Lower leg heat therapy via water immersion up to the knee in a circulated bath (water temperature 42°C, 4 times per week, 45 minutes per session) for 8 weeks.

Lower leg immerse in a thermoneutral water bath (33°C), 4 times per week, 45 minutes per session for 8 weeks.

Essential Hypertension

All subjects in this research project will be women by design. Women between the ages of 65 and 85 years old will be enrolled.

Home-based 8 weeks of lower leg repeated heating.

Lower leg heat therapy

Institute for Exercise and Environmental Medicine

Heat Therapy in Older Hypertensive Women

Chronic Lower Leg Heating for the Treatment of Hypertension in Older Women

24-hour ambulatory blood pressure monitoring will be performed and systolic blood pressure during the awake period before and after treatment will be compared in older women with hypertension.

We will us the microneurographic technique to measure muscle sympathetic nerve activity in all older hypertensive women before and after treatment. Results will be compared between the intervention group and the control group.

We will use the Ultrasound Doppler technique to measure vascular function including arterial stiffness and endothelial function in older hypertension women before and after treatment. Results will be compared between the groups.

The PD/PIs will comply with the NIH policy of data sharing. Our goal is to make all our data available as quickly as possible to the scientific community. The privacy and rights of the participants will be protected. To address this goal, a Data Sharing Committee will be formed, made up of the two PIs and the statistician.
5) Researchers will make written application to the Data Sharing Committee, and once approved, data will be provided via a secure DropBox or ftp site.

University of Texas Southwestern Medical Center

This is a randomized, placebo-controlled study. Older women with hypertension will randomly be assigned to either an intervention group or a control group (1:1 ratio). Patients in the intervention group will be required to perform 8 weeks of home-based lower leg heat therapy via water immersion up to the knee in a circulated bath (water temperature 42°C, 4 times per week, 45 min per session), whereas patients in the control group will immerse their legs in a thermoneutral water bath (33°C) at the same frequency and duration.

The randomization will be programmed with SAS Proc Plan and implemented via a user friendly web-based interface using REDCap. The biostatistician will be responsible for randomization; however, he/she will not have any contact with the patients and will not be involved in outcome measures. All investigators, except the research nurses, will be blinded to the group status of the patient during 8-week treatment and post-treatment testing. The research nurses will not be involved in data analysis and interpretation.

Renal denervation using the Peregrine Catheter for extravascular administration of ethanol

Hypertension

Bilateral denervation of the renal arteries using extravascular administration of neurolytic alcohol

Renal Denervation

The Institute for Exercise and Environmental Medicine

Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation

18F-Fluorodopamine scanning of the kidney

Muscle sympathetic nervous system activity at rest and during autonomic function testing

National Institute of Neurological Disorders and Stroke (NINDS)

Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.

Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.

Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.

Tiotropium

Placebo

Healthy Controls

Total

Sex: Female, Male

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

Body Surface Area (BSA)

Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease.

All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.

COPD Participants

Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.

Baseline Resting Forced Vital Capacity (FVC)

Predicted normal values for vital capacity can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FVC/predicted FVC X 100.

Baseline Resting FVC as Percentage of Predicted Forced Vital Capacity (FVC)

FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.

Baseline Resting Forced Expiratory Volume in 1 Second (FEV_1)

Predicted normal values for Forced Expiratory Volume in 1 second can be calculated online (based on previous research) and depends on age, sex, height, weight and ethnicity. Percentage was calculated by observed FEV_1/predicted FEV_1 X 100.

Baseline Resting FEV_1 as Percentage of Predicted FEV_1

Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Heart rate was measured in the first study period prior to the intervention at resting and at peak exercise states.

Baseline Heart Rate (HR) for All COPD Participants Versus Healthy Control Groups

VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise.

Baseline Peak Exercise Maximal Oxygen Consumption (VO_2)

Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.

Baseline Peak Exercise Cardiac Index (CI)

Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2).

Baseline Peak Exercise Stroke Volume Index (SVI)

Pretreatment Resting Forced Vital Capacity (FVC)

Baseline Resting Cardiac Index (CI)

Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).

Baseline Resting Stroke Volume Index (SVI)

Pretreatment Resting FVC as Percentage of Predicted FVC

Vital capacity is the maximum amount of air a person can expel from the lungs after a maximum inspiration. A person's vital capacity can be measured by a spirometer which can be a wet or regular spirometer. In combination with other physiological measurements, the vital capacity can help make a diagnosis of underlying lung disease. Percentage change = final value - initial value/initial value x 100

Percent Change in Resting FVC Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Pretreatment Resting FEV_1

FEV_1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Percentage change = final value - initial value/initial value x 100

Percent Change in Resting FEV_1 Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.

Pretreatment Resting CI

Cardiac index (CI): A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index. Percentage change = final value - initial value/initial value x 100

Percent Change in Resting CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Pretreatment Resting SVI

Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the BSA (m^2). Percentage change = final value - initial value/initial value x 100

Percent Change in Resting SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Pretreatment Heart Rate (HR) in Tiotropium and Placebo Groups

Heart rate is the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). Percentage change = final value - initial value/initial value x 100

Percent Change in Resting HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Pretreatment Peak Exercise Maximal Oxygen Consumption (VO_2)

VO_2 is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise. Percentage change = final value - initial value/initial value x 100

Percent Change in Peak Exercise VO_2 Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Pretreatment Peak Exercise CI

Percent Change in Peak Exercise CI Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Pretreatment Peak Exercise SVI

Percent Change in Peak Exercise SVI Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Percent Change in Peak Exercise HR Between Pretreatment in First Study Period and Post-treatment in Second Study Period

Baseline (Prior to Intervention)

Intervention

Bruce D. Johnson, PhD

Chronic Obstructive Pulmonary Disease

COPD

Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device.

Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler device.

acetylene/trötthet

Heat Therapy in Older Hypertensive Women

Physiological Study of the Efficacy and Mechanistic Effects of Alcohol Renal Denervation

Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation

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