ParaplegiaNCT04011137
High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury
A study testing Exercise in people with Paraplegia, run by University of Bath at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Paraplegia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Paraplegia
- Being tested
- Exercise
- Keywords
- high-intensity interval training, postprandial metabolism
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Arm-cranking exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No exercise - 30-min of rest |
| High-intensity interval training | Experimental | 8 x 60 s intervals at 70% peak power output (intersperesed with 60 s recovery intervals at 10% peak power output) Receives: Other: Exercise |
| Moderate-intensity continous training | Experimental | 25 min at 45% peak power output Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial triglyceride concentrations
Postprandial triglyceride concentrations in serum samples
Measured: 6 hours
Secondary outcomes (9)
Postprandial glucose concentrations
Postprandial glucose concentrations in serum samples
Measured: 6 hours
Postprandial insulin concentrations
Postprandial insulin concentrations in serum samples
Measured: 6 hours
Postprandial non-esterified fatty acid concentrations
Postprandial non-esterified fatty acid concentrations in serum samples
Measured: 6 hours
Postprandial substrate oxidation
Postprandial substrate oxidation determined by indirect calorimetry
Measured: 6 hours
Rating of Perceived Exertion
Global, central, and local rating of perceived exertion during exercise
Measured: 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
Heart rate during exercise
Measured: 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
Affect measured through the Feeling Scale (FS) during exercise. FS is a one item scale ranging from +5 ("Very good") to -5 ("Very bad").
Measured: 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
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.
Measured: 30 minutes post-exercise
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").
Measured: 30-minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Apr 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Bilzon, University of Bath
- Investigators
- James Bizon, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011137
- Sponsor's protocol ID
- EP 17/18 141
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2019
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33560775
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper-body High-intensity Interval Training on Postprandial Metabolic Control in Persons With Chronic Paraplegia
- ClinicalTrials.gov ID
- NCT04011137
- Acronym / sponsor ID
- EP 17/18 141
- Conditions
- Paraplegia
- Keywords
- high-intensity interval training, postprandial metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No exercise - 30-min of rest |
| High-intensity interval training | Experimental | Other: Exercise8 x 60 s intervals at 70% peak power output (intersperesed with 60 s recovery intervals at 10% peak power output) |
| Moderate-intensity continous training | Experimental | Other: Exercise25 min at 45% peak power output |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseArm-cranking exercise | Other | High-intensity interval training, Moderate-intensity continous training |
Primary outcome
Postprandial triglyceride concentrations
Time frame: 6 hours
Postprandial triglyceride concentrations in serum samples
9 secondary outcomes
Postprandial glucose concentrations
Time frame: 6 hours
Postprandial insulin concentrations
Time frame: 6 hours
Postprandial non-esterified fatty acid concentrations
Time frame: 6 hours
Postprandial substrate oxidation
Time frame: 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)
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)
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)
Exercise Enjoyment
Time frame: 30 minutes post-exercise
Self-efficacy
Time frame: 30-minutes post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 33560775Farrow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Bizon principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Paraplegia, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial triglyceride concentrations (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.