Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol

Sherman G Wong, Eugene Maida, David Harvey, Natalie Wagner, Ranil Sonnadara, Nalin Amin, Sherman G Wong, Eugene Maida, David Harvey, Natalie Wagner, Ranil Sonnadara, Nalin Amin

Abstract

Introduction: Prehabilitation interventions have shown efficacy in the orthopaedic and cardiothoracic surgical populations, but there has been limited evidence for general surgical patients. We present the protocol for a pilot trial of a novel prehabilitation intervention, consisting of a physiatrist-directed preoperative assessment and treatment programme.

Methods and analysis: This is a single-centre pilot randomised controlled trial investigating physiatrist-directed prehabilitation for a 4 to 6-week preoperative period. We will block randomise 40-50 participants awaiting surgery for colorectal cancer to prehabilitation versus control. Participants in the prehabilitation arm will undergo assessment by a physiatrist and enrol in a supervised exercise programme. The control group will not undergo any prehabilitation interventions in the preoperative period. Our primary outcome is feasibility, measured by examining recruitment, refusal, retention and adherence rates as well as participant satisfaction and feedback. Secondary outcomes include physical fitness, functional ability, health-related quality of life, postoperative complications, mortality, readmissions, length of stay, prehabilitation interventions performed and exercise complications.

Ethics and dissemination: This study has been approved by the Hamilton Integrated Research Ethics Board (HIREB reference number 2015-0090-GRA). The results of this pilot study will be used to design a full-scale study and published in peer-reviewed journals.

Trial registration number: NCT02531620; Pre-results.

Keywords: Adult surgery; Colorectal surgery; Prehabilitation; REHABILITATION MEDICINE; SURGERY.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study participant flow chart.

References

    1. Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care 2005;8:23–32. 10.1097/00075197-200501000-00005
    1. Carli F, Scheede-Bergdahl C. Prehabilitation to enhance perioperative care. Anesthesiol Clin 2015;33:17–33. 10.1016/j.anclin.2014.11.002
    1. Hulzebos EH, Smit Y, Helders PP, et al. . The Cochrane Collaboration Preoperative physical therapy for elective cardiac surgery patients : Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd, 2012. (accessed 29 Aug 2016).
    1. Morano MT, Araújo AS, Nascimento FB, et al. . Preoperative pulmonary rehabilitation versus chest physical therapy in patients undergoing lung Cancer resection: a pilot randomized controlled trial. Arch Phys Med Rehabil 2013;94:53–8. 10.1016/j.apmr.2012.08.206
    1. Benzo R, Wigle D, Novotny P, et al. . Preoperative pulmonary rehabilitation before lung Cancer resection: results from two randomized studies. Lung Cancer 2011;74:441–5. 10.1016/j.lungcan.2011.05.011
    1. Gill SD, McBurney H. Does exercise reduce pain and improve physical function before hip or knee replacement surgery? A systematic review and meta-analysis of randomized controlled trials. Arch Phys Med Rehabil 2013;94:164–76. 10.1016/j.apmr.2012.08.211
    1. Gillis C, Li C, Lee L, et al. . Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for Cancer. Anesthesiology 2014;121:937–47. 10.1097/ALN.0000000000000393
    1. Li C, Carli F, Lee L, et al. . Impact of a trimodal prehabilitation program on functional recovery after colorectal Cancer surgery: a pilot study. Surg Endosc 2013;27:1072–82. 10.1007/s00464-012-2560-5
    1. Dronkers JJ, Lamberts H, Reutelingsperger IM, et al. . Preoperative therapeutic programme for elderly patients scheduled for elective abdominal oncological surgery: a randomized controlled pilot study. Clin Rehabil 2010;24:614–22. 10.1177/0269215509358941
    1. Debette-Gratien M, Tabouret T, Antonini MT, et al. . Personalized adapted physical activity before liver transplantation: acceptability and results. Transplantation 2015;99:145–50. 10.1097/TP.0000000000000245
    1. Dunne DF, Jack S, Jones RP, et al. . Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg 2016;103:504–12. 10.1002/bjs.10096
    1. Soares SM, Nucci LB, da Silva MM, et al. . Pulmonary function and physical performance outcomes with preoperative physical therapy in upper abdominal surgery: a randomized controlled trial. Clin Rehabil 2013;27:616–27. 10.1177/0269215512471063
    1. Baillot A, Mampuya WM, Comeau E, et al. . Feasibility and impacts of supervised exercise training in subjects with obesity awaiting bariatric surgery: a pilot study. Obes Surg 2013;23:882–91. 10.1007/s11695-013-0875-5
    1. Kaibori M, Ishizaki M, Matsui K, et al. . Perioperative exercise for chronic liver injury patients with hepatocellular carcinoma undergoing hepatectomy. Am J Surg 2013;206:202–9. 10.1016/j.amjsurg.2012.07.035
    1. Barbalho-Moulim MC, Miguel GP, Forti EM, et al. . Effects of preoperative inspiratory muscle training in obese women undergoing open bariatric surgery: respiratory muscle strength, lung volumes, and diaphragmatic excursion. Clinics 2011;66:1721–7. 10.1590/S1807-59322011001000009
    1. Cho H, Yoshikawa T, Oba MS, et al. . Matched pair analysis to examine the effects of a planned preoperative exercise program in early gastric Cancer patients with metabolic syndrome to reduce operative risk: the adjuvant exercise for General Elective Surgery (AEGES) study group. Ann Surg Oncol 2014;21:2044–50. 10.1245/s10434-013-3394-7
    1. Moran J, Guinan E, McCormick P, et al. . The ability of prehabilitation to influence postoperative outcome after intra-abdominal operation: a systematic review and meta-analysis. Surgery 2016;160:1189–201. 10.1016/j.surg.2016.05.014
    1. Santa Mina D, Clarke H, Ritvo P, et al. . Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy 2014;100:196–207. 10.1016/j.physio.2013.08.008
    1. Timmerman H, de Groot JF, Hulzebos HJ, et al. . Feasibility and preliminary effectiveness of preoperative therapeutic exercise in patients with Cancer: a pragmatic study. Physiother Theory Pract 2011;27:117–24. 10.3109/09593981003761509
    1. Carli F, Charlebois P, Stein B, et al. . Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg 2010;97:1187–97. 10.1002/bjs.7102
    1. Fried LP, Tangen CM, Walston J, et al. . Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001;56:M146–M157. 10.1093/gerona/56.3.M146
    1. Cheifetz O, Park Dorsay J, Hladysh G, et al. . CanWell: meeting the psychosocial and exercise needs of Cancer survivors by translating evidence into practice. Psychooncology 2014;23:204–15. 10.1002/pon.3389
    1. Obeid JS, McGraw CA, Minor BL, et al. . Procurement of shared data instruments for Research Electronic Data Capture (REDCap). J Biomed Inform 2013;46:259–65. 10.1016/j.jbi.2012.10.006
    1. Lehmann JF, DeLisa JA, Warren CG, et al. . Cancer rehabilitation: assessment of need, development, and evaluation of a model of care. Arch Phys Med Rehabil 1978;59:410–9.
    1. Attkisson CC, Greenfield TK. The UCSF Client satisfaction scales: I. The Client satisfaction Questionnaire-8. (accessed 6 Mar 2017).
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111 10.1164/ajrccm.166.1.at1102
    1. Turner-Stokes L, Nyein K, Turner-Stokes T, et al. . The UK FIM+FAM: development and evaluation. Clin Rehabil 1999;13:277–87. 10.1191/026921599676896799
    1. Bruera E, Kuehn N, Miller MJ, et al. . The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care 1991;7:6–9.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.
    1. Carlsson AM. Assessment of chronic pain. I. aspects of the reliability and validity of the visual analogue scale. Pain 1983;16:87–101. 10.1016/0304-3959(83)90088-X
    1. Ducrotté P, Caussé C. The bowel function index: a new validated scale for assessing opioid-induced constipation. Curr Med Res Opin 2012;28:457–66. 10.1185/03007995.2012.657301
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13.
    1. National Cancer Institute. Common Terminology Criteria for adverse events v4.0. 2009. (accessed 1 Mar 2017).
    1. Burke SM, Brunet J, Sabiston CM, et al. . Patients' perceptions of quality of life during active treatment for locally advanced rectal Cancer: the importance of preoperative exercise. Support Care Cancer 2013;21:3345–53. 10.1007/s00520-013-1908-2
    1. Kim DJ, Mayo NE, Carli F, et al. . Responsive measures to prehabilitation in patients undergoing bowel resection surgery. Tohoku J Exp Med 2009;217:109–15. 10.1620/tjem.217.109
    1. West MA, Loughney L, Lythgoe D, et al. . Effect of prehabilitation on objectively measured physical fitness after neoadjuvant treatment in preoperative rectal Cancer patients: a blinded interventional pilot study. Br J Anaesth 2015;114:244–51. 10.1093/bja/aeu318
    1. Dronkers J, Veldman A, Hoberg E, et al. . Prevention of pulmonary complications after upper abdominal surgery by preoperative intensive inspiratory muscle training: a randomized controlled pilot study. Clin Rehabil 2008;22:134–42. 10.1177/0269215507081574
    1. Kulkarni SR, Fletcher E, McConnell AK, et al. . Pre-operative inspiratory muscle training preserves postoperative inspiratory muscle strength following Major abdominal surgery - a randomised pilot study. Ann R Coll Surg Engl 2010;92:700–5. 10.1308/003588410X12771863936648

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