Clinical trial NCT03146728: Finding the Optimal Voluntary Exercise Parameters for Those Living With Quadriplegia
Official title: Finding the Optimal Voluntary Exercise Parameters for Generating a Health Benefit in Those Living With Quadriplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism
Obesity
Spinal Cord Injury
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will consist of 7 persons living with tetraplegia in addition to 7 persons living with paraplegia to act as controls for study 1. Participants will have sustained a motor-complete spinal cord injury at least 6 months previous. Able-bodied participants are matched for age, height and weight.

Brief summary: There are over 44,000 persons living with spinal cord injury (SCI) in Canada, who face substantial challenges in maintaining a healthy body composition after injury. As a result, obesity, diabetes and cardiovascular disease are prevalent in this population. Guidelines indicating that twice weekly 20-minute sessions of exercise (plus resistance training) will increase physical fitness in those with SCI have been recently published. However, no SCI-specific guidelines indicating the volume of exercise to reduce the risk of developing obesity-related diseases exist. Longitudinal studies indicate that a weekly exercise-related energy expenditure of 2000 - 2500 Calories is correlated with the least likelihood of cardiovascular disease in the able-bodied population. There is little information regarding energy expenditure (EE) for activities carried out by persons with SCI, with less available for persons with tetraplegia. Once known, this EE data can be used to develop exercise interventions to determine the volume of voluntary exercise required to reduce obesity and risk factors for diabetes and cardiovascular disease in those living with tetraplegia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in energy expenditure
timeFrame: At baseline, and every minute for three minutes of steady state exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Barbara L Shay, PhD
role: PRINCIPAL_INVESTIGATOR
References: