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
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJuly 29, 2022
July 1, 2022
2.2 years
May 17, 2020
July 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (18)
Body mass
6 weeks
Waist and hip circumference
6 weeks
Total body fat percentage
6 weeks
Total Fat Mass
6 weeks
Total Fat-Free Mass
6 weeks
- +13 more secondary outcomes
Study Arms (2)
High-intensity interval training
EXPERIMENTALParticipants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week.
Control
NO INTERVENTIONParticipants will be asked to continue their habitual lifestyle
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bath
Bath, BA2 7AY, United Kingdom
Related Publications (1)
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.
PMID: 33600014DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Bizon
University of Bath
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 17, 2020
First Posted
May 21, 2020
Study Start
October 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
July 29, 2022
Record last verified: 2022-07