Heat Therapy Versus Exercise Training in Hypertension

NCT03557502 | Completed Results

• 1 other identifier: UOregon
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Cardiovascular Diseases; Arterial Hypertension

Keywords

Stage 1 hypertension; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

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

  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.

  10 weeks

Secondary Outcomes (1)

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

  10 weeks

Study Arms (2)

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.

Other: Heat Therapy Group

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.

Other: Aerobic Exercise Group

Interventions

Heat Therapy Group OTHER

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

Heat Therapy Group

Aerobic Exercise Group OTHER

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

Aerobic Exercise Group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Dr. Christopher Minson
• Organization: University of Oregon

minson@uoregon.edu

541-953-2231

Study Officials

• Christopher T Minson, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel study design

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: December 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year following completion of subject testing
• Access Criteria: Access to REDCap

Locations

US (1)