NCT03097224

Brief Summary

Objectives To investigate the impact of tele-supervised prehabilitation on functional capacity in frail colon cancer patients undergoing colorectal resection 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 (PREHAB) or a control group. Prehabilitation group will participate in a 4-week telerehabilitation before surgery while the control group will receive usual care and World Health Organization recommendations on physical activity for health before surgery. Program exercise will consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will have assessments at baseline, pre-intervention and 8 weeks after surgery. The primary outcome will be functional capacity measured by using the 6-min walk test. The secondary outcomes will be: physical measurements, QoL, level of physical activity, executive functions, fatigue, body composition, blood test, energy expenditure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

March 17, 2017

Last Update Submit

September 17, 2019

Conditions

Colon CancerFragility

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 and 8 weeks after the surgery

Secondary Outcomes (17)

  • Change in muscle strength

    Assessments at baseline, one day before the surgery and 8 weeks after the surgery

  • Change in muscle endurance

    Assessments at baseline, one day before the surgery and 8 weeks after the surgery

  • Change in quality of life

    Assessments at baseline, one day before the surgery and 8 weeks after the surgery

  • Change in fatigue

    Assessments at baseline, one day before the surgery and 8 weeks after the surgery

  • Change in level of physical activity

    Assessments at baseline, one day before the surgery and 8 weeks after the surgery

  • +12 more secondary outcomes

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

Tele-supervised prehabilitation

Behavioral: Prehabilitation

Control group

NO INTERVENTION

Usual care

Interventions

PrehabilitationBEHAVIORAL

Four weeks of tele-supervised prehabilitation

Prehabilitation group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of colon cancer requiring surgery
  • More than 65 years of age;
  • Able to read, write and understand French;
  • Frailty phenotype criteria ≥ 3

You may not qualify if:

  • The participants have a physical impairment that would seriously impair physical mobility;
  • the surgery is an emergency;
  • The participants have a neuropsychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Woluwé-Saint-Lambert, 1200, Belgium

RECRUITING

Related Publications (14)

  • 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: 26614304BACKGROUND

  • 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: 23485231BACKGROUND

  • 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: 19944536BACKGROUND

  • 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: 15501119BACKGROUND

  • 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: 20573634BACKGROUND

  • 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: 23880071BACKGROUND

  • Millan M, Merino S, Caro A, Feliu F, Escuder J, Francesch T. Treatment of colorectal cancer in the elderly. World J Gastrointest Oncol. 2015 Oct 15;7(10):204-20. doi: 10.4251/wjgo.v7.i10.204.

    PMID: 26483875BACKGROUND

  • Handforth C, Clegg A, Young C, Simpkins S, Seymour MT, Selby PJ, Young J. The prevalence and outcomes of frailty in older cancer patients: a systematic review. Ann Oncol. 2015 Jun;26(6):1091-1101. doi: 10.1093/annonc/mdu540. Epub 2014 Nov 17.

    PMID: 25403592BACKGROUND

  • Chen X, Mao G, Leng SX. Frailty syndrome: an overview. Clin Interv Aging. 2014 Mar 19;9:433-41. doi: 10.2147/CIA.S45300. eCollection 2014.

    PMID: 24672230BACKGROUND

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND

  • Fagard K, Leonard S, Deschodt M, Devriendt E, Wolthuis A, Prenen H, Flamaing J, Milisen K, Wildiers H, Kenis C. The impact of frailty on postoperative outcomes in individuals aged 65 and over undergoing elective surgery for colorectal cancer: A systematic review. J Geriatr Oncol. 2016 Nov;7(6):479-491. doi: 10.1016/j.jgo.2016.06.001. Epub 2016 Jun 21.

    PMID: 27338516BACKGROUND

  • 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: 24440732BACKGROUND

  • 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: 37162250DERIVED

  • 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: 35588252DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Gilles Caty, PhD

CONTACT

+3227641650gilles.caty@uclouvain.be

Elise Piraux, PhD student

CONTACT

+3227645375elise.piraux@uclouvain.be

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 31, 2017

Study Start

April 4, 2017

Primary Completion

April 1, 2020

Study Completion

July 1, 2020

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

BE(1)