ParaplegiaNCT04397250
High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury
A study testing High-intensity interval training 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 an effective way to improve cardiometabolic health outcomes… 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?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 31 Dec 2022
- 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 self-reporting active medical issues (pressure sores, urinary tract infections, cardiac disorders, musculoskeletal complaints of the upper extremities, or cardiovascular contraindications to exercise testing)
- Plans to change lifestyle during the study period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bath
Bath, BA2 7AY
Matthew Farrow, m.t.farrow@bath.ac.uk
About this study
Official title: The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial
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 an effective way to improve cardiometabolic health outcomes, but this effect has yet to be investigated in persons with chronic paraplegia.
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 two occasions (baseline and follow-up testing) separated by eight weeks. Following the first visit, participants will be randomised to a exercise group or control group. For those in the exercise group, participants will be provided with an arm crank ergometer for use in their home, and be asked to perform four exercise sessions per week (30 min each) for six weeks. For those in the control group, participants will be asked to continue their normal lifestyle.
Read the detailed description
The aim of this research is to determine the effect of HIIT (vs. a control group) on biomarkers of cardiometabolic health in persons with chronic paraplegia.
Baseline and follow-up assessments:
Before each visits, participants will be asked to refrain from any strenuous physical activity (2 days prior), consume no caffeine (including tea or coffee) or alcohol (1 day prior), and have fasted for at least 10 hours overnight before arriving to the University of Bath laboratories.
There will be measurements of basic anthropometrics (height, weight, waist and hip circumference), body composition (via a DEXA scan), resting metabolic rate, sub-maximal and maximal exercise capacity, and blood responses following the consumption of a sugary drink.
Physical activity and diet monitoring:
Participants will be asked to monitor their normal diet (weighed food diary) and physical activity patterns (chest-worn strap) over a 1-week period following the first visit, and in the final week of the 6-week intervention/control period.
Exercise intervention:
The 6-week exercise programme or control will start two weeks after the first lab visit. Participants in the exercise group will be asked to wear a heart-rate monitor for all exercise sessions, and upload their data to a smartphone for remote-monitoring by the research team.
- Conditions
- Paraplegia
- Being tested
- High-intensity interval training
- Keywords
- high-intensity interval training, cardiometabolic health
- Medical subject headings
- Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
Arm-cranking exercise
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | Participants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week. Receives: Behavioral: High-intensity interval training |
| Control | No intervention | Participants will be asked to continue their habitual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting insulin
Serum insulin concentration
Measured: 6 weeks
Peak aerobic capacity
Measured using a incremental ramp protocol on a arm crank ergometer
Measured: 6 weeks
Peak power output
Maximum power output achieved during peak aerobic capacity test
Measured: 6 weeks
Secondary outcomes (18)
Body mass
Measured using electronic wheelchair scales
Measured: 6 weeks
Waist and hip circumference
Measured using a non-metallic tape
Measured: 6 weeks
Total body fat percentage
Measured using duel-energy x-ray absorptiometry
Measured: 6 weeks
Total Fat Mass
Measured using duel-energy x-ray absorptiometry
Measured: 6 weeks
Total Fat-Free Mass
Measured using duel-energy x-ray absorptiometry
Measured: 6 weeks
Visceral Adipose Tissue
Measured using duel-energy x-ray absorptiometry
Measured: 6 weeks
Systolic and diastolic blood pressure
Measuring using a automated sphygmomanometer
Measured: 6 weeks
Resting metabolic rate
Measured using indirect calorimetry
Measured: 6 weeks
Time spent in different physical activity intensities (MET categories) (minutes)
Time spent in different physical activity intensities across 7-days (MET categories) (minutes)
Measured: 6 weeks
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Energy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)
Measured: 6 weeks
Energy intake and dietary macronutrient composition
Estimated using a 7-day weighed food diary
Measured: 6 weeks
Fasting metabolite/hormone/inflammatory profile
Assessment of blood glucose, glycated hemoglobin, triglycerides, non-esterified fatty acids, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, leptin, C-reactive protein, interleukin-6, tumour-necrosis factor-alpha, and adiponectin
Measured: 6 weeks
Postprandial metabolites
Assessment of blood glucose and insulin
Measured: 6 weeks
Shoulder Pain
Measured using a validated questionnaire
Measured: 6 weeks
Exercise Self-Efficacy
Measuring using a validated questionnaire
Measured: 6 weeks
Health-related quality of life
Measured using a validated questionnaire
Measured: 6 weeks
Fatigue
Measured using a validated questionnaire
Measured: 6 weeks
Independence
Measured using a validated questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
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
- NCT04397250
- Sponsor's protocol ID
- 20/SW/0051
- Status last verified
- Jul 2022
- First submitted
- 17 May 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farrow M, Maher J, Deere R, Spellanzon B, Williams S, Thompson D, Bilzon JLJ. Effect of high-intensity interval training on cardiometabolic component risks in persons with paraplegia: Results of a randomized controlled trial. Exp Physiol. 2024 Aug;109(8):1253-1266. doi: 10.1113/EP091803. Epub 2024 Jun 24.
PubMed 38924175Farrow MT, Maher J, Thompson D, Bilzon JLJ. Effect of high-intensity interval training on cardiometabolic component risks in persons with paraplegia: Protocol for a randomized controlled trial. Exp Physiol. 2021 May;106(5):1159-1165. doi: 10.1113/EP089110. Epub 2021 Mar 20.
PubMed 33600014
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 High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04397250
- Acronym / sponsor ID
- 20/SW/0051
- Conditions
- Paraplegia
- Keywords
- high-intensity interval training, cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 May 2020 (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 an effective way to improve cardiometabolic health outcomes, but this effect has yet to be investigated in persons with chronic paraplegia.
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 two occasions (baseline and follow-up testing) separated by eight weeks. Following the first visit, participants will be randomised to a exercise group or control group. For those in the exercise group, participants will be provided with an arm crank ergometer for use in their home, and be asked to perform four exercise sessions per week (30 min each) for six weeks. For those in the control group, participants will be asked to continue their normal lifestyle.
Detailed description
The aim of this research is to determine the effect of HIIT (vs. a control group) on biomarkers of cardiometabolic health in persons with chronic paraplegia.
Baseline and follow-up assessments:
Before each visits, participants will be asked to refrain from any strenuous physical activity (2 days prior), consume no caffeine (including tea or coffee) or alcohol (1 day prior), and have fasted for at least 10 hours overnight before arriving to the University of Bath laboratories.
There will be measurements of basic anthropometrics (height, weight, waist and hip circumference), body composition (via a DEXA scan), resting metabolic rate, sub-maximal and maximal exercise capacity, and blood responses following the consumption of a sugary drink.
Physical activity and diet monitoring:
Participants will be asked to monitor their normal diet (weighed food diary) and physical activity patterns (chest-worn strap) over a 1-week period following the first visit, and in the final week of the 6-week intervention/control period.
Exercise intervention:
The 6-week exercise programme or control will start two weeks after the first lab visit. Participants in the exercise group will be asked to wear a heart-rate monitor for all exercise sessions, and upload their data to a smartphone for remote-monitoring by the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: High-intensity interval trainingParticipants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week. |
| Control | No intervention | –Participants will be asked to continue their habitual lifestyle |
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 (5 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 self-reporting active medical issues (pressure sores, urinary tract infections, cardiac disorders, musculoskeletal complaints of the upper extremities, or cardiovascular contraindications to exercise testing)
- Plans to change lifestyle during the study period
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 |
|---|---|---|
| High-intensity interval trainingArm-cranking exercise | Behavioural | High-intensity interval training |
Primary outcome
Fasting insulin
Time frame: 6 weeks
Serum insulin concentration
Peak aerobic capacity
Time frame: 6 weeks
Measured using a incremental ramp protocol on a arm crank ergometer
Peak power output
Time frame: 6 weeks
Maximum power output achieved during peak aerobic capacity test
18 secondary outcomes
Body mass
Time frame: 6 weeks
Waist and hip circumference
Time frame: 6 weeks
Total body fat percentage
Time frame: 6 weeks
Total Fat Mass
Time frame: 6 weeks
Total Fat-Free Mass
Time frame: 6 weeks
Visceral Adipose Tissue
Time frame: 6 weeks
Systolic and diastolic blood pressure
Time frame: 6 weeks
Resting metabolic rate
Time frame: 6 weeks
Time spent in different physical activity intensities (MET categories) (minutes)
Time frame: 6 weeks
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Time frame: 6 weeks
Energy intake and dietary macronutrient composition
Time frame: 6 weeks
Fasting metabolite/hormone/inflammatory profile
Time frame: 6 weeks
Postprandial metabolites
Time frame: 6 weeks
Shoulder Pain
Time frame: 6 weeks
Exercise Self-Efficacy
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Independence
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 38924175Farrow M, Maher J, Deere R, Spellanzon B, Williams S, Thompson D, Bilzon JLJ. Effect of high-intensity interval training on cardiometabolic component risks in persons with paraplegia: Results of a randomized controlled trial. Exp Physiol. 2024 Aug;109(8):1253-1266. doi: 10.1113/EP091803. Epub 2024 Jun 24.
- Derived from this study: PubMed 33600014Farrow MT, Maher J, Thompson D, Bilzon JLJ. Effect of high-intensity interval training on cardiometabolic component risks in persons with paraplegia: Protocol for a randomized controlled trial. Exp Physiol. 2021 May;106(5):1159-1165. doi: 10.1113/EP089110. Epub 2021 Mar 20.
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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 High-intensity interval training 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 5 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Bilzon (01225 383174, j.bilzon@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting insulin (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT04397250, which also lists 2 linked publications.
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.