Skip to content

High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury

The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04397250
Enrollment
32
Registered
2020-05-21
Start date
2020-10-01
Completion date
2022-12-31
Last updated
2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraplegia

Keywords

high-intensity interval training, cardiometabolic health

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 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.

Interventions

BEHAVIORALHigh-intensity interval training

Arm-cranking exercise

Sponsors

University of Bath
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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 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

Design outcomes

Primary

MeasureTime frameDescription
Fasting insulin6 weeksSerum insulin concentration
Peak aerobic capacity6 weeksMeasured using a incremental ramp protocol on a arm crank ergometer
Peak power output6 weeksMaximum power output achieved during peak aerobic capacity test

Secondary

MeasureTime frameDescription
Total Fat Mass6 weeksMeasured using duel-energy x-ray absorptiometry
Total Fat-Free Mass6 weeksMeasured using duel-energy x-ray absorptiometry
Visceral Adipose Tissue6 weeksMeasured using duel-energy x-ray absorptiometry
Systolic and diastolic blood pressure6 weeksMeasuring using a automated sphygmomanometer
Resting metabolic rate6 weeksMeasured using indirect calorimetry
Time spent in different physical activity intensities (MET categories) (minutes)6 weeksTime spent in different physical activity intensities across 7-days (MET categories) (minutes)
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)6 weeksEnergy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)
Body mass6 weeksMeasured using electronic wheelchair scales
Fasting metabolite/hormone/inflammatory profile6 weeksAssessment 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 metabolites6 weeksAssessment of blood glucose and insulin
Shoulder Pain6 weeksMeasured using a validated questionnaire
Exercise Self-Efficacy6 weeksMeasuring using a validated questionnaire
Health-related quality of life6 weeksMeasured using a validated questionnaire
Fatigue6 weeksMeasured using a validated questionnaire
Independence6 weeksMeasured using a validated questionnaire
Energy intake and dietary macronutrient composition6 weeksEstimated using a 7-day weighed food diary
Waist and hip circumference6 weeksMeasured using a non-metallic tape
Total body fat percentage6 weeksMeasured using duel-energy x-ray absorptiometry

Countries

United Kingdom

Contacts

Primary ContactJames Bilzon
j.bilzon@bath.ac.uk01225 383174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026