Back to resultsEffectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI
Primary Purpose
Metabolic Syndrome, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Interval Training
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Spinal Cord Injury, Cardiovascular Disease, High Intensity Interval Training
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.
Sites / Locations
- Brock University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Intensity Interval Training Group
Arm Description
Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks
Outcomes
Primary Outcome Measures
Waist circumference (inches)
Central adiposity will be measured by tape measure to monitor possible weight loss
Cholesterol
Total and HDL cholesterol will be measured in serum
Triglycerides
Triglycerides will be measured in serum
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk
Tumor necrosis factor (TNF-a)
TNF-a will be used as an inflammatory representative and will be measured in serum
Interleukin - 10 (IL-10)
IL-10 will will be used as an anti-inflammatory representative and will be measured in serum
Pulse Wave Velocity
Arterial stiffness, a common measure for cardiac risk will be measured
Blood pressure
Measured through a digital cuff, the focus will be on both systolic and diastolic
Peak Oxygen Consumption (VO2 peak)
VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness
C Reactive Protein (CRP)
CRP will will be used as an inflammatory representative and will be measured in serum
Leptin
Leptin will will be used as a body fat representative and will be measured in serum
Adiponectin
Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03808363
Brief Title
Effectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI
Official Title
High-intensity Interval Training Versus Moderate Intensity Continuous Training as a Means to Improve Cardiometabolic Health After Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Cardiovascular Diseases
Keywords
Metabolic Syndrome, Spinal Cord Injury, Cardiovascular Disease, High Intensity Interval Training
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training Group
Arm Type
Experimental
Arm Description
Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Other Intervention Name(s)
HIIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Waist circumference (inches)
Description
Central adiposity will be measured by tape measure to monitor possible weight loss
Time Frame
6 weeks
Title
Cholesterol
Description
Total and HDL cholesterol will be measured in serum
Time Frame
6 weeks
Title
Triglycerides
Description
Triglycerides will be measured in serum
Time Frame
6 weeks
Title
Glycated Hemoglobin (HbA1c)
Description
Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk
Time Frame
6 weeks
Title
Tumor necrosis factor (TNF-a)
Description
TNF-a will be used as an inflammatory representative and will be measured in serum
Time Frame
6 weeks
Title
Interleukin - 10 (IL-10)
Description
IL-10 will will be used as an anti-inflammatory representative and will be measured in serum
Time Frame
6 weeks
Title
Pulse Wave Velocity
Description
Arterial stiffness, a common measure for cardiac risk will be measured
Time Frame
6 weeks
Title
Blood pressure
Description
Measured through a digital cuff, the focus will be on both systolic and diastolic
Time Frame
6 weeks
Title
Peak Oxygen Consumption (VO2 peak)
Description
VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness
Time Frame
6 weeks
Title
C Reactive Protein (CRP)
Description
CRP will will be used as an inflammatory representative and will be measured in serum
Time Frame
6 weeks
Title
Leptin
Description
Leptin will will be used as a body fat representative and will be measured in serum
Time Frame
6 weeks
Title
Adiponectin
Description
Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Physical Activity Enjoyment Scale (PACES)
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchel Gibson, BKin
Organizational Affiliation
Masters Student
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aaron Donst, BKin
Organizational Affiliation
Masters Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
St. Catherines
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI
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