sports Med 2007, 28:33-39.
• [62]Bangsbo J, Nielsen JJ, Mohr M, Randers MB, Krustrup BR, Brito J, Nybo L, Krustrup P: Performance enhancements and muscular adaptations of a 16-week recreational football intervention for untrained women. Scand J Med Sci Sports 2010, 20:24-30.
• [63]Nybo L, Sundstrup E, Jakobsen MD, Mohr M, Hornstrup T, Simonsen L, Bülow J, Randers MB, Nielsen JJ, Aagaard P, Krustrup P: High-intensity training versus traditional exercise interventions for promoting health. Med Sci Sports Exerc 2010, 42:1951-1958.
• [64]Ottesen L, Jeppesen RS, Krustrup BR: The development of social capital through football and running: studying an intervention program for inactive women. Scand J Med Sci Sports 2010, 20:118-131.
• [65]Sundstrup E, Jakobsen MD, Andersen JL, Randers MB, Petersen J, Suetta C, Aagaard P, Krustrup P: Muscle function and postural balance in lifelong trained male footballers compared with sedentary elderly men and youngsters. Scand J Med Sci Sports 2010, 20:90-97.
• [66]Adamsen L, Rasmussen JM, Pedersen LS: “Brothers in arms”: how men with cancer experience a sense of comradeship through group intervention which combines physical activity with information relay. J Clin Nurs 2001, 10:528-537.