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Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease.
This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort.
The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.
It is well understood that SCI causes motor paralysis and sensory loss. However, it is the loss of autonomic regulation that confers the greatest morbidity to those living with SCI. Impaired exercise responses, including limited peak HR, oxygen uptake, limited catecholamine related to impaired activation of spinal sympathetic autonomic systems. Depending upon level of injury, and these sub-optimal exercise responses, there are limited exercise training effects which then leads to a calorie excess and related weight gain, cardiovascular, skeletal muscle and metabolic deconditioning that eventually causes obesity, type II diabetes and cardiovascular disease.
These sedentary-related diseases likely result in large part, because of inadequate activation of these tissues with sufficient duration or intensity to result in training effects. Therefore, we are interested in identifying means to improve acute exercise responses, with an ultimate goal of improving training responses and reducing the incidence of and/or trajectory of developing these sedentary-related diseases in individuals with SCI.
TSES has recently emerged as a potential therapeutic method to improve exercise responses. In case studies it has been shown to increase peak responses and time to fatigue during arm ergometry exercise tests.
This study is designed as a prospective, single-center, randomized controlled trial to examine whether and how TSES might alter exercise responses in two groups of people with SCI (tetraplegia and paraplegia) and a reference control group from the general population. The study is designed to assess within individual and between-group responses for a variety of outcome measures during peak and steady-state exercise tests. Study visits occur over several weeks for each participant, according to each person's time and convenience availability.
Outcomes are assessed during exercise with and without TSES in the following 4 experimental conditions:
The primary hypothesis is that TSES will improve a variety of exercise outcomes under different experimental testing conditions and that those with tetraplegia will benefit most.
The results of this study are expected to contribute to whether and how TSES might alter acute exercise responses in those living with SCI.
The results of this study are expected to contribute to the evidence base regarding the effectiveness of TSES to alter peak and steady-state exercise responses in people with SCI and may support its integration into standard exercise training or competitive sport protocols for individuals with SCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper body exercise in participants with tetraplegia | Other | TSES during peak and steady state exercise in those with tetraplegia |
|
| Upper body exercise in participants with paraplegia | Other | TSES during peak and steady state exercise in those with paraplegia |
|
| Upper body exercise in reference control participants | Other | TSES during peak and steady state exercise in reference controls |
|
| Rhythmic lower limb neuromuscular electrical stimulation evoked exercise | Other | Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise? |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous spinal electrical stimulation (TSES) | Other | TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen uptake | Oxygen uptake, in mL/min | During individual study visits lasting between 1 and 2.5 hours |
| Perceived Exertion | Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard. | Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours |
| Time to fatigue during incremental exercise tests to fatigue | Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds. | Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours. |
| Heart rate | Heart rate, beats per minute | During exercise testing study visits, lasting between 1 and 3 hours |
| Power output | Watts | During exercise in study visits lasting 1 to 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle tissue oxygen saturation levels | Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage. | Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristine C Cowley, PhD | Contact | +1 204-789-3305 | kristine.cowley@umanitoba.ca | |
| Rodrigo Villar, PhD | Contact | +1-204-474-8590 | rodrigo.villar@umanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kristine Cowley, Phd | University of Manitoba | Principal Investigator |
| Rodrigo Villar, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Recruiting | Winnipeg | Manitoba | R3E 0J9 | Canada |
To maintain participant confidentiality
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D013124 | Spinal Injuries |
| D009043 | Motor Activity |
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Participants will be assigned to one of two groups (tetraplegia or paraplegia) depending upon AIS assessment and then crossover testing will occur with or without TSES during tests of peak incremental exercise or steady-state exercise responses.
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| D014947 | Wounds and Injuries |
| D019567 | Back Injuries |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |