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Heat Therapy Versus Exercise Training in Hypertension

Primary Purpose

Hypertension, Cardiovascular Diseases, Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heat Therapy Group
Aerobic Exercise Group
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Stage 1 hypertension, Arterial Stiffness

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of OregonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heat Therapy Group

Aerobic Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood Pressure Reduction
A reduction in blood pressure following 30 sessions of intervention

Secondary Outcome Measures

Arterial Stiffness
A reduction in arterial pulse wave velocity
Sympathetic Outflow
A reduction in muscle sympathetic outflow

Full Information

First Posted
June 4, 2018
Last Updated
August 31, 2023
Sponsor
University of Oregon
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03557502
Brief Title
Heat Therapy Versus Exercise Training in Hypertension
Official Title
Heat Therapy Versus Exercise Training in Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases, Arterial Hypertension
Keywords
Stage 1 hypertension, Arterial Stiffness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel study design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heat Therapy Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic Exercise Group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Heat Therapy Group
Intervention Description
30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Group
Intervention Description
30 sessions of aerobic exercise training for 45 minutes at 60% of VO2peak
Primary Outcome Measure Information:
Title
Blood Pressure Reduction
Description
A reduction in blood pressure following 30 sessions of intervention
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Arterial Stiffness
Description
A reduction in arterial pulse wave velocity
Time Frame
10 weeks
Title
Sympathetic Outflow
Description
A reduction in muscle sympathetic outflow
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher T Minson, PhD
Phone
541-953-2231
Email
minson@uoregon.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John R Halliwill, PhD
Phone
541-600-4337
Email
halliwil@uoregon.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher T Minson, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher T Minson, PhD
Phone
541-632-4151
Email
minson@uoregon.edu
First Name & Middle Initial & Last Name & Degree
John R Halliwill, PhD
Phone
541-600-4337
Email
halliwil@uoregon.edu
First Name & Middle Initial & Last Name & Degree
John R Halliwill, PhD
First Name & Middle Initial & Last Name & Degree
Christopher T Minson, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be placed in Research Electronic Data Capture (REDCap)
IPD Sharing Time Frame
1 year following completion of subject testing
IPD Sharing Access Criteria
Access to REDCap
IPD Sharing URL
http://www.project-redcap.org

Learn more about this trial

Heat Therapy Versus Exercise Training in Hypertension

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