High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT04397250|
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : July 29, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Paraplegia||Behavioral: High-intensity interval training||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: High-intensity interval training
Participants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week.
Behavioral: High-intensity interval training
No Intervention: Control
Participants will be asked to continue their habitual lifestyle
- 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
- Body mass [ Time Frame: 6 weeks ]Measured using electronic wheelchair scales
- Waist and hip circumference [ Time Frame: 6 weeks ]Measured using a non-metallic tape
- Total body fat percentage [ Time Frame: 6 weeks ]Measured using duel-energy x-ray absorptiometry
- Total Fat Mass [ Time Frame: 6 weeks ]Measured using duel-energy x-ray absorptiometry
- Total Fat-Free Mass [ Time Frame: 6 weeks ]Measured using duel-energy x-ray absorptiometry
- Visceral Adipose Tissue [ Time Frame: 6 weeks ]Measured using duel-energy x-ray absorptiometry
- Systolic and diastolic blood pressure [ Time Frame: 6 weeks ]Measuring using a automated sphygmomanometer
- Resting metabolic rate [ Time Frame: 6 weeks ]Measured using indirect calorimetry
- Time spent in different physical activity intensities (MET categories) (minutes) [ Time Frame: 6 weeks ]Time spent in different physical activity intensities across 7-days (MET categories) (minutes)
- Energy expended in different physical activity intensities (MET categories) (kJ or kcal) [ Time Frame: 6 weeks ]Energy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)
- Energy intake and dietary macronutrient composition [ Time Frame: 6 weeks ]Estimated using a 7-day weighed food diary
- Fasting metabolite/hormone/inflammatory profile [ Time Frame: 6 weeks ]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
- Postprandial metabolites [ Time Frame: 6 weeks ]Assessment of blood glucose and insulin
- Shoulder Pain [ Time Frame: 6 weeks ]Measured using a validated questionnaire
- Exercise Self-Efficacy [ Time Frame: 6 weeks ]Measuring using a validated questionnaire
- Health-related quality of life [ Time Frame: 6 weeks ]Measured using a validated questionnaire
- Fatigue [ Time Frame: 6 weeks ]Measured using a validated questionnaire
- Independence [ Time Frame: 6 weeks ]Measured using a validated questionnaire
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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|
- 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)
- 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
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): NCT04397250
|Contact: James Bilzon||01225 email@example.com|
|University of Bath||Recruiting|
|Bath, United Kingdom, BA2 7AY|
|Contact: Matthew Farrow firstname.lastname@example.org|
|Principal Investigator:||James Bizon||University of Bath|
|Responsible Party:||James Bilzon, Professor, University of Bath|
|Other Study ID Numbers:||
|First Posted:||May 21, 2020 Key Record Dates|
|Last Update Posted:||July 29, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
high-intensity interval training
Nervous System Diseases