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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03808363
Other study ID # 18-022-DITOR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date December 15, 2019

Study information

Verified date January 2020
Source Brock University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date December 15, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Brock University St. Catherines Ontario

Sponsors (1)

Lead Sponsor Collaborator
Brock University

Country where clinical trial is conducted

Canada, 

Outcome

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