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High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT04011137
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
James Bilzon, University of Bath

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.


Condition or disease Intervention/treatment Phase
Paraplegia Other: Exercise Not Applicable

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 : 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
No exercise - 30-min of rest
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)
Other: Exercise
Arm-cranking exercise

Experimental: Moderate-intensity continous training
25 min at 45% peak power output
Other: Exercise
Arm-cranking exercise




Primary Outcome Measures :
  1. Postprandial triglyceride concentrations [ Time Frame: 6 hours ]
    Postprandial triglyceride concentrations in serum samples


Secondary Outcome Measures :
  1. Postprandial glucose concentrations [ Time Frame: 6 hours ]
    Postprandial glucose concentrations in serum samples

  2. Postprandial insulin concentrations [ Time Frame: 6 hours ]
    Postprandial insulin concentrations in serum samples

  3. Postprandial non-esterified fatty acid concentrations [ Time Frame: 6 hours ]
    Postprandial non-esterified fatty acid concentrations in serum samples

  4. Postprandial cholesterol, HDL, and LDL concentrations [ Time Frame: 6 hours ]
    Postprandial cholesterol, HDL, and LDL concentrations in serum samples

  5. Postprandial substrate oxidation [ Time Frame: 6 hours ]
    Postprandial substrate oxidation determined by indirect calorimetry

  6. 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) ]
    Global, central, and local rating of perceived exertion during exercise

  7. 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) ]
    Heart rate during exercise

  8. 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) ]
    Affect measured through the Feeling Scale (FS) during exercise. FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").

  9. Exercise Enjoyment [ Time Frame: 30 minutes post-exercise ]
    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.

  10. Self-efficacy [ Time Frame: 30-minutes post-exercise ]
    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").



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011137


Contacts
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Contact: James Bilzon, Professor 01225 383174 j.bilzon@bath.ac.uk

Locations
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United Kingdom
Department for Health Recruiting
Bath, United Kingdom, BA2 7AY
Contact: James Bilzon, Professor    01225 383174    j.bilzon@bath.ac.uk   
Sponsors and Collaborators
University of Bath
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Responsible Party: James Bilzon, Professor, University of Bath
ClinicalTrials.gov Identifier: NCT04011137    
Other Study ID Numbers: EP 17/18 141
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Bilzon, University of Bath:
high-intensity interval training
postprandial metabolism
Additional relevant MeSH terms:
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Paraplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases