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

Paraplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04397250
• Other study ID #: 20/SW/0051
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: University of Bath
• Contact: James Bilzon
• Phone: 01225 383174
• Email: j.bilzon[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia

Intervention

Behavioral:
• High-intensity interval training
Arm-cranking exercise

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting insulin	Serum insulin concentration	6 weeks
Primary	Peak aerobic capacity	Measured using a incremental ramp protocol on a arm crank ergometer	6 weeks
Primary	Peak power output	Maximum power output achieved during peak aerobic capacity test	6 weeks
Secondary	Body mass	Measured using electronic wheelchair scales	6 weeks
Secondary	Waist and hip circumference	Measured using a non-metallic tape	6 weeks
Secondary	Total body fat percentage	Measured using duel-energy x-ray absorptiometry	6 weeks
Secondary	Total Fat Mass	Measured using duel-energy x-ray absorptiometry	6 weeks
Secondary	Total Fat-Free Mass	Measured using duel-energy x-ray absorptiometry	6 weeks
Secondary	Visceral Adipose Tissue	Measured using duel-energy x-ray absorptiometry	6 weeks
Secondary	Systolic and diastolic blood pressure	Measuring using a automated sphygmomanometer	6 weeks
Secondary	Resting metabolic rate	Measured using indirect calorimetry	6 weeks
Secondary	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
Secondary	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
Secondary	Energy intake and dietary macronutrient composition	Estimated using a 7-day weighed food diary	6 weeks
Secondary	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
Secondary	Postprandial metabolites	Assessment of blood glucose and insulin	6 weeks
Secondary	Shoulder Pain	Measured using a validated questionnaire	6 weeks
Secondary	Exercise Self-Efficacy	Measuring using a validated questionnaire	6 weeks
Secondary	Health-related quality of life	Measured using a validated questionnaire	6 weeks
Secondary	Fatigue	Measured using a validated questionnaire	6 weeks
Secondary	Independence	Measured using a validated questionnaire	6 weeks