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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brock University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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