Finding the Optimal Voluntary Exercise Parameters for Those Living With Quadriplegia

Sponsor
University of Manitoba (Other)
Overall Status
Completed
CT.gov ID
NCT03146728
Collaborator
(none)
46
1
28
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: exercise

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 Design

Study Type:
Observational
Actual Enrollment :
46 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Finding the Optimal Voluntary Exercise Parameters for Generating a Health Benefit in Those Living With Quadriplegia
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
tetraplegia, paraplegia

motor complete spinal cord injured individuals with tetraplegia or paraplegia

Other: exercise
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

Other: exercise
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.

Outcome Measures

Primary Outcome Measures

  1. changes in energy expenditure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Manitoba Winnipeg Manitoba Canada R3E 0T6

Sponsors and Collaborators

  • University of Manitoba

Investigators

  • Principal Investigator: Barbara L Shay, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barbara Shay, Associate Professor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT03146728
Other Study ID Numbers:
  • H2011:323
  • 313540
First Posted:
May 10, 2017
Last Update Posted:
May 10, 2017
Last Verified:
May 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2017