Spinal Cord InjuryNCT02115685
Sympathetic-Somatomotor Coupling in Human Spinal Cord Injury
A study testing Treadmill Training in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Significance: The long term objective of this study is to improve physical therapy and fitness programs in people with spinal cord injury. The results of the study will demonstrate the importance of matching blood flow to a muscle with exercise of that same muscle. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Treadmill Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- incomplete SCI
- subjects will be over age 18
- to fit in the apparatus and to assure a mature gait pattern
- at least 6 months post injury, and medically stable with an incomplete lesion between levels T1-T10
- lower extremity motor score of 10 or greater
- presence of intact stretch reflexes, detected clinically
Show all 9Show fewer
- no previous history or evidence of peripheral nerve damage in the lower extremities
- Subjects must be able to step on a treadmill with no more than 40% body weight support.
- Healthy controls will be age and sex matched to the subjects with spinal cord injury.
Who cannot join
- unhealed decubiti,
- bladder or other infection
- severe contracture or osteoporosis
- heterotopic ossification
- cardiac arrhythmia
- inability to give informed consent
- an episode of autonomic dysreflexia in the past year
- use of spasticity or cardiovascular medications (e.g. baclofen)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
Significance: The long term objective of this study is to improve physical therapy and fitness programs in people with spinal cord injury. The results of the study will demonstrate the importance of matching blood flow to a muscle with exercise of that same muscle.
Scientific Objective: The objective of the study is to measure how the body regulates bloodflow to a muscle during exercise. We intend to study these effects by triggering blood flow changes during movement, and measuring bloodflow changes during exercise in people with spinal cord injury. We will also look at the long term effects of different exercise programs on bloodflow during exercise.
Read more
Study Populations: This study will involve people with partial spinal cord injury and age and sex matched controls without injury.
Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) upper body ergometry, 2) treadmill training with exertion level matched to the upper body ergometry and 3) treadmill training with heart rate matched to an initial test of upper body ergometry.
Read the detailed description
The regulation of cardiovascular systems during muscle activity is poorly understood in people with incomplete spinal cord injury (SCI). In the past, disruptions in somatomotor and sympathetic control have been investigated separately in SCI. We propose to investigate the coupling of sympathetic and somatomotor control because it is relevant to exercise training paradigms that are designed to improve somatomotor function or enhance physical fitness. Our approach will be to measure tendon tap reflexes, voluntary muscle activation, and blood flow of the knee (below injury) and elbow (above injury) before and after sympathetic stimuli consisting of cold pressor tests, mental math and an acute bout of exercise. These data will provide information about sympathetic control of blood flow during muscle activity. Plasticity of the sympatheticsomatomotor coupling will also be investigated by making measurements before and after a treadmill training exercise program. These experiments will enable us to address three aims. Aim 1 will be to characterize coupling of sympathetic and somatomotor systems below the level of spinal injury. This aim will examine spinal sympathetic and motor reflexes and their interactions. It will also examine how descending somatomotor coupling is disrupted by the spinal injury. In Aim 2, we will identify changes in the interactions of sympathetic and somatomotor systems above a spinal injury. Because of the injury and the changes that occur below the injury, the sympathetic-somatomotor coupling is also likely to be disrupted in the arm. Aim 3 will then demonstrate plasticity of sympathetic-somatomotor coupling after exercise training. Three different eight week exercise training programs will be tested including 1) treadmill training with exertion level matched to 70-80% of HRR 2)treadmill training with 30-40% HRR. The exercise training will be tested in a randomized crossover study design with one month between exercise training paradigms. We anticipate that there will be plasticity of sympathetic-somatomotor coupling and that the exercise training effects will normalize control of these systems. However, because of the injury, we anticipate that adaptations will differ from non-injured controls.
This study has implications for exercise training in human SCI. The coupling of sympathetic and somatomotor systems is expected to depend on whether exercise targets the upper or lower body. The recovery of function requires both the improvement in the control of movement as well as in the regulation of blood flow to active muscle groups. In addition, this study is important for understanding the potential impact of treadmill exercise training on cardiovascular fitness, a topic of increasing interest in people with limitations to physical activity.
- Conditions
- Spinal Cord Injury
- Being tested
- Treadmill Training
- Keywords
- spinal cord injury, sympathetic nervous system, locomotor training, exercise
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill TrainingOther
Subjects will be randomized to a high intensity and low intensity group. The high intensity group will train at 70-80% of their HRR and the low intensity group will train at 30-40% of their HRR.
| Study group | Role | What they receive |
|---|---|---|
| One day testing | No intervention | Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. |
| Effects of long term training | Experimental | Aim 3 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) treadmill training at high intensity as defined by 70-80% of HRR or 15-17 RPE 2) treadmill training at low intensity as defined by 30-40% of HRR or <13 RPE Receives: Other: Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood flow
Subject will be tested with doppler ultrasonography immediately pre and post sympathetic stressor. Testing sessions will take anywhere between 3-6 hours.
Measured: 6 hours
Secondary outcomes (4)
Graded Treadmill Exercise Test
Graded treadmill exercise test will be tested at multiple intervals pre and post training paradigms.
Measured: 15 months
Heart rate
Heart rate will be tested continuously during sympathetic stressors and at multiple intervals pre and post training paradigms with a Finapres.
Measured: 15 months
Knee torque
Knee torque will be tested with the Biodex both pre and post sympathetic stressors.
Measured: 8 hours
Tendon tap reflexes
Tendon tap reflexes will be tested during one day testing pre and post sympathetic stressors.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Thomas G Hornby, Shirley Ryan AbilityLab
- Investigators
- Brian D Schmidt, MD, Principal investigator, Marquette UniversityGeorge Hornby, PT, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115685
- Sponsor's protocol ID
- R01NS079751
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2014
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.
PubMed 32476619
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic-Somatomotor Coupling in Human Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02115685
- Acronym / sponsor ID
- R01NS079751
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, sympathetic nervous system, locomotor training, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- Apr 2014
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
Significance: The long term objective of this study is to improve physical therapy and fitness programs in people with spinal cord injury. The results of the study will demonstrate the importance of matching blood flow to a muscle with exercise of that same muscle.
Scientific Objective: The objective of the study is to measure how the body regulates bloodflow to a muscle during exercise. We intend to study these effects by triggering blood flow changes during movement, and measuring bloodflow changes during exercise in people with spinal cord injury. We will also look at the long term effects of different exercise programs on bloodflow during exercise.
Study Populations: This study will involve people with partial spinal cord injury and age and sex matched controls without injury.
Specific Aims: Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. Aim 2 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) upper body ergometry, 2) treadmill training with exertion level matched to the upper body ergometry and 3) treadmill training with heart rate matched to an initial test of upper body ergometry.
Detailed description
The regulation of cardiovascular systems during muscle activity is poorly understood in people with incomplete spinal cord injury (SCI). In the past, disruptions in somatomotor and sympathetic control have been investigated separately in SCI. We propose to investigate the coupling of sympathetic and somatomotor control because it is relevant to exercise training paradigms that are designed to improve somatomotor function or enhance physical fitness. Our approach will be to measure tendon tap reflexes, voluntary muscle activation, and blood flow of the knee (below injury) and elbow (above injury) before and after sympathetic stimuli consisting of cold pressor tests, mental math and an acute bout of exercise. These data will provide information about sympathetic control of blood flow during muscle activity. Plasticity of the sympatheticsomatomotor coupling will also be investigated by making measurements before and after a treadmill training exercise program. These experiments will enable us to address three aims. Aim 1 will be to characterize coupling of sympathetic and somatomotor systems below the level of spinal injury. This aim will examine spinal sympathetic and motor reflexes and their interactions. It will also examine how descending somatomotor coupling is disrupted by the spinal injury. In Aim 2, we will identify changes in the interactions of sympathetic and somatomotor systems above a spinal injury. Because of the injury and the changes that occur below the injury, the sympathetic-somatomotor coupling is also likely to be disrupted in the arm. Aim 3 will then demonstrate plasticity of sympathetic-somatomotor coupling after exercise training. Three different eight week exercise training programs will be tested including 1) treadmill training with exertion level matched to 70-80% of HRR 2)treadmill training with 30-40% HRR. The exercise training will be tested in a randomized crossover study design with one month between exercise training paradigms. We anticipate that there will be plasticity of sympathetic-somatomotor coupling and that the exercise training effects will normalize control of these systems. However, because of the injury, we anticipate that adaptations will differ from non-injured controls.
This study has implications for exercise training in human SCI. The coupling of sympathetic and somatomotor systems is expected to depend on whether exercise targets the upper or lower body. The recovery of function requires both the improvement in the control of movement as well as in the regulation of blood flow to active muscle groups. In addition, this study is important for understanding the potential impact of treadmill exercise training on cardiovascular fitness, a topic of increasing interest in people with limitations to physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One day testing | No intervention | –Aim 1 will be to measure bloodflow during exercise of the legs (below the injury). This aim will examine the control of bloodflow and muscle contractions and how it changes after spinal cord injury. |
| Effects of long term training | Experimental | Other: Treadmill TrainingAim 3 will then look at changes in bloodflow during exercise after training. Three different eight week exercise training programs will be tested including 1) treadmill training at high intensity as defined by 70-80% of HRR or 15-17 RPE 2) treadmill training at low intensity as defined by 30-40% of HRR or <13 RPE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- incomplete SCI
- subjects will be over age 18
- to fit in the apparatus and to assure a mature gait pattern
- at least 6 months post injury, and medically stable with an incomplete lesion between levels T1-T10
- lower extremity motor score of 10 or greater
Key exclusion criteria (8 listed)
- unhealed decubiti,
- bladder or other infection
- severe contracture or osteoporosis
- heterotopic ossification
- cardiac arrhythmia
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 |
|---|---|---|
| Treadmill TrainingSubjects will be randomized to a high intensity and low intensity group. The high intensity group will train at 70-80% of their HRR and the low intensity group will train at 30-40% of their HRR. | Other | Effects of long term training |
Primary outcome
Arterial blood flow
Time frame: 6 hours
Subject will be tested with doppler ultrasonography immediately pre and post sympathetic stressor. Testing sessions will take anywhere between 3-6 hours.
4 secondary outcomes
Graded Treadmill Exercise Test
Time frame: 15 months
Heart rate
Time frame: 15 months
Knee torque
Time frame: 8 hours
Tendon tap reflexes
Time frame: 8 hours
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 6 May 2021.
- Derived from this study: PubMed 32476619Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.
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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.
Brian D Schmidt, MD principal investigator
Marquette University
George Hornby, PT, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Training in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
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 9 inclusion and 8 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 6 May 2021. 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 United States. 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?
Arterial blood flow (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115685, which also lists 1 linked publication.
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 6 May 2021.