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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808363
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
David Ditor, Brock University

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Cardiovascular Diseases Other: High Intensity Interval Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: High-intensity Interval Training Versus Moderate Intensity Continuous Training as a Means to Improve Cardiometabolic Health After Spinal Cord Injury
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity Interval Training Group
Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks
Other: High Intensity Interval Training
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.
Other Name: HIIT




Primary Outcome Measures :
  1. Waist circumference (inches) [ Time Frame: 6 weeks ]
    Central adiposity will be measured by tape measure to monitor possible weight loss

  2. Cholesterol [ Time Frame: 6 weeks ]
    Total and HDL cholesterol will be measured in serum

  3. Triglycerides [ Time Frame: 6 weeks ]
    Triglycerides will be measured in serum

  4. Glycated Hemoglobin (HbA1c) [ Time Frame: 6 weeks ]
    Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk

  5. Tumor necrosis factor (TNF-a) [ Time Frame: 6 weeks ]
    TNF-a will be used as an inflammatory representative and will be measured in serum

  6. Interleukin - 10 (IL-10) [ Time Frame: 6 weeks ]
    IL-10 will will be used as an anti-inflammatory representative and will be measured in serum

  7. Pulse Wave Velocity [ Time Frame: 6 weeks ]
    Arterial stiffness, a common measure for cardiac risk will be measured

  8. Blood pressure [ Time Frame: 6 weeks ]
    Measured through a digital cuff, the focus will be on both systolic and diastolic

  9. Peak Oxygen Consumption (VO2 peak) [ Time Frame: 6 weeks ]
    VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness

  10. C Reactive Protein (CRP) [ Time Frame: 6 weeks ]
    CRP will will be used as an inflammatory representative and will be measured in serum

  11. Leptin [ Time Frame: 6 weeks ]
    Leptin will will be used as a body fat representative and will be measured in serum

  12. Adiponectin [ Time Frame: 6 weeks ]
    Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum


Secondary Outcome Measures :
  1. Physical Activity Enjoyment Scale (PACES) [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03808363


Locations
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Canada, Ontario
Brock University
St. Catherines, Ontario, Canada
Sponsors and Collaborators
Brock University
Investigators
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Principal Investigator: Mitchel Gibson, BKin Masters Student
Principal Investigator: Aaron Donst, BKin Masters Student

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Responsible Party: David Ditor, David Ditor, PhD - Professor, Kinesiology, Brock University
ClinicalTrials.gov Identifier: NCT03808363    
Other Study ID Numbers: 18-022-DITOR
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Ditor, Brock University:
Metabolic Syndrome
Spinal Cord Injury
Cardiovascular Disease
High Intensity Interval Training
Additional relevant MeSH terms:
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Metabolic Syndrome
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases