Effectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI

Study Overview
=================
Brief Summary
-----------------
Testing the efficacy of high intensity interval training (HIIT), as compared to current research supporting moderate intensity continuous training (MICT), as a means to improve cardiometabolic health after spinal cord injury.

Detailed Description
-----------------
This study aims to challenge the effectiveness of the current aerobic exercise recommendations for individuals with spinal cord injuries (SCI). Currently, moderate intensity continuous training (MICT) is suggested however this study intends to explore the effectiveness of high intensity interval training (HIIT). To do so, approximately 8 individuals with SCI will be undergo a 6 week HIIT intervention consisting of 3 sessions per week. With a focus on cardiometabolic health markers (listed in outcome measure section), we aim to provide support for HIIT as a viable method of mitigating cardiovascular risk in a SCI population.

Official Title
-----------------
High-intensity Interval Training Versus Moderate Intensity Continuous Training as a Means to Improve Cardiometabolic Health After Spinal Cord Injury

Conditions
-----------------
Metabolic Syndrome, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: High Intensity Interval Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a spinal cord injury (paraplegia or tetraplegia, complete or incomplete) who are at least one-year post injury. Declared medically stable, and able to communicate clearly in English.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 6 week exercise intervention testing the efficacy of high intensity interval training as compared to current research supporting moderate intensity continuous exercise as a means to mitigate cardiometabolic decline following spinal cord injury
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training Group<br>Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks | Other: High Intensity Interval Training<br>* Participants assigned to this group will perform a very mild 5-minute warm-up (0 resistance, and 60 rpm), followed by 5 one-minute bouts of high intensity exercise, with 90 seconds between each bout. These bouts will be followed by a 3-minute cool down (0 resistance, and 60 rpm). The high-intensity exercise will be performed at an intensity of 17 on the Borg rating of perceived exertion (RPE) scale (very hard), and the 90 second active rest intervals will be performed at an intensity of 7-9 (very, very light - very light). The exercise will be performed on the NuStep machine 3 times a week for 6 weeks.<br>* Other names: HIIT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference (inches) | Central adiposity will be measured by tape measure to monitor possible weight loss | 6 weeks | 
| Cholesterol | Total and HDL cholesterol will be measured in serum | 6 weeks | 
| Triglycerides | Triglycerides will be measured in serum | 6 weeks | 
| Glycated Hemoglobin (HbA1c) | Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk | 6 weeks | 
| Tumor necrosis factor (TNF-a) | TNF-a will be used as an inflammatory representative and will be measured in serum | 6 weeks | 
| Interleukin - 10 (IL-10) | IL-10 will will be used as an anti-inflammatory representative and will be measured in serum | 6 weeks | 
| Pulse Wave Velocity | Arterial stiffness, a common measure for cardiac risk will be measured | 6 weeks | 
| Blood pressure | Measured through a digital cuff, the focus will be on both systolic and diastolic | 6 weeks | 
| Peak Oxygen Consumption (VO2 peak) | VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness | 6 weeks | 
| C Reactive Protein (CRP) | CRP will will be used as an inflammatory representative and will be measured in serum | 6 weeks | 
| Leptin | Leptin will will be used as a body fat representative and will be measured in serum | 6 weeks | 
| Adiponectin | Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Enjoyment Scale (PACES) | All participants will complete the physical activity enjoyment scale (PACES) to indicate enjoyment of HIIT. With a total of 18 questions, options 1 through 7 going from a positive to a negative overall experience with the HIIT protocol will be documented. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Spinal Cord Injury, Cardiovascular Disease, High Intensity Interval Training