Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.

NCT03423056 | Unknown DMC

• 1 other identifier: C41030617-091
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures. It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention. Main objective: To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery. Materials and methods: This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle. The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence. This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board

Conditions

Stomach Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Liver Neoplasm

Keywords

Gastrointestinal Neoplasms; Exercise; Preoperative Period; Preoperative Care

Outcome Measures

Primary Outcomes (1)

• Peak oxygen comsumption

  peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation

  4 weeks after the exercise program beginning

Secondary Outcomes (3)

• exercise-related adverse events

  3 and 4 weeks after the exercise program beginning

• program adherence

  3 weeks after the exercise program beginning.

• Peak oxygen comsumption - 3 weeks

  3 weeks after the exercise program beginning

Study Arms (1)

Preoperative exercise program

EXPERIMENTAL

The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows: Week 1: heart rate target: 50% of maximum heart rate Week 2: heart rate target: 60% of maximum heart rate Week 3: heart rate target: 70% of maximum heart rate Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.

Other: Preoperative exercise program

Interventions

Preoperative exercise program OTHER

Individualized aerobic training program developed by physical therapist using Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed between 50 to 70% of the maximum heart rate and will be carried on a treadmill or in a stationary bicycle.

Also known as: Preoperative aerobic exercise short program

Preoperative exercise program

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years
• Confirmed diagnosis of gastric, hepatic, colon or rectal cancer.
• Live in Bogota for at least 3 months
• Hemoglobin concentration superior to 10g/dL
• Primary surgery date scheduled in the next 4 weeks or more since eligibility assessment
• ECOG score 0 or 1

You may not qualify if:

• Behavior or cognitive impairment
• musculoskeletal impairment
• any exercise contraindication (fracture or sprains in the last 2 months, severe osteoarthritis, tendinitis)
• Uncontrolled metabolically comorbidities (diabetes, hypertension, hyperlipidemia)
• Presence of obstructive or restrictive pulmonary disease
• Enrolled in another supervised exercise program
• Major electrocardiographic abnormalities.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead
• Universidad Nacional de Colombia: collaborator

Study Sites (1)

Instituto Nacional de Cancerología

Bogota, Cundinamarca, 0000, Colombia

RECRUITING

Related Publications (27)

• Pardo C, Cendales R. Incidencia, prevalencia y mortalidad de Cáncer en Colombia, 2007-2011: Instituto Nacional de Cancerología; 2015.

  BACKGROUND

• Chicharro, JL., Vaquero, AF. (2006). Fisiología del ejercicio. Ed. Médica Panamericana.

  BACKGROUND

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  PMID: 23444095 BACKGROUND

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  PMID: 16301444 RESULT

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  PMID: 19482512 RESULT

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  PMID: 15273542 RESULT

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  PMID: 20573634 RESULT

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  PMID: 21212429 RESULT

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  PMID: 24325942 RESULT

• 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 RESULT

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  PMID: 26864728 RESULT

• Ministerio de la Proteccion Social (Colombia). Guía de práctica clínica (GPC) para la detección temprana, el diagnóstico, tratamiento integral, seguimiento y rehabilitación de pacientes con diagnostico de cáncer de colon y recto 2013.

  RESULT

• Van Cutsem E, Sagaert X, Topal B, Haustermans K, Prenen H. Gastric cancer. Lancet. 2016 Nov 26;388(10060):2654-2664. doi: 10.1016/S0140-6736(16)30354-3. Epub 2016 May 5.

  PMID: 27156933 RESULT

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  PMID: 25608638 RESULT

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  PMID: 26927744 RESULT

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  PMID: 15923576 RESULT

• Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009 Jun;10(6):598-605. doi: 10.1016/S1470-2045(09)70031-2.

  PMID: 19482248 RESULT

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• Alcalde-Escribano JR-L, P. Acosta,F. Landa, I. Lorenzo,S, Villeta-Plaza RJE. Estudio Delphi para el desarrollo de pautas de indicación de pruebas preoperatorias. Consenso de anestesiólogos y cirujanos. Rev Calidad Asistencial. 2002;17(1):34-42.

  RESULT

• Wilmore, JH., Costill, DL. (2004). Fisiología del esfuerzo y del deporte. Editorial Paidotribo.

  RESULT

• Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.

  PMID: 17989266 RESULT

• 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 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Liver Neoplasms; Gastrointestinal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Behavior

Study Officials

• Oscar A Guevara, MD MSc

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Guevara, MD, MSc

CONTACT

57+14320106; oguevarac@cancer.gov.co

Kelly Chacon, FT

CONTACT

57+14320106; krchacona@unal.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows: * Week 1: heart rate target: 50% of maximum heart rate * Week 2: heart rate target: 60% of maximum heart rate * Week 3: heart rate target: 70% of maximum heart rate * Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist. The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 6, 2018
• Study Start: April 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: December 31, 2019
• Last Updated: January 24, 2019

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)