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

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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

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.
    


Study Type

Interventional


Primary Outcome

Fasting insulin

Secondary Outcome

 Body mass

Condition

Paraplegia

Intervention

High-intensity interval training

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

32

Start Date

July 1, 2020

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 01225 383174, [email protected]



Administrative Informations


NCT ID

NCT04397250

Organization ID

20/SW/0051


Responsible Party

Principal Investigator

Study Sponsor

University of Bath


Study Sponsor

, , 


Verification Date

May 2020