NCT03808363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

October 22, 2018

Last Update Submit

January 13, 2020

Conditions

Keywords

Metabolic SyndromeSpinal Cord InjuryCardiovascular DiseaseHigh Intensity Interval Training

Outcome Measures

Primary Outcomes (12)

  • Waist circumference (inches)

    Central adiposity will be measured by tape measure to monitor possible weight loss

    6 weeks

  • Cholesterol

    Total and HDL cholesterol will be measured in serum

    6 weeks

  • Triglycerides

    Triglycerides will be measured in serum

    6 weeks

  • Glycated Hemoglobin (HbA1c)

    Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk

    6 weeks

  • Tumor necrosis factor (TNF-a)

    TNF-a will be used as an inflammatory representative and will be measured in serum

    6 weeks

  • Interleukin - 10 (IL-10)

    IL-10 will will be used as an anti-inflammatory representative and will be measured in serum

    6 weeks

  • Pulse Wave Velocity

    Arterial stiffness, a common measure for cardiac risk will be measured

    6 weeks

  • Blood pressure

    Measured through a digital cuff, the focus will be on both systolic and diastolic

    6 weeks

  • Peak Oxygen Consumption (VO2 peak)

    VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness

    6 weeks

  • C Reactive Protein (CRP)

    CRP will will be used as an inflammatory representative and will be measured in serum

    6 weeks

  • Leptin

    Leptin will will be used as a body fat representative and will be measured in serum

    6 weeks

  • Adiponectin

    Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum

    6 weeks

Secondary Outcomes (1)

  • Physical Activity Enjoyment Scale (PACES)

    6 weeks

Study Arms (1)

High Intensity Interval Training Group

EXPERIMENTAL

Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks

Other: High Intensity Interval Training

Interventions

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.

Also known as: HIIT
High Intensity Interval Training Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

Saint Catherines, Ontario, Canada

Location

MeSH Terms

Conditions

Metabolic SyndromeCardiovascular DiseasesSpinal Cord Injuries

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mitchel Gibson, BKin

    Masters Student

    PRINCIPAL INVESTIGATOR
  • Aaron Donst, BKin

    Masters Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David Ditor, PhD - Professor, Kinesiology

Study Record Dates

First Submitted

October 22, 2018

First Posted

January 17, 2019

Study Start

February 1, 2019

Primary Completion

May 30, 2019

Study Completion

December 15, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations