Trial Outcomes & Findings for Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults (NCT NCT04026126)
NCT ID: NCT04026126
Last Updated: 2022-10-17
Results Overview
Systolic and diastolic blood pressure will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor, which incorporates a disposable, single use fingertip cuff.
COMPLETED
NA
15 participants
Blood pressure will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit). As a safety measure only, blood pressure will be monitored during every heat therapy treatment.
2022-10-17
Participant Flow
Participants were recruited primarily through physician referral; as well as IRB-approved flyers posted at the University of Kansas Medical Center, in the community, and through electronic communications via websites and email. The first participant was enrolled on August 29, 2019 and the last was enrolled on June 24, 2021.
Of the 15 enrolled participants, all 15 met inclusion criteria and completed treatment.
Participant milestones
| Measure |
Heat Therapy Treatment
Participants completed 10 heat therapy treatments (hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session) over 14 days.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults
Baseline characteristics by cohort
| Measure |
Heat Therapy Treatment
n=15 Participants
This study will recruit subjects to participate in heat therapy treatment at the University of Kansas Medical Center (KUMC). After pre-screening, informed consent, and enrollment, all subjects will have baseline hemodynamic assessments as well as VO2max measurements. Subjects will complete 10 heat therapy treatments over the course of 14 days. Hemodynamics will be assessed with the use of the Clearsight© fingertip blood pressure cuff. Within 24-48 hours after the last heat therapy experience, hemodynamic assessments and VO2max will be performed. Blood samples will be collected pre- and post intervention and analyzed for levels of nitric oxide mediators, heat shock protein levels and pro-anti-inflammatory markers.
Heat Therapy Treatment: Subjects will undergo 10 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 14 days. Subjects will be immersed up to the shoulder until rectal temperature reacher 38.5 degrees Celsius (approximately 15-20 minutes). Subjects will then remain in the water bath submerged at waist level to maintain between 38.5 to 39.0 degrees Celsius for another 30 minutes. Following hot water immersion, subjects will be monitored for 10 minutes, or until temperature falls below 38.5 degrees Celsius.
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|---|---|
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Age, Continuous
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58.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
|
Weight
|
80.9 kgs
n=5 Participants
|
|
Hypertension
|
3 Participants
n=5 Participants
|
|
Diabetes
|
2 Participants
n=5 Participants
|
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Asthma
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood pressure will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit). As a safety measure only, blood pressure will be monitored during every heat therapy treatment.Systolic and diastolic blood pressure will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor, which incorporates a disposable, single use fingertip cuff.
Outcome measures
| Measure |
Heat Therapy Treatment
n=15 Participants
Participants completed 10 heat therapy treatments (hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session) over 14 days.
|
|---|---|
|
Change in Blood Pressure
Diastolic Pressure
|
0.85 mmHg
Standard Deviation 4.67
|
|
Change in Blood Pressure
Systolic Pressure
|
-2.94 mmHg
Standard Deviation 10.94
|
PRIMARY outcome
Timeframe: Stroke volume will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Stroke volume will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Outcome measures
| Measure |
Heat Therapy Treatment
n=15 Participants
Participants completed 10 heat therapy treatments (hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session) over 14 days.
|
|---|---|
|
Change in Stroke Volume
|
9.02 ml/m2
Standard Deviation 268.54
|
PRIMARY outcome
Timeframe: Stroke volume variation will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Population: We were unable to collect data on SVV and thus data cannot be reported.
Stroke volume variation will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Cardiac index will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Cardiac index will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Outcome measures
| Measure |
Heat Therapy Treatment
n=15 Participants
Participants completed 10 heat therapy treatments (hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session) over 14 days.
|
|---|---|
|
Change in Cardiac Index
|
-0.36 L/min/m^2
Standard Deviation 0.51
|
PRIMARY outcome
Timeframe: Systemic vascular resistance will be assessed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Systemic vascular resistance will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
Outcome measures
| Measure |
Heat Therapy Treatment
n=15 Participants
Participants completed 10 heat therapy treatments (hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session) over 14 days.
|
|---|---|
|
Change in Systemic Vascular Resistance
|
9.02 dynes/seconds/cm-5
Standard Deviation 268.54
|
PRIMARY outcome
Timeframe: VO2max assessment will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Maximum oxygen consumption (VO2max) will be measured using the Bruce Ramp protocol. The Bruce Ramp protocol is a standardized treadmill exercise commonly used in clinical laboratories.
Outcome measures
| Measure |
Heat Therapy Treatment
n=15 Participants
Participants completed 10 heat therapy treatments (hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session) over 14 days.
|
|---|---|
|
Change in Maximum Oxygen Consumption (VO2max)
|
-0.13 ml/kg/minute
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Population: The samples were run for HSP but the data was compromised. The study team were unable to verify study samples and match them to participant IDs. Thus the data was invalid, and there was not enough sample to repeat the analysis.
Serum levels of heat shock proteins (HSP72, HSP25) and the primary heat shock protein transcription factor (HSF1) will be assessed for change post heat therapy treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Population: The samples were run for nitric oxide bioavailability but the data was compromised. The study team were unable to verify study samples and match them to participant IDs. Thus the data was invalid, and there was not enough sample to repeat the analysis.
Nitric oxide (NO) bioavailability will be assessed for change post heat therapy treatment by measuring nitric oxide and endothelial nitric oxide synthase (eNOS).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Blood analyses will be performed at baseline and 24-48 hours after the last heat therapy session (end of study, ~2.5 weeks after first study visit).Population: The samples were run for pro/Anti-inflammatory markers but the data was compromised. The study team were unable to verify study samples and match them to participant IDs. Thus the data was invalid, and there was not enough sample to repeat the analysis.
Pro/anti-inflammatory markers (IL1ra, IL-10, IL-8, IFN, and CRP) will be assessed for change post heat therapy treatment.
Outcome measures
Outcome data not reported
Adverse Events
Heat Therapy Treatment
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