Clinical trial NCT04397250: High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury
Official title: The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paraplegia
Keywords: high-intensity interval training
cardiometabolic health
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Fasting insulin
timeFrame: 6 weeks
measure: Peak aerobic capacity
timeFrame: 6 weeks
measure: Peak power output
timeFrame: 6 weeks
Secondary outcomes:
measure: Body mass
timeFrame: 6 weeks
measure: Waist and hip circumference
timeFrame: 6 weeks
measure: Total body fat percentage
timeFrame: 6 weeks
measure: Total Fat Mass
timeFrame: 6 weeks
measure: Total Fat-Free Mass
timeFrame: 6 weeks
measure: Visceral Adipose Tissue
timeFrame: 6 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 6 weeks
measure: Resting metabolic rate
timeFrame: 6 weeks
measure: Time spent in different physical activity intensities (MET categories) (minutes)
timeFrame: 6 weeks
measure: Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
timeFrame: 6 weeks
measure: Energy intake and dietary macronutrient composition
timeFrame: 6 weeks
measure: Fasting metabolite/hormone/inflammatory profile
timeFrame: 6 weeks
measure: Postprandial metabolites
timeFrame: 6 weeks
measure: Shoulder Pain
timeFrame: 6 weeks
measure: Exercise Self-Efficacy
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Independence
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
affiliation: University of Bath
name: James Bizon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farrow 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.