Trial Outcomes & Findings for Heat Therapy Versus Exercise Training in Hypertension (NCT NCT03557502)
NCT ID: NCT03557502
Last Updated: 2025-06-04
Results Overview
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.
COMPLETED
NA
44 participants
10 weeks
2025-06-04
Participant Flow
Three enrollees declined to participate after being registered for the clinical trial (assigned a participant number) but before initiating the intervention.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Protocol 1
STARTED
|
21
|
20
|
|
Protocol 1
COMPLETED
|
21
|
20
|
|
Protocol 1
NOT COMPLETED
|
0
|
0
|
|
Protocol 2
STARTED
|
17
|
14
|
|
Protocol 2
COMPLETED
|
15
|
12
|
|
Protocol 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Protocol 2
Withdrawal by Subject
|
1
|
1
|
|
Protocol 2
Met exclusion criteria at Post timepoint
|
1
|
1
|
Baseline Characteristics
Heat Therapy Versus Exercise Training in Hypertension
Baseline characteristics by cohort
| Measure |
Heat Therapy Group
n=21 Participants
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.
|
Aerobic Exercise Group
n=20 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
47.57 years
n=99 Participants
|
47.95 years
n=107 Participants
|
47.76 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 weeksAmbulatory 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.
Outcome measures
| Measure |
Heat Therapy Group
n=21 Participants
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.
|
Aerobic Exercise Group
n=20 Participants
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.
|
|---|---|---|
|
Blood Pressure Reduction: Change in Systolic and Diastolic Ambulatory Blood Pressure (mmHg) After 30 Sessions of Intervention
Change in systolic Ambulatory Blood Pressure
|
-1 mmHg
Interval -4.0 to 3.0
|
0 mmHg
Interval -3.0 to 4.0
|
|
Blood Pressure Reduction: Change in Systolic and Diastolic Ambulatory Blood Pressure (mmHg) After 30 Sessions of Intervention
Change in diastolic Ambulatory Blood Pressure
|
0 mmHg
Interval -3.0 to 2.0
|
1 mmHg
Interval -2.0 to 3.0
|
SECONDARY outcome
Timeframe: 10 weeksCarotid-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.
Outcome measures
| Measure |
Heat Therapy Group
n=21 Participants
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.
|
Aerobic Exercise Group
n=20 Participants
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.
|
|---|---|---|
|
Arterial Stiffness: Change in Carotid-femoral Pulse Wave Velocity (m/s) From Pre (Baseline) to Post (After 30 Sessions of Intervention)
|
-0.0 meters/second
Interval -0.3 to 0.3
|
-0.1 meters/second
Interval -0.4 to 0.2
|
Adverse Events
Heat Therapy Group
Aerobic Exercise Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place