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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat Therapy Group | Other | 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Stiffness: Change in Carotid-femoral Pulse Wave Velocity (m/s) From Pre (Baseline) to Post (After 30 Sessions of Intervention) | Carotid-femoral pulse wave velocity (m/s) was measured as a marker of arterial stiffness using a pressure transducing tonometer over the carotid artery and an inflated leg cuff to detect the femoral artery pulse waveform using air displacement 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). Change was calculated as the value at the POST timepoint minus the value at the PRE timepoint. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher T Minson, PhD | University of Oregon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oregon | Eugene | Oregon | 97403 | United States |
De-identified data will be placed in Research Electronic Data Capture (REDCap)
1 year following completion of subject testing
Access to REDCap
Protocol 2 participants consisted of a subset of participants from Protocol 1 (i.e. Participants were only eligible for Protocol 2 if they participated in Protocol 1). Not all participants who participated in Protocol 1 were qualified or interested to participate in Protocol 2.
Three enrollees declined to participate after being registered for the clinical trial (assigned a participant number) but before initiating the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Heat Therapy Group: 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session |
| FG001 | 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. Aerobic Exercise Group: 30 sessions of aerobic exercise training for 45 minutes at 60% of VO2peak |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protocol 1 |
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| Protocol 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Heat Therapy Group: 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mmHg | 10 weeks |
|
The average intervention duration for both aerobic exercise and heat therapy was 10 weeks, although the range was 8-13 weeks and 8-16 weeks, respectively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Heat Therapy Group: 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Minson | University of Oregon | 541-953-2231 | minson@uoregon.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2023 | Mar 20, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2024 | Mar 20, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2024 | Mar 28, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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Randomized parallel study design
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| Aerobic Exercise Group | Other | 30 sessions of aerobic exercise training for 45 minutes at 60% of VO2peak |
|
| 10 weeks |
| NOT COMPLETED |
|
|
| 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. Aerobic Exercise Group: 30 sessions of aerobic exercise training consisting of a 5-minute warm-up of seated upright cycling at 30% VO2 peak, followed by 40 minutes of cycling at 60% VO2 peak, then a 5-minute cool down at 30% VO2 peak. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. Heat Therapy Group: 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session. |
| OG001 | 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. Aerobic Exercise Group: 30 sessions of aerobic exercise training consisting of a 5-minute warm-up of seated upright cycling at 30% VO2 peak, followed by 40 minutes of cycling at 60% VO2 peak, then a 5-minute cool down at 30% VO2 peak. |
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| Secondary | Arterial Stiffness: Change in Carotid-femoral Pulse Wave Velocity (m/s) From Pre (Baseline) to Post (After 30 Sessions of Intervention) | Carotid-femoral pulse wave velocity (m/s) was measured as a marker of arterial stiffness using a pressure transducing tonometer over the carotid artery and an inflated leg cuff to detect the femoral artery pulse waveform using air displacement 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). Change was calculated as the value at the POST timepoint minus the value at the PRE timepoint. | Posted | Mean | 95% Confidence Interval | meters/second | 10 weeks |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. Aerobic Exercise Group: 30 sessions of aerobic exercise training consisting of a 5-minute warm-up of seated upright cycling at 30% VO2 peak, followed by 40 minutes of cycling at 60% VO2 peak, then a 5-minute cool down at 30% VO2 peak. | 0 | 20 | 0 | 20 | 0 | 20 |
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