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

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ClinicalTrials.gov Identifier: NCT03361150
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Colorectal Cancer Physical Activity Procedure: HIT Procedure: MCT

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HIT
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.
Procedure: HIT
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.
Active Comparator: MCT
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.
Procedure: MCT
Both exercise protocol will be personalized, 3 times per week, 40-min exercise. MCT is continuous exercise with a constant intensity below anaerobic threshold.


Outcome Measures

Primary Outcome Measures :
  1. Oxygen consumption (VO2) [ Time Frame: 4 weeks (before surgery) ]
    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 :
  1. Six-minute walking distance. [ Time Frame: 4 weeks (before surgery) ]
    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.

  2. Sit-to-Stand test [ Time Frame: 4 weeks (before surgery) ]
    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.

  3. Community Health Activities Model Program for Seniors (CHAMPS) score [ Time Frame: 4 weeks (before surgery) ]
    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.

  4. Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: 4 weeks (before surgery) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361150


Contacts
Contact: Dr. Francesco Carli 8888-43274 franco.carli@mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montréal, Quebec, Canada, H3G1A4
Contact: Dr. Francesco Carli    8888-43274    franco.carli@mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
More Information

Publications:
Responsible Party: Franco Carli, Clinical Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03361150     History of Changes
Other Study ID Numbers: 15-244-MUHC
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Franco Carli, McGill University Health Center:
prehabilitation

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases