Spinal cord injury Injury, Occupational Diseases, Poisoning Injury of spinal cord, level unspecified
Conditions
Interventions
Current interventions as of 10/11/2017:
This is a randomised crossover design with two trial conditions that each last 5.5 hours with a minimum washout of at least 6 days between each
Sponsors
University of Bedfordshire
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 10/11/2017: 1. Male and female 2. Aged 18-60 years 3. Not highly active: engaging in less than <300 min per week of moderate-to-vigorous physical activity 4. Have a chronic spinal cord injury (=1 year since injury) 5. Injured at Thoracic level 6 to Sacral Level 5 (mild to low level paraplegia). These individuals have intact sympathetic innervation to the heart and resting blood pressure is typically normal Previous inclusion criteria: 1. Male 2. Aged 18-50 years 3. Physically inactive: engaging in less than <150 min per week of moderate-to-vigorous physical activity 4. Have a chronic spinal cord injury (=1 year since injury) 5. Injured at Thoracic level 6 to Sacral Level 5 (mild to low level paraplegia). These individuals have intact sympathetic innervation to the heart and resting blood pressure is typically normal
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 10/11/2017: 1. Diagnosed diabetes, hypertension, hypotension, renal failure, liver disease, or history of severe cardiovascular complications 2. Body mass index >45 kg/m2 (severe obesity) 3. A history of autonomic dysreflexia 4. Taking glucose-lowering medication 5. Smoking 6. Major illness or other health issues that may limit ability to perform the exercise protocols Previous exclusion criteria: 1. Diagnosed diabetes, hypertension, hypotension, renal failure, liver disease, or history of severe cardiovascular complications 2. Body mass index >45 kg/m2 (severe obesity) 3. A history of autonomic dysreflexia 4. Taking glucose or lipid-lowering medication 5. Smoking 6. Major illness or other health issues that may limit ability to perform the exercise protocols
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 10/11/2017: Postprandial plasma glucose concentration incremental area under the curve, measured with a benchtop analyser from whole blood samples collected at baseline and then regularly during each of the two trial conditions Previous primary outcome measures: Postprandial plasma glucose concentration incremental area under the curve, measured spectrophotometrically from venous blood samples collected at baseline and then hourly during each of the three trial conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 10/11/2017: 1. Incremental area under the curve for postprandial triglycerides, measured with a benchtop analyser from whole blood samples collected at baseline and then regularly during each of the two trial conditions 2. Incremental area under the curve for HDL, with a benchtop analyser from plasma collected at baseline and then regularly during each of the two trial conditions 3. Incremental area under the curve for insulin, measured using an enzyme immunoassay from plasma samples collected at baseline and then regularly during each of the two trial conditions 4. Systolic and diastolic blood pressure, measured using an automated oscillatory blood pressure monitor at baseline and then regularly during each trial Previous secondary outcome measures: 1. Incremental area under the curve for postprandial triglycerides, measured spectrophotometrically from venous blood samples collected at baseline and then hourly during each of the three trial conditions 2. Incremental area under the curve for HDL, measured spectrophotometrically from venous blood samples collected at baseline and then hourly during each of the three trial conditions 3. Incremental area under the curve for insulin, measured using an enzyme immunoassay from venous blood samples collected at baseline and then hourly during each of the three trial conditions 4. Total area under the curve for IL-6, measured using an enzyme immunoassay from venous blood samples collected at baseline and then hourly during each of the three trial conditions 5. Systolic and diastolic blood pressure, measured using an automated oscillatory blood pressure monitor at baseline and then hourly during each trial | — |
Countries
United Kingdom
Outcome results
None listed