MetabolismNCT03146728
Finding the Optimal Voluntary Exercise Parameters for Those Living With Quadriplegia
An observational study of Metabolism and Obesity, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Obesity, Spinal Cord Injury
- What is being tested?
- exercise
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- motor complete spinal cord injury
- tetraplegia or paraplegia
- stabile condition
Who cannot join
- serious overuse injuries of the upper extremities
- known cardiovascular disease
- current pressure ulcers
- morbid obesity
- known thyroid dysfunction
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finding the Optimal Voluntary Exercise Parameters for Generating a Health Benefit in Those Living With Quadriplegia
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.
Read the 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.
- Conditions
- Metabolism, Obesity, Spinal Cord Injury
- Being tested
- exercise
- Medical subject headings
- Obesity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| tetraplegia, paraplegia | motor complete spinal cord injured individuals with tetraplegia or paraplegia Receives: Other: exercise | |
| able-bodied | age height and weight matched able bodied Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, and every minute for three minutes of steady state exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startNov 2011
- Primary completionSep 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Shay, University of Manitoba
- Investigators
- Barbara L Shay, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146728
- Sponsor's protocol ID
- H2011:323
- Other IDs
- 313540
- Status last verified
- May 2017
- First submitted
- 14 Jun 2013
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the Optimal Voluntary Exercise Parameters for Generating a Health Benefit in Those Living With Quadriplegia
- ClinicalTrials.gov ID
- NCT03146728
- Acronym / sponsor ID
- H2011:323
- Conditions
- Metabolism, Obesity, Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tetraplegia, paraplegia | – | Other: exercisemotor complete spinal cord injured individuals with tetraplegia or paraplegia |
| able-bodied | – | Other: exerciseage height and weight matched able bodied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- motor complete spinal cord injury
- tetraplegia or paraplegia
- stabile condition
Key exclusion criteria (6 listed)
- serious overuse injuries of the upper extremities
- known cardiovascular disease
- current pressure ulcers
- morbid obesity
- known thyroid dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseenergy 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. | Other | able-bodied, tetraplegia, paraplegia |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara L Shay, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolism and Obesity, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in energy expenditure (time frame: At baseline, and every minute for three minutes of steady state exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.