Paraplegia Clinical Trial
Official title:
The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial
Verified date | July 2022 |
Source | University of Bath |
Contact | James Bilzon |
Phone | 01225 383174 |
j.bilzon[@]bath.ac.uk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Bath | Bath |
Lead Sponsor | Collaborator |
---|---|
University of Bath |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fasting insulin | Serum insulin concentration | 6 weeks | |
Primary | Peak aerobic capacity | Measured using a incremental ramp protocol on a arm crank ergometer | 6 weeks | |
Primary | Peak power output | Maximum power output achieved during peak aerobic capacity test | 6 weeks | |
Secondary | Body mass | Measured using electronic wheelchair scales | 6 weeks | |
Secondary | Waist and hip circumference | Measured using a non-metallic tape | 6 weeks | |
Secondary | Total body fat percentage | Measured using duel-energy x-ray absorptiometry | 6 weeks | |
Secondary | Total Fat Mass | Measured using duel-energy x-ray absorptiometry | 6 weeks | |
Secondary | Total Fat-Free Mass | Measured using duel-energy x-ray absorptiometry | 6 weeks | |
Secondary | Visceral Adipose Tissue | Measured using duel-energy x-ray absorptiometry | 6 weeks | |
Secondary | Systolic and diastolic blood pressure | Measuring using a automated sphygmomanometer | 6 weeks | |
Secondary | Resting metabolic rate | Measured using indirect calorimetry | 6 weeks | |
Secondary | Time spent in different physical activity intensities (MET categories) (minutes) | Time spent in different physical activity intensities across 7-days (MET categories) (minutes) | 6 weeks | |
Secondary | 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) | 6 weeks | |
Secondary | Energy intake and dietary macronutrient composition | Estimated using a 7-day weighed food diary | 6 weeks | |
Secondary | 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 | 6 weeks | |
Secondary | Postprandial metabolites | Assessment of blood glucose and insulin | 6 weeks | |
Secondary | Shoulder Pain | Measured using a validated questionnaire | 6 weeks | |
Secondary | Exercise Self-Efficacy | Measuring using a validated questionnaire | 6 weeks | |
Secondary | Health-related quality of life | Measured using a validated questionnaire | 6 weeks | |
Secondary | Fatigue | Measured using a validated questionnaire | 6 weeks | |
Secondary | Independence | Measured using a validated questionnaire | 6 weeks |
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