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HIIT vs MICT on Cardiometabolic Health After SCI

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ClinicalTrials.gov Identifier: NCT03808363
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 17, 2019
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)
Estimated 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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 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 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. HbA1c [ Time Frame: 6 weeks ]
    Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk

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

  6. IL-6 [ Time Frame: 6 weeks ]
    IL-6 will will be used as an 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. VO2 peak [ Time Frame: 6 weeks ]
    VO2 peak will be measured by a Moxus system to determine changes in fitness


Secondary Outcome Measures :
  1. PACES questionnaire [ Time Frame: 6 weeks ]
    All participants will complete the physical activity enjoyment scale (PACES) to indicate enjoyment of HIIT



Information from the National Library of Medicine

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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


Contacts
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Contact: David Ditor, PhD 905 688 5550 ext 5338 dditor@brocku.ca

Locations
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Canada, Ontario
Brock University Recruiting
St. Catherines, Ontario, Canada
Contact: David Ditor, PhD    905 688 5550 ext 5338    dditor@brocku.ca   
Principal Investigator: Mitchel Gibson, BKin         
Principal Investigator: Aaron Donst, BKin         
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     History of Changes
Other Study ID Numbers: 18-022-DITOR
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
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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Cardiovascular Diseases
Metabolic Syndrome
Spinal Cord Injuries
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries