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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04736849 -
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
|
N/A | |
Terminated |
NCT00429013 -
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
|
Phase 2 | |
Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
N/A | |
Completed |
NCT05563402 -
"Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"
|
N/A | |
Recruiting |
NCT05432999 -
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury
|
N/A | |
Enrolling by invitation |
NCT02602639 -
Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury
|
N/A | |
Completed |
NCT00385918 -
Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)
|
N/A | |
Terminated |
NCT02412046 -
Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics
|
N/A | |
Completed |
NCT06169969 -
Effect Of Magnetic Therapy In Bladder Dysfunction And Quality Of Life In Paraplegic Patients
|
N/A | |
Recruiting |
NCT01474148 -
A Neuroprosthesis for Seated Posture and Balance
|
N/A | |
Terminated |
NCT03114345 -
Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient
|
N/A | |
Active, not recruiting |
NCT02600910 -
Natural History of Shoulder Pathology in Manual Wheelchair Users
|
||
Completed |
NCT01739023 -
Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCI
|
Phase 1 | |
Terminated |
NCT01498991 -
Spinal Cord Injury Leg Rehabilitation
|
Phase 1/Phase 2 | |
Recruiting |
NCT06072001 -
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
|
Phase 3 | |
Recruiting |
NCT06071949 -
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
|
Phase 3 | |
Completed |
NCT04215081 -
ExoAtlet II For SCI Patients
|
N/A | |
Completed |
NCT04110561 -
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
|
N/A | |
Completed |
NCT00270855 -
Exercise to Reduce Obesity in Spinal Cord Injury
|
N/A | |
Active, not recruiting |
NCT00059553 -
Retraining Walking After Spinal Cord Injury
|
Phase 2/Phase 3 |