Prehabilitation in Colorectal Cancer

NCT03096951 | Completed

• 1 other identifier: Part 1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives To investigate the impact of tele-supervised prehabilitation on functional capacity in colon cancer patients undergoing colorectal resection for cancer and to evaluate the effects of prehabilitation on muscle strength and endurance, quality of life (QoL), executive functions, fatigue and inflammatory and metabolic parameters. Methods A randomized controlled trial will be conducted. Patients will be randomised into either a prehabilitation group or a control group. The prehabilitation group will receive tele-supervised prehabilitation for 4weeks and telerehabilitation for 8weeks post-surgery while control group will begin telerehabilitation only after surgery for 8weeks. Patients will care with an enhanced recovery pathway. Telerehabilitation pre and post-surgery will consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will be assessed at baseline, pre-intervention, post-intervention and post-rehabilitation. The primary outcome will be functional capacity measured using the 6-min walk test. The secondary outcomes will be: physical measurement, quality of life, level of physical activity, executive functions, fatigue, body composition, blood test, energy expenditure.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Change in cardiorespiratory fitness

  Cardiorespiratory is measured by a 6-minute walk test

  Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation

Secondary Outcomes (17)

• Change in muscle strength

  Assessments at baseline, one day before the surgery, immediately after the rehabilitation

• Change in muscle endurance

  Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation

• Change in quality of life

  Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation

• Change in fatigue

  Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation

• Change in level of physical activity

  Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

Preoperative and postoperative telerehabilitation

Behavioral: Prehabilitation

Rehabilitation group

ACTIVE COMPARATOR

Postoperative telerehabilitation

Other: Rehabilitation

Interventions

Prehabilitation BEHAVIORAL

Prehabilitation group will receive a 4-week tele-supervised prehabilitation and a 8-week tele-supervised postoperative rehabilitation.

Prehabilitation group

Rehabilitation OTHER

Rehabilitation group will receive World Health Organization recommendations on physical activity for health before surgery and a 8-week tele-supervised postoperative rehabilitation.

Rehabilitation group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of colon cancer requiring surgery;
• more than 40 years of age;
• autonomous and voluntary person;
• able to read, write and understand French;
• Frailty phenotype criteria \< 3

You may not qualify if:

• a physical impairment that would seriously impair physical mobility;
• an unfavorable familial context;
• a stoma;
• American Society of Anesthesiologists score IV-V;
• emergency;
• neuropsychiatric disease.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Woluwé-Saint-Lambert, 1200, Belgium

Location

Related Publications (14)

• Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

  PMID: 23485231 BACKGROUND

• Boereboom C, Doleman B, Lund JN, Williams JP. Systematic review of pre-operative exercise in colorectal cancer patients. Tech Coloproctol. 2016 Feb;20(2):81-9. doi: 10.1007/s10151-015-1407-1. Epub 2015 Nov 27.

  PMID: 26614304 BACKGROUND

• Pallis AG, Papamichael D, Audisio R, Peeters M, Folprecht G, Lacombe D, Van Cutsem E. EORTC Elderly Task Force experts' opinion for the treatment of colon cancer in older patients. Cancer Treat Rev. 2010 Feb;36(1):83-90. doi: 10.1016/j.ctrv.2009.10.008. Epub 2009 Nov 26.

  PMID: 19944536 BACKGROUND

• Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394.

  PMID: 24469618 BACKGROUND

• Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.

  PMID: 15896435 BACKGROUND

• Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23.

  PMID: 20573634 BACKGROUND

• Robinson TN, Wu DS, Pointer L, Dunn CL, Cleveland JC Jr, Moss M. Simple frailty score predicts postoperative complications across surgical specialties. Am J Surg. 2013 Oct;206(4):544-50. doi: 10.1016/j.amjsurg.2013.03.012. Epub 2013 Jul 20.

  PMID: 23880071 BACKGROUND

• Lawrence VA, Hazuda HP, Cornell JE, Pederson T, Bradshaw PT, Mulrow CD, Page CP. Functional independence after major abdominal surgery in the elderly. J Am Coll Surg. 2004 Nov;199(5):762-72. doi: 10.1016/j.jamcollsurg.2004.05.280.

  PMID: 15501119 BACKGROUND

• West MA, Lythgoe D, Barben CP, Noble L, Kemp GJ, Jack S, Grocott MP. Cardiopulmonary exercise variables are associated with postoperative morbidity after major colonic surgery: a prospective blinded observational study. Br J Anaesth. 2014 Apr;112(4):665-71. doi: 10.1093/bja/aet408. Epub 2013 Dec 8.

  PMID: 24322573 BACKGROUND

• Debes C, Aissou M, Beaussier M. [Prehabilitation. Preparing patients for surgery to improve functional recovery and reduce postoperative morbidity]. Ann Fr Anesth Reanim. 2014 Jan;33(1):33-40. doi: 10.1016/j.annfar.2013.12.012. Epub 2014 Jan 17. French.

  PMID: 24440732 BACKGROUND

• Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.

  PMID: 21328298 BACKGROUND

• Cooper RA, Fitzgerald SG, Boninger ML, Brienza DM, Shapcott N, Cooper R, et al. Telerehabilitation: Expanding access to rehabilitation expertise. Proceedings of the IEEE. 2001;89(8):1174-93.

  BACKGROUND

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.

  PMID: 37162250 DERIVED

• Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.

  PMID: 35588252 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Preoperative Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 30, 2017
• Study Start: April 4, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

BE (1)