- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03146728
Finding the Optimal Voluntary Exercise Parameters for Those Living With Quadriplegia
Finding the Optimal Voluntary Exercise Parameters for Generating a Health Benefit in Those Living With Quadriplegia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the absence of successful regeneration treatments to recover normal neurological function after spinal cord injury, there has been a needed focus on research aimed at preventing or minimizing the secondary complications of living with a spinal cord injury (SCI). Approximately 44,000 persons live with traumatic spinal cord injury in Canada, half of which have tetraplegia, with 35 new spinal cord injuries (SCI) per million each year. Persons with spinal cord injury SCI are among the most sedentary on the planet, with a much higher incidence of related diseases, such as obesity, glucose intolerance, diabetes and cardiovascular disease than the able-bodied population. At the same time, information needed to minimize the risk of developing these diseases for those living with spinal cord injury is lacking. For example, specific information regarding resting energy requirements, energy expenditure during exercise, and the volume of exercise required to maintain a healthy body composition and prevent the development of sedentary-related disease in this population is scarce.
In order to maintain weight, and not gain excess body fat, energy intake in food Calories needs to match energy use. In addition to understanding energy use in order to maintain weight balance, exercise is also important for muscular and cardiovascular health. Research to date indicates that the resting energy expenditure of persons with SCI is considerably less than able-bodied persons with the same weight or body mass index. A considerable portion of this reduced resting energy expense is due to the reduced muscle mass after SCI. There are mixed research results regarding whether there are additional reductions in resting energy expenditure, after adjusting for fat free mass, in persons with SCI. Training has been shown to be effective in reducing shoulder pain, improving function, improving physical capacity, reducing hyperinsulinemia, and reducing dyslipidemia in persons with chronic paraplegia.
However, it is less clear if voluntary exercise can have the same beneficial effects for those living with tetraplegia, in part because their peak power output is only one-third to one-half that achieved during arm exercise in those with paraplegia. In addition, it may be very difficult for those with tetraplegia to be able to exercise for a sufficient duration to achieve a sufficient training effect to either maintain a healthy body composition or reduce the risk of developing the sedentary diseases common to this population. This study will provide the exercise-related energy expenditure data to address this question.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R3E 0T6
- University of Manitoba
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- motor complete spinal cord injury
- tetraplegia or paraplegia
- stabile condition
Exclusion Criteria:
- serious overuse injuries of the upper extremities
- known cardiovascular disease
- current pressure ulcers
- morbid obesity
- known thyroid dysfunction
- cognitive impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
tetraplegia, paraplegia
motor complete spinal cord injured individuals with tetraplegia or paraplegia
|
energy expenditure will be measured for each of the participants during different conditions, rest, during exercise with the arm crank height high or low.
Energy expenditure will also be measured during exercise using different modes (arm ergometer, wheelchair and arm-bike).
Results will be compared between rest and exercise and between individuals with SCI and able-bodied.
|
able-bodied
age height and weight matched able bodied
|
energy expenditure will be measured for each of the participants during different conditions, rest, during exercise with the arm crank height high or low.
Energy expenditure will also be measured during exercise using different modes (arm ergometer, wheelchair and arm-bike).
Results will be compared between rest and exercise and between individuals with SCI and able-bodied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in energy expenditure
Time Frame: At baseline, and every minute for three minutes of steady state exercise
|
Study 1 will test if optimizing the height of the arm crank axis during arm cycle ergometry will show a greater mechanical efficiency for those with tetraplegia and lead to a longer duration of sustained rhythmic exercise. Study 2 will determine the energy expenditure while performing different modes and intensities of voluntary exercise in those with tetraplegia (wheeling, arm cycle ergometry and hand-cycling). Study 3: Will determine if periods of reduced core temperature are present and contribute to the reduced basal and resting energy expenditure in those living with tetraplegia. |
At baseline, and every minute for three minutes of steady state exercise
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barbara L Shay, PhD, University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2011:323
- 313540 (Other Grant/Funding Number: CPA-MB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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