Hypertension
Conditions
Keywords
Hypertension, High Blood Pressure
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPrecision Spectra System
Spinal Cord Stimulation
BEHAVIORALExercise Intervention
Standard Exercise
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Men and post-menopausal women between the ages of 40-90 years old 2. Hypertension (defined as BP ≥ 140/90), diagnosed by a physician 3. Ability of the patient to provide consent
Exclusion criteria
1. History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire. 2. History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision) 3. 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. 4. History of spinal fusion or laminectomy at L3 or above 5. Current prescription opioid usage 6. Contraindication to MRI 7. At physician discretion which will be documented on the case report form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exercise Pressor Reflex From Baseline | 2 years | Change in blood pressure during exercise. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants This is a cross-over study. All participants are pooled at baseline. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Did Not Meet Inclusion Criteria | 0 | 3 |
| Period 1 | Lost to Follow-up | 0 | 1 |
| Period 2 | Did Not Meet Inclusion Criteria | 3 | 0 |
| Period 2 | Lost to Follow-up | 1 | 0 |
| Period 2 | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 62.6 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 5 |
| other Total, other adverse events | 0 / 1 | 0 / 5 |
| serious Total, serious adverse events | 0 / 1 | 0 / 5 |
Outcome results
Primary
Change in Exercise Pressor Reflex From Baseline
Change in blood pressure during exercise.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Stimulation | Change in Exercise Pressor Reflex From Baseline | 8.67 mmHG | — |
| Exercise Intervention | Change in Exercise Pressor Reflex From Baseline | 16.29 mmHG | Standard Error 1.82 |