Heat Therapy Versus Exercise Training in Hypertension

Sponsor

University of Oregon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03557502

Collaborator

Oregon Health and Science University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Cardiovascular Diseases Arterial Hypertension	Other: Heat Therapy Group Other: Aerobic Exercise Group	N/A

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 or Stage 1 hypertension. The investigators will evaluate known biomarkers of arterial stiffness and blood vessel health. It is hypothesized that heat therapy will be superior to exercise training on blood pressure reduction.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized parallel study designRandomized parallel study design

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Heat Therapy Versus Exercise Training in Hypertension

Actual Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Heat Therapy Group 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.	Other: Heat Therapy Group 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session
Experimental: Aerobic Exercise Group 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.	Other: Aerobic Exercise Group 30 sessions of aerobic exercise training for 45 minutes at 60% of VO2peak

Arm

Intervention/Treatment

Experimental: Heat Therapy Group

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.

Other: Heat Therapy Group

30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session

Experimental: Aerobic Exercise Group

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.

Other: Aerobic Exercise Group

30 sessions of aerobic exercise training for 45 minutes at 60% of VO2peak

Outcome Measures

Primary Outcome Measures

Blood Pressure Reduction [10 weeks]
A reduction in blood pressure following 30 sessions of intervention

Secondary Outcome Measures

Arterial Stiffness [10 weeks]
A reduction in arterial pulse wave velocity
Sympathetic Outflow [10 weeks]
A reduction in muscle sympathetic outflow

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Systolic Blood Pressure 120 mmHg or greater and less than 140 mmHg or Diastolic Blood Pressure of 80 or greater and less than 80 mmHg.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oregon	Eugene	Oregon	United States	97403

Sponsors and Collaborators

University of Oregon
Oregon Health and Science University

Investigators

Principal Investigator: Christopher T Minson, PhD, University of Oregon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oregon

ClinicalTrials.gov Identifier:

NCT03557502

Other Study ID Numbers:

UOregon

First Posted:

Jun 15, 2018

Last Update Posted:

May 18, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Oregon

Stage 1 hypertension

Arterial Stiffness

Additional relevant MeSH terms:

Hypertension

Cardiovascular Diseases

Study Results

No Results Posted as of May 18, 2021