Finding the Optimal Voluntary Exercise Parameters for Those Living With Quadriplegia

Obesity Clinical Trial

Official title:

Finding the Optimal Voluntary Exercise Parameters for Generating a Health Benefit in Those Living With Quadriplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146728
• Other study ID #: H2011:323
• Secondary ID: 313540
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: May 8, 2017
• Start date: November 2011
• Est. completion date: March 2014

Study information

• Verified date: May 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism
• Obesity
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in energy expenditure	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