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

Study Overview
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Brief Summary
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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
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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.

Official Title
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High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.

Conditions
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Colorectal Cancer, Physical Activity

Intervention / Treatment
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* Procedure: HIT
* Procedure: MCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIT<br>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<br>* 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.<br>|
| Active Comparator: MCT<br>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<br>* Both exercise protocol will be personalized, 3 times per week, 40-min exercise. MCT is continuous exercise with a constant intensity below anaerobic threshold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks (before surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks (before surgery) | 
| 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. | 4 weeks (before surgery) | 
| 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. | 4 weeks (before surgery) | 
| 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. | 4 weeks (before surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation