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

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.

Study Overview

• Status: Recruiting
• Conditions: Paraplegia
• Intervention / Treatment: Behavioral: High-intensity interval training

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Bilzon; Phone Number: 01225 383174; Email: j.bilzon@bath.ac.uk

Study Locations

• United Kingdom
  • Bath, United Kingdom, BA2 7AY
    • Recruiting
    • University of Bath
    • Contact: Matthew Farrow; Email: m.t.farrow@bath.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Arm-cranking exercise
No Intervention: Control; Participants will be asked to continue their habitual lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting insulin	Serum insulin concentration	6 weeks
Peak aerobic capacity	Measured using a incremental ramp protocol on a arm crank ergometer	6 weeks
Peak power output	Maximum power output achieved during peak aerobic capacity test	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Measured using electronic wheelchair scales	6 weeks
Waist and hip circumference	Measured using a non-metallic tape	6 weeks
Total body fat percentage	Measured using duel-energy x-ray absorptiometry	6 weeks
Total Fat Mass	Measured using duel-energy x-ray absorptiometry	6 weeks
Total Fat-Free Mass	Measured using duel-energy x-ray absorptiometry	6 weeks
Visceral Adipose Tissue	Measured using duel-energy x-ray absorptiometry	6 weeks
Systolic and diastolic blood pressure	Measuring using a automated sphygmomanometer	6 weeks
Resting metabolic rate	Measured using indirect calorimetry	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)	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)	6 weeks
Energy intake and dietary macronutrient composition	Estimated using a 7-day weighed food diary	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	6 weeks
Postprandial metabolites	Assessment of blood glucose and insulin	6 weeks
Shoulder Pain	Measured using a validated questionnaire	6 weeks
Exercise Self-Efficacy	Measuring using a validated questionnaire	6 weeks
Health-related quality of life	Measured using a validated questionnaire	6 weeks
Fatigue	Measured using a validated questionnaire	6 weeks
Independence	Measured using a validated questionnaire	6 weeks

Collaborators and Investigators

• Sponsor: University of Bath
• Investigators: Principal Investigator: James Bizon, University of Bath

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: high-intensity interval training; cardiometabolic health
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Paraplegia
• Other Study ID Numbers: 20/SW/0051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No