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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04397250
Other study ID # 20/SW/0051
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2022

Study information

Verified date July 2022
Source University of Bath
Contact James Bilzon
Phone 01225 383174
Email j.bilzon@bath.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High-intensity interval training
Arm-cranking exercise

Locations

Country Name City State
United Kingdom University of Bath Bath

Sponsors (1)

Lead Sponsor Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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