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

January 13, 2020 updated by: David Ditor, Brock University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • St. Catherines, Ontario, Canada
        • Brock University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • HIIT

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brock University

Investigators

  • Principal Investigator: Mitchel Gibson, BKin, Masters Student
  • Principal Investigator: Aaron Donst, BKin, Masters Student

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-022-DITOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Diseases

Clinical Trials on High Intensity Interval Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe