We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397250
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
James Bilzon, University of Bath

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Paraplegia Behavioral: High-intensity interval training Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fasting insulin [ Time Frame: 6 weeks ]
    Serum insulin concentration

  2. Peak aerobic capacity [ Time Frame: 6 weeks ]
    Measured using a incremental ramp protocol on a arm crank ergometer

  3. Peak power output [ Time Frame: 6 weeks ]
    Maximum power output achieved during peak aerobic capacity test


Secondary Outcome Measures :
  1. Body mass [ Time Frame: 6 weeks ]
    Measured using electronic wheelchair scales

  2. Waist and hip circumference [ Time Frame: 6 weeks ]
    Measured using a non-metallic tape

  3. Total body fat percentage [ Time Frame: 6 weeks ]
    Measured using duel-energy x-ray absorptiometry

  4. Total Fat Mass [ Time Frame: 6 weeks ]
    Measured using duel-energy x-ray absorptiometry

  5. Total Fat-Free Mass [ Time Frame: 6 weeks ]
    Measured using duel-energy x-ray absorptiometry

  6. Visceral Adipose Tissue [ Time Frame: 6 weeks ]
    Measured using duel-energy x-ray absorptiometry

  7. Systolic and diastolic blood pressure [ Time Frame: 6 weeks ]
    Measuring using a automated sphygmomanometer

  8. Resting metabolic rate [ Time Frame: 6 weeks ]
    Measured using indirect calorimetry

  9. Time spent in different physical activity intensities (MET categories) (minutes) [ Time Frame: 6 weeks ]
    Time spent in different physical activity intensities across 7-days (MET categories) (minutes)

  10. Energy expended in different physical activity intensities (MET categories) (kJ or kcal) [ Time Frame: 6 weeks ]
    Energy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)

  11. Energy intake and dietary macronutrient composition [ Time Frame: 6 weeks ]
    Estimated using a 7-day weighed food diary

  12. Fasting metabolite/hormone/inflammatory profile [ Time Frame: 6 weeks ]
    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

  13. Postprandial metabolites [ Time Frame: 6 weeks ]
    Assessment of blood glucose and insulin

  14. Shoulder Pain [ Time Frame: 6 weeks ]
    Measured using a validated questionnaire

  15. Exercise Self-Efficacy [ Time Frame: 6 weeks ]
    Measuring using a validated questionnaire

  16. Health-related quality of life [ Time Frame: 6 weeks ]
    Measured using a validated questionnaire

  17. Fatigue [ Time Frame: 6 weeks ]
    Measured using a validated questionnaire

  18. Independence [ Time Frame: 6 weeks ]
    Measured using a validated questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397250


Contacts
Layout table for location contacts
Contact: James Bilzon 01225 383174 j.bilzon@bath.ac.uk

Locations
Layout table for location information
United Kingdom
University of Bath Recruiting
Bath, United Kingdom, BA2 7AY
Contact: Matthew Farrow       m.t.farrow@bath.ac.uk   
Sponsors and Collaborators
University of Bath
Investigators
Layout table for investigator information
Principal Investigator: James Bizon University of Bath
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: James Bilzon, Professor, University of Bath
ClinicalTrials.gov Identifier: NCT04397250    
Other Study ID Numbers: 20/SW/0051
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Bilzon, University of Bath:
high-intensity interval training
cardiometabolic health
Additional relevant MeSH terms:
Layout table for MeSH terms
Paraplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases