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To investigate the exercise blood pressure response during a lower-extremity dynamic exercise in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and men with hypertension.
This is a single center study conducted at the University of Minnesota, enrolling up to forty subjects (30 men and 30 post-menopausal women). Subjects will be a assigned to one of the two study arms, (Dynamic Exercise or Spinal Cord Stimulation) and then crossover to the other arm after the initial assignment is complete. However is the screening MRI determines the subject is not a candidate for spinal cord stimulation, then they will be assigned to the Dynamic Exercise arm only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation | Experimental | Boston Scientific Precision Spectra System |
|
| Exercise Intervention | Other | If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Spectra System | Device | Spinal Cord Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Pressor Reflex From Baseline | Change in blood pressure during exercise. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire.
History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision)
Currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation.
Please contact study staff for information regarding your eligibility.
History of spinal fusion or laminectomy at L3 or above
Current prescription opioid usage
Contraindication to MRI
At physician discretion which will be documented on the case report form.
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| Name | Affiliation | Role |
|---|---|---|
| Manda Keller-Ross, PhD, DPT | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States | ||
| University of Minnesota |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation | Boston Scientific Precision Spectra System Precision Spectra System: Spinal Cord Stimulation |
| FG001 | Exercise Intervention | If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm Exercise Intervention: Standard Exercise |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
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Only participants who completed the study are included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is a cross-over study. All participants are pooled at baseline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Exercise Pressor Reflex From Baseline | Change in blood pressure during exercise. | Posted | Mean | Standard Error | mmHG | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Cord Stimulation | Boston Scientific Precision Spectra System Precision Spectra System: Spinal Cord Stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manda Keller-Ross | University of Minnesota | 612-625-3175 | kell0529@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 27, 2018 | Aug 25, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2018 | Aug 25, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Exercise Intervention |
| Behavioral |
Standard Exercise |
|
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Exercise Intervention | If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm Exercise Intervention: Standard Exercise | 0 | 5 | 0 | 5 | 0 | 5 |
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