search
Back to results

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

Primary Purpose

Paraplegia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High-intensity interval training
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paraplegia focused on measuring high-intensity interval training, cardiometabolic health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of BathRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High-intensity interval training

Control

Arm Description

Participants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week.

Participants will be asked to continue their habitual lifestyle

Outcomes

Primary Outcome Measures

Fasting insulin
Serum insulin concentration
Peak aerobic capacity
Measured using a incremental ramp protocol on a arm crank ergometer
Peak power output
Maximum power output achieved during peak aerobic capacity test

Secondary Outcome Measures

Body mass
Measured using electronic wheelchair scales
Waist and hip circumference
Measured using a non-metallic tape
Total body fat percentage
Measured using duel-energy x-ray absorptiometry
Total Fat Mass
Measured using duel-energy x-ray absorptiometry
Total Fat-Free Mass
Measured using duel-energy x-ray absorptiometry
Visceral Adipose Tissue
Measured using duel-energy x-ray absorptiometry
Systolic and diastolic blood pressure
Measuring using a automated sphygmomanometer
Resting metabolic rate
Measured using indirect calorimetry
Time spent in different physical activity intensities (MET categories) (minutes)
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)
Energy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)
Energy intake and dietary macronutrient composition
Estimated using a 7-day weighed food diary
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
Postprandial metabolites
Assessment of blood glucose and insulin
Shoulder Pain
Measured using a validated questionnaire
Exercise Self-Efficacy
Measuring using a validated questionnaire
Health-related quality of life
Measured using a validated questionnaire
Fatigue
Measured using a validated questionnaire
Independence
Measured using a validated questionnaire

Full Information

First Posted
May 17, 2020
Last Updated
July 26, 2022
Sponsor
University of Bath
search

1. Study Identification

Unique Protocol Identification Number
NCT04397250
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia
Keywords
high-intensity interval training, cardiometabolic health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training
Arm Type
Experimental
Arm Description
Participants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be asked to continue their habitual lifestyle
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention Description
Arm-cranking exercise
Primary Outcome Measure Information:
Title
Fasting insulin
Description
Serum insulin concentration
Time Frame
6 weeks
Title
Peak aerobic capacity
Description
Measured using a incremental ramp protocol on a arm crank ergometer
Time Frame
6 weeks
Title
Peak power output
Description
Maximum power output achieved during peak aerobic capacity test
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Body mass
Description
Measured using electronic wheelchair scales
Time Frame
6 weeks
Title
Waist and hip circumference
Description
Measured using a non-metallic tape
Time Frame
6 weeks
Title
Total body fat percentage
Description
Measured using duel-energy x-ray absorptiometry
Time Frame
6 weeks
Title
Total Fat Mass
Description
Measured using duel-energy x-ray absorptiometry
Time Frame
6 weeks
Title
Total Fat-Free Mass
Description
Measured using duel-energy x-ray absorptiometry
Time Frame
6 weeks
Title
Visceral Adipose Tissue
Description
Measured using duel-energy x-ray absorptiometry
Time Frame
6 weeks
Title
Systolic and diastolic blood pressure
Description
Measuring using a automated sphygmomanometer
Time Frame
6 weeks
Title
Resting metabolic rate
Description
Measured using indirect calorimetry
Time Frame
6 weeks
Title
Time spent in different physical activity intensities (MET categories) (minutes)
Description
Time spent in different physical activity intensities across 7-days (MET categories) (minutes)
Time Frame
6 weeks
Title
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Description
Energy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)
Time Frame
6 weeks
Title
Energy intake and dietary macronutrient composition
Description
Estimated using a 7-day weighed food diary
Time Frame
6 weeks
Title
Fasting metabolite/hormone/inflammatory profile
Description
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
Time Frame
6 weeks
Title
Postprandial metabolites
Description
Assessment of blood glucose and insulin
Time Frame
6 weeks
Title
Shoulder Pain
Description
Measured using a validated questionnaire
Time Frame
6 weeks
Title
Exercise Self-Efficacy
Description
Measuring using a validated questionnaire
Time Frame
6 weeks
Title
Health-related quality of life
Description
Measured using a validated questionnaire
Time Frame
6 weeks
Title
Fatigue
Description
Measured using a validated questionnaire
Time Frame
6 weeks
Title
Independence
Description
Measured using a validated questionnaire
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Bilzon
Phone
01225 383174
Email
j.bilzon@bath.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Bizon
Organizational Affiliation
University of Bath
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bath
City
Bath
ZIP/Postal Code
BA2 7AY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Farrow
Email
m.t.farrow@bath.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
33600014
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs