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

Primary Purpose

Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Preoperative exercise program
Sponsored by
Instituto Nacional de Cancerologia, Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stomach Neoplasms focused on measuring Gastrointestinal Neoplasms, Exercise, Preoperative Period, Preoperative Care

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 45 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

Exclusion criteria:

  • 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.

Sites / Locations

  • Instituto Nacional de CancerologíaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preoperative exercise program

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

exercise-related adverse events
any unexpected reaction secondary to the exercise program. This could be mild (nausea, fall, joint pain, tendinitis) or severe (syncope, fracture, myocardial infarction).
program adherence
frequency of patients who will complete at least the 3 week program.
Peak oxygen comsumption - 3 weeks
peak oxygen consumption measured in ml/kg/min using the American College of Sports

Full Information

First Posted
January 11, 2018
Last Updated
January 23, 2019
Sponsor
Instituto Nacional de Cancerologia, Columbia
Collaborators
Universidad Nacional de Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT03423056
Brief Title
Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.
Official Title
Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Cancerologia, Columbia
Collaborators
Universidad Nacional de Colombia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Gastrointestinal - origin cancer is one of the most frequent causes of cancer worldwide ; the primary surgical management is the standard treatment, however, the postoperative complications rate could be up to 35% . Patients with gastrointestinal - origin cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal 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, liver, colon or rectal cancer), scheduled for surgery in 4 weeks or more since recruitment and without electrocardiographic abnormalities. The patients will be selected from the gastrointestinal unit surgical schedule. The eligible patients will be invited to participate and after their agreement to participate and to do the informed consent process, they will be scheduled to the basal assessment. This aerobic capacity assessment will be done with the 6-minute walk test. After the basal measurement, two physical therapists will prescribe an individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will be programmed 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Liver Neoplasm
Keywords
Gastrointestinal Neoplasms, Exercise, Preoperative Period, Preoperative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative exercise program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Preoperative exercise program
Other Intervention Name(s)
Preoperative aerobic exercise short program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak oxygen comsumption
Description
peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation
Time Frame
4 weeks after the exercise program beginning
Secondary Outcome Measure Information:
Title
exercise-related adverse events
Description
any unexpected reaction secondary to the exercise program. This could be mild (nausea, fall, joint pain, tendinitis) or severe (syncope, fracture, myocardial infarction).
Time Frame
3 and 4 weeks after the exercise program beginning
Title
program adherence
Description
frequency of patients who will complete at least the 3 week program.
Time Frame
3 weeks after the exercise program beginning.
Title
Peak oxygen comsumption - 3 weeks
Description
peak oxygen consumption measured in ml/kg/min using the American College of Sports
Time Frame
3 weeks after the exercise program beginning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 45 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 Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Guevara, MD, MSc
Phone
57+14320106
Ext
5973
Email
oguevarac@cancer.gov.co
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Chacon, FT
Phone
57+14320106
Ext
5973
Email
krchacona@unal.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar A Guevara, MD MSc
Organizational Affiliation
Instituto Nacional de Cancerología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cancerología
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0000
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria T. Vallejo, Md
Phone
+5714320160
Ext
5973
Email
mvallejo@cancer.gov.co

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers
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Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.

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