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.
Condition or disease | Intervention/treatment | Phase |
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Paraplegia | Other: Exercise | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | The Effect of Upper-body High-intensity Interval Training on Postprandial Metabolic Control in Persons With Chronic Paraplegia |
Actual Study Start Date : | April 1, 2018 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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No Intervention: Control
No exercise - 30-min of rest
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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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Other: Exercise
Arm-cranking exercise
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Experimental: Moderate-intensity continous training
25 min at 45% peak power output
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Other: Exercise
Arm-cranking exercise
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: James Bilzon, Professor | 01225 383174 | j.bilzon@bath.ac.uk |
United Kingdom | |
Department for Health | Recruiting |
Bath, United Kingdom, BA2 7AY | |
Contact: James Bilzon, Professor 01225 383174 j.bilzon@bath.ac.uk |
Tracking Information | |||||
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First Submitted Date ICMJE | July 3, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | May 19, 2020 | ||||
Actual Study Start Date ICMJE | April 1, 2018 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Postprandial triglyceride concentrations [ Time Frame: 6 hours ] Postprandial triglyceride concentrations in serum samples
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury | ||||
Official Title ICMJE | The Effect of Upper-body High-intensity Interval Training on Postprandial Metabolic Control in Persons With Chronic Paraplegia | ||||
Brief Summary |
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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Paraplegia | ||||
Intervention ICMJE | Other: Exercise
Arm-cranking exercise
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Study Arms ICMJE |
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Publications * | Farrow MT, Maher JL, Nightingale TE, Thompson D, Bilzon JLJ. A Single Bout of Upper-Body Exercise Has No Effect on Postprandial Metabolism in Persons with Chronic Paraplegia. Med Sci Sports Exerc. 2021 May 1;53(5):1041-1049. doi: 10.1249/MSS.0000000000002561. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
11 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04011137 | ||||
Other Study ID Numbers ICMJE | EP 17/18 141 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | James Bilzon, University of Bath | ||||
Study Sponsor ICMJE | University of Bath | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Bath | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |