Metabolic SyndromeNCT03808363
Effectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI
A study testing High Intensity Interval Training in people with Metabolic Syndrome and Cardiovascular Diseases, run by Brock University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Cardiovascular Diseases
- What is being tested?
- High Intensity Interval Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome, Cardiovascular Diseases
- Being tested
- High Intensity Interval Training
- Keywords
- Metabolic Syndrome, Spinal Cord Injury, Cardiovascular Disease, High Intensity Interval Training
- Medical subject headings
- Metabolic Syndrome, Cardiovascular Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
Also called HIIT
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training Group | Experimental | Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks Receives: Other: High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference (inches)
Central adiposity will be measured by tape measure to monitor possible weight loss
Measured: 6 weeks
Cholesterol
Total and HDL cholesterol will be measured in serum
Measured: 6 weeks
Triglycerides
Triglycerides will be measured in serum
Measured: 6 weeks
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk
Measured: 6 weeks
Tumor necrosis factor (TNF-a)
TNF-a will be used as an inflammatory representative and will be measured in serum
Measured: 6 weeks
Interleukin - 10 (IL-10)
IL-10 will will be used as an anti-inflammatory representative and will be measured in serum
Measured: 6 weeks
Pulse Wave Velocity
Arterial stiffness, a common measure for cardiac risk will be measured
Measured: 6 weeks
Blood pressure
Measured through a digital cuff, the focus will be on both systolic and diastolic
Measured: 6 weeks
Peak Oxygen Consumption (VO2 peak)
VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness
Measured: 6 weeks
C Reactive Protein (CRP)
CRP will will be used as an inflammatory representative and will be measured in serum
Measured: 6 weeks
Leptin
Leptin will will be used as a body fat representative and will be measured in serum
Measured: 6 weeks
Adiponectin
Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum
Measured: 6 weeks
Secondary outcomes (1)
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Feb 2019
- Primary completion30 May 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ditor, Brock University
- Investigators
- Mitchel Gibson, BKin, Principal investigator, Masters StudentAaron Donst, BKin, Principal investigator, Masters Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808363
- Sponsor's protocol ID
- 18-022-DITOR
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training Versus Moderate Intensity Continuous Training as a Means to Improve Cardiometabolic Health After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03808363
- Acronym / sponsor ID
- 18-022-DITOR
- Conditions
- Metabolic Syndrome, Cardiovascular Diseases
- Keywords
- Metabolic Syndrome, Spinal Cord Injury, Cardiovascular Disease, High Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training Group | Experimental | Other: High Intensity Interval TrainingApproximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingAlso: HIITParticipants 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 | High Intensity Interval Training Group |
Primary outcome
Waist circumference (inches)
Time frame: 6 weeks
Central adiposity will be measured by tape measure to monitor possible weight loss
Cholesterol
Time frame: 6 weeks
Total and HDL cholesterol will be measured in serum
Triglycerides
Time frame: 6 weeks
Triglycerides will be measured in serum
Glycated Hemoglobin (HbA1c)
Time frame: 6 weeks
Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk
Tumor necrosis factor (TNF-a)
Time frame: 6 weeks
TNF-a will be used as an inflammatory representative and will be measured in serum
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
Pulse Wave Velocity
Time frame: 6 weeks
Arterial stiffness, a common measure for cardiac risk will be measured
Blood pressure
Time frame: 6 weeks
Measured through a digital cuff, the focus will be on both systolic and diastolic
Peak Oxygen Consumption (VO2 peak)
Time frame: 6 weeks
VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness
C Reactive Protein (CRP)
Time frame: 6 weeks
CRP will will be used as an inflammatory representative and will be measured in serum
Leptin
Time frame: 6 weeks
Leptin will will be used as a body fat representative and will be measured in serum
Adiponectin
Time frame: 6 weeks
Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum
1 secondary outcome
Physical Activity Enjoyment Scale (PACES)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel Gibson, BKin principal investigator
Masters Student
Aaron Donst, BKin principal investigator
Masters Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training in people with Metabolic Syndrome and Cardiovascular Diseases, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (inches) (time frame: 6 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.