- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011137
High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury
The Effect of Upper-body High-intensity Interval Training on Postprandial Metabolic Control in Persons With Chronic Paraplegia
Persons with chronic paraplegia at an increased risk of developing cardiovascular disease and type-2 diabetes compared to the able-bodied population. There is mounting evidence from the able-bodied literature that high-intensity interval training (HIIT) is more effective than moderate-intensity continuous training (MICT) at improving markers of cardiometabolic health. Before we can understand the long-term training effects of HIIT in this population, it is important to compare the acute metabolic responses to a typical mixed-macronutrient meal following both exercise modalities.
This study is recruiting adults (aged 18-65 years) with paraplegia (T2 or below) who sustained their spinal cord injury more than one-year ago. Participants will need to attend the laboratory at the University of Bath on four separate occasions, once for preliminary testing, and three times for study trials.
Study Overview
Detailed Description
The aim of this research is to determine the metabolic responses to a mixed-meal tolerance test following a bout of HIIT and MICT in persons with chronic paraplegia. The hypothesis is that HIIT and MICT will be more effective at reducing the total triglyceride responses compared to a resting control condition.
Preliminary measurements:
Preliminary testing will include anthropometric measurements of supine length, weight, waist and hip circumferences, and resting blood pressure. There will also be an assessment of resting metabolic rate, sub-maximal and maximal exercise capacity, and a HIIT familiarisation session. All of the exercise protocols will take place on an arm crank ergometer at the University of Bath.
Physical activity monitoring:
For 7 days, participants will be fitted with a physical activity monitor (Actiheart™). Participants should not make any conscious changes to their normal lifestyle habits/routines during this period.
Main trial days:
In the 2 days prior to the main trial day, participants will be asked to record their food and drink intake and 48 hours before they should refrain from performing any strenuous physical activity. In the 24 hours prior participants should also refrain from consuming any alcohol or caffeine.
Following a 10-hour overnight fast, an expired gas sample and venepuncture blood sample will be taken prior to exercise. Participants will then perform a bout of HIIT, MICT or a resting control condition. Following exercise, a cannula will be inserted into a vein and baseline blood sample(s) taken for analysis of metabolic markers.
The participant will then be asked to consume a smoothie, consisting of peanut butter, banana, coconut oil, sugar, and chocolate-flavoured whey protein powder. The meal should be consumed within 10 minutes and blood samples will be taken from the cannula at 15, 30, 45 60, and 90 minutes and then at every hour for 6 hours after consumption of the meal to monitor changes in metabolic and inflammatory markers. Expired gas samples will also be taken hourly and indirect calorimetry will be used to estimate relative fat and carbohydrate metabolism in response to the meal.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bath, United Kingdom, BA2 7AY
- Department for Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals with a chronic (>12 months post-injury) SCI below T2
- Individuals who spend >75% of their waking day in a wheelchair
- Weight stable (weight not changed by >3% over the last 3 months)
Exclusion Criteria:
- Individuals who an acute (<12 months post-injury) SCI
- Individuals who spend <75% of their waking day in a wheelchair
- Individuals on type-2 diabetes medication
- Individuals with a peanut allergy
- Individuals who self-report use of lipid-lowering agents
- Individuals self-reporting active medical issues (pressure sores, urinary tract infections, cardiac disorders, musculoskeletal complaints of the upper extremities, or cardiovascular contraindications to exercise testing)
- Individuals who report uncontrolled or regular autonomic dysreflexia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No exercise - 30-min of rest
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|
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Experimental: High-intensity interval training
8 x 60 s intervals at 70% peak power output (intersperesed with 60 s recovery intervals at 10% peak power output)
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Arm-cranking exercise
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Experimental: Moderate-intensity continous training
25 min at 45% peak power output
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Arm-cranking exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial triglyceride concentrations
Time Frame: 6 hours
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Postprandial triglyceride concentrations in serum samples
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial glucose concentrations
Time Frame: 6 hours
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Postprandial glucose concentrations in serum samples
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6 hours
|
|
Postprandial insulin concentrations
Time Frame: 6 hours
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Postprandial insulin concentrations in serum samples
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6 hours
|
|
Postprandial non-esterified fatty acid concentrations
Time Frame: 6 hours
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Postprandial non-esterified fatty acid concentrations in serum samples
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6 hours
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Postprandial substrate oxidation
Time Frame: 6 hours
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Postprandial substrate oxidation determined by indirect calorimetry
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6 hours
|
|
Rating of Perceived Exertion
Time Frame: MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)
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Global, central, and local rating of perceived exertion during exercise
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MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)
|
|
Heart Rate
Time Frame: MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)
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Heart rate during exercise
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MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)
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Affect
Time Frame: MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)
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Affect measured through the Feeling Scale (FS) during exercise.
FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").
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MICT: End of Warm-Up, 6 minutes 15 seconds, 12 minutes 30 seconds, 18 minutes 45 seconds, End of Exercise. HIIT: End of Warm-Up, 8 minutes, 12 minutes, 16 minutes, 20 minutes)
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Exercise Enjoyment
Time Frame: 30 minutes post-exercise
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Enjoyment measured by the Physical Activity Enjoyment Scale (PACES).
PACES is a 17-item scale, with each item scored from 1 to 7. The total score will be calculated.
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30 minutes post-exercise
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Self-efficacy
Time Frame: 30-minutes post-exercise
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Confidence in ability to perform exercise performed during trial in the next 4 weeks measured using a 5-item scale ranging from 0% ("Not at all" to 100% ("Extremely confident").
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30-minutes post-exercise
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Bizon, University of Bath
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP 17/18 141
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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