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Clinical Trials/NCT03557502
NCT03557502CompletedNot Applicable

Heat Therapy Versus Exercise Training in Hypertension

University of Oregon1 site in 1 country44 target enrollmentStarted: December 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
1
Primary Endpoint
Blood Pressure Reduction: Change in Systolic and Diastolic Ambulatory Blood Pressure (mmHg) After 30 Sessions of Intervention

Study Overview

Brief Summary

This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated or Stage 1 hypertension.

Detailed Description

Hypertension accounts for more cardiovascular disease related deaths than any other modifiable risk factor. While exercise training can be effective at reducing blood pressure in some individuals, many people do not respond to exercise training, and many more are unwilling to undergo regular exercise training. Alternative options need to be explored. This is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated blood pressure (hypertension). The investigators will evaluate known biomarkers of cardiovascular health. It is hypothesized that heat therapy will be superior to exercise training on blood pressure reduction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
35 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Systolic Blood Pressure 120 mmHg or greater and less than 180 mmHg or Diastolic Blood Pressure of 80mmHg or greater and less than 120mmHg

Exclusion Criteria

  • •Secondary hypertension; diagnosed cardiovascular disease other than hypertension; taking anti-hypertensive drugs; BMI of 35 or greater; fasting glucose greater than 125 mg/dl; women who are pregnant, nursing, or desiring to become pregnant.

Arms & Interventions

Heat Therapy Group

Experimental

Group will undergo 30 sessions of heat therapy over approximately 10 weeks. Sessions will require subjects to be immersed in hot water for up to 45 minutes per session.

Intervention: Heat Therapy Group (Other)

Aerobic Exercise Group

Experimental

Group will undergo 30 sessions of aerobic exercise training over approximately 10 weeks. Sessions will require subjects to exercise on a cycle ergometer for up to 45 minutes per session.

Intervention: Aerobic Exercise Group (Other)

Outcomes

Primary Outcomes

Blood Pressure Reduction: Change in Systolic and Diastolic Ambulatory Blood Pressure (mmHg) After 30 Sessions of Intervention

Time Frame: 10 weeks

Ambulatory blood pressure (ABP) was measured at baseline (PRE) and after 30 heat therapy or exercise training sessions (POST) over the course of 8-10 weeks. Two individuals performed post-intervention testing after completing only 27 sessions (1 in each group). Participants arrived at the lab and were fitted with an oscillometric blood pressure cuff attached to an ambulatory blood pressure monitor. The monitor was programmed to inflate and assess blood pressure every 20 min during self-reported waking hours and every 60 min during self-reported sleeping hours. Waking and sleeping times and measurement frequency were replicated at POST within each participant. Ambulatory blood pressure data were analyzed as 24-h total for both systolic and diastolic blood pressure. Change was calculated as the value at the POST timepoint minus the value at the PRE timepoint.

Secondary Outcomes

  • Arterial Stiffness: Change in Carotid-femoral Pulse Wave Velocity (m/s) From Pre (Baseline) to Post (After 30 Sessions of Intervention)(10 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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