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

July 26, 2022 updated by: James Bilzon, University of Bath

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial triglyceride concentrations
Time Frame: 6 hours
Postprandial triglyceride concentrations in serum samples
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial glucose concentrations
Time Frame: 6 hours
Postprandial glucose concentrations in serum samples
6 hours
Postprandial insulin concentrations
Time Frame: 6 hours
Postprandial insulin concentrations in serum samples
6 hours
Postprandial non-esterified fatty acid concentrations
Time Frame: 6 hours
Postprandial non-esterified fatty acid concentrations in serum samples
6 hours
Postprandial substrate oxidation
Time Frame: 6 hours
Postprandial substrate oxidation determined by indirect calorimetry
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)
Global, central, and local rating of perceived exertion during exercise
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)
Heart rate during exercise
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
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").
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)
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.
30 minutes post-exercise
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").
30-minutes post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James Bizon, University of Bath

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (Actual)

July 8, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • EP 17/18 141

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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