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High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.

Primary Purpose

Colorectal Cancer, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HIT
MCT
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring prehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects eligible to enter the study will include those aged 18 and above and referred electively for resection of malignant colorectal lesions.

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions interfering with the ability to perform exercise at home or to complete the testing procedures. Poor English and French comprehension.

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIT

MCT

Arm Description

Preoperative nutrition, relaxation strategies + high intensity interval training (HIT). HIT alternates a series of high-intensity bouts with relief period. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.

Preoperative nutrition, relaxation strategies + high intensity interval training (MCT). MCT is continuous exercise with a constant intensity below anaerobic threshold. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.

Outcomes

Primary Outcome Measures

Oxygen consumption (VO2)
Cardiopulmonary exercise testing (CPET) will be conducted on a cycle ergometer. Coupling expired gas analysis with minute ventilation, It will provide oxygen consumption during exercise.

Secondary Outcome Measures

Six-minute walking distance.
Using a 6-minute walk test, subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk.
Sit-to-Stand test
Sit-to-Stand test is measured by the Senior Fitness Test, to assess an individuals lower-body strength. This is done by having the individual sit on a chair and attempt to stand as many times in a maximum of 30 seconds.
Community Health Activities Model Program for Seniors (CHAMPS) score
Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities. Continuos variable, measured in kcal/week, minimum score 3.5, higher value from baseline will represent a better outcome.
Hospital Anxiety and Depression Scale (HADS) score
Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress. Continuos variable 0-21 (0-7 normal value, 11-21 anxiety/depression), higher value from baseline will represent a worse outcome.

Full Information

First Posted
November 23, 2017
Last Updated
March 20, 2018
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03361150
Brief Title
High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.
Official Title
High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

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

5. Study Description

Brief Summary
Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.
Detailed Description
All patients will receive prehabilitation preoperatively for 4 weeks, that is composed of 3 elements, exercise, nutritional supplements and psychological coping strategies. Both exercise protocol will be supervised, 3-time per week, in-hospital programs. Patients will be randomized to perform either HIT or MC training. Exercise intensity will be defined and personalized on the individual values at cardiopulmonary exercise testing (CPET). Patients' nutritional status and dietary intake will be assessed by the nutritionist, and supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Physical Activity
Keywords
prehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIT
Arm Type
Experimental
Arm Description
Preoperative nutrition, relaxation strategies + high intensity interval training (HIT). HIT alternates a series of high-intensity bouts with relief period. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.
Arm Title
MCT
Arm Type
Active Comparator
Arm Description
Preoperative nutrition, relaxation strategies + high intensity interval training (MCT). MCT is continuous exercise with a constant intensity below anaerobic threshold. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.
Intervention Type
Procedure
Intervention Name(s)
HIT
Intervention Description
Both exercise protocol will be personalized, 3 times per week, 40-min exercise. HIT alternates a series of high-intensity bouts with relief period. MCT is continuous exercise with a constant intensity below anaerobic threshold.
Intervention Type
Procedure
Intervention Name(s)
MCT
Intervention Description
Both exercise protocol will be personalized, 3 times per week, 40-min exercise. MCT is continuous exercise with a constant intensity below anaerobic threshold.
Primary Outcome Measure Information:
Title
Oxygen consumption (VO2)
Description
Cardiopulmonary exercise testing (CPET) will be conducted on a cycle ergometer. Coupling expired gas analysis with minute ventilation, It will provide oxygen consumption during exercise.
Time Frame
4 weeks (before surgery)
Secondary Outcome Measure Information:
Title
Six-minute walking distance.
Description
Using a 6-minute walk test, subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk.
Time Frame
4 weeks (before surgery)
Title
Sit-to-Stand test
Description
Sit-to-Stand test is measured by the Senior Fitness Test, to assess an individuals lower-body strength. This is done by having the individual sit on a chair and attempt to stand as many times in a maximum of 30 seconds.
Time Frame
4 weeks (before surgery)
Title
Community Health Activities Model Program for Seniors (CHAMPS) score
Description
Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities. Continuos variable, measured in kcal/week, minimum score 3.5, higher value from baseline will represent a better outcome.
Time Frame
4 weeks (before surgery)
Title
Hospital Anxiety and Depression Scale (HADS) score
Description
Depression and anxiety will be assessed by the Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress. Continuos variable 0-21 (0-7 normal value, 11-21 anxiety/depression), higher value from baseline will represent a worse outcome.
Time Frame
4 weeks (before surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects eligible to enter the study will include those aged 18 and above and referred electively for resection of malignant colorectal lesions. Exclusion Criteria: American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions interfering with the ability to perform exercise at home or to complete the testing procedures. Poor English and French comprehension.
Facility Information:
Facility Name
Montreal General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25076007
Citation
Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
Results Reference
background
PubMed Identifier
32976204
Citation
Minnella EM, Ferreira V, Awasthi R, Charlebois P, Stein B, Liberman AS, Scheede-Bergdahl C, Morais JA, Carli F. Effect of two different pre-operative exercise training regimens before colorectal surgery on functional capacity: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):969-978. doi: 10.1097/EJA.0000000000001215.
Results Reference
derived

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High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.

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