search
Back to results

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

Primary Purpose

Paraplegia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Paraplegia focused on measuring high-intensity interval training, postprandial metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department for Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

High-intensity interval training

Moderate-intensity continous training

Arm Description

No exercise - 30-min of rest

8 x 60 s intervals at 70% peak power output (intersperesed with 60 s recovery intervals at 10% peak power output)

25 min at 45% peak power output

Outcomes

Primary Outcome Measures

Postprandial triglyceride concentrations
Postprandial triglyceride concentrations in serum samples

Secondary Outcome Measures

Postprandial glucose concentrations
Postprandial glucose concentrations in serum samples
Postprandial insulin concentrations
Postprandial insulin concentrations in serum samples
Postprandial non-esterified fatty acid concentrations
Postprandial non-esterified fatty acid concentrations in serum samples
Postprandial substrate oxidation
Postprandial substrate oxidation determined by indirect calorimetry
Rating of Perceived Exertion
Global, central, and local rating of perceived exertion during exercise
Heart Rate
Heart rate during exercise
Affect
Affect measured through the Feeling Scale (FS) during exercise. FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").
Exercise Enjoyment
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.
Self-efficacy
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").

Full Information

First Posted
July 3, 2019
Last Updated
July 26, 2022
Sponsor
University of Bath
search

1. Study Identification

Unique Protocol Identification Number
NCT04011137
Brief Title
High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury
Official Title
The Effect of Upper-body High-intensity Interval Training on Postprandial Metabolic Control in Persons With Chronic Paraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia
Keywords
high-intensity interval training, postprandial metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No exercise - 30-min of rest
Arm Title
High-intensity interval training
Arm Type
Experimental
Arm Description
8 x 60 s intervals at 70% peak power output (intersperesed with 60 s recovery intervals at 10% peak power output)
Arm Title
Moderate-intensity continous training
Arm Type
Experimental
Arm Description
25 min at 45% peak power output
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Arm-cranking exercise
Primary Outcome Measure Information:
Title
Postprandial triglyceride concentrations
Description
Postprandial triglyceride concentrations in serum samples
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Postprandial glucose concentrations
Description
Postprandial glucose concentrations in serum samples
Time Frame
6 hours
Title
Postprandial insulin concentrations
Description
Postprandial insulin concentrations in serum samples
Time Frame
6 hours
Title
Postprandial non-esterified fatty acid concentrations
Description
Postprandial non-esterified fatty acid concentrations in serum samples
Time Frame
6 hours
Title
Postprandial substrate oxidation
Description
Postprandial substrate oxidation determined by indirect calorimetry
Time Frame
6 hours
Title
Rating of Perceived Exertion
Description
Global, central, and local rating of perceived exertion during exercise
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)
Title
Heart Rate
Description
Heart rate during exercise
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)
Title
Affect
Description
Affect measured through the Feeling Scale (FS) during exercise. FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").
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)
Title
Exercise Enjoyment
Description
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.
Time Frame
30 minutes post-exercise
Title
Self-efficacy
Description
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").
Time Frame
30-minutes post-exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Bizon
Organizational Affiliation
University of Bath
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Health
City
Bath
ZIP/Postal Code
BA2 7AY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33560775
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs