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Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Heart Diseases Cardiovascular Diseases Endothelial Dysfunction | Behavioral: Heat Therapy Treatment | Not Applicable |
The National Institute of Health recognizes heart failure as a major public health problem with a prevalence of over 5.8 million Americans and 23 million people worldwide. Commonly prescribed medications to treat the symptoms associated with this disease are expensive and many are not covered by major health insurance companies. There is a critical need to develop novel treatment and prevention strategies for heart failure. Emerging research highlights the benefits of heat therapy (HT) on metabolic and cardiovascular disease risk. The Geiger laboratory has demonstrated that in obese rats fed a high- fat diet for 12 weeks, weekly HT restored whole body glucose tolerance and skeletal muscle insulin sensitivity. The first comprehensive investigation of long-term HT in young, sedentary humans resulted in improved endothelial function and hemodynamics that were on par with what is typically observed with exercise training in previously sedentary subjects. The purpose of this pilot study is to determine if the enhanced endothelial arterial distensibility observed with HT translates into improved cardiorespiratory fitness. The following aims are proposed:
Aim 1: To determine if chronic HT results in improvements in cardiovascular function. The study team hypothesizes that repeated HT will result in improvement in hemodynamic variables related to arterial distensibility (blood pressure, stroke volume, stroke volume variation, cardiac index and systemic vascular resistance) and that these changes translate to improved cardiovascular function as measured by VO2max.
Aim 2: To examine potential mechanism(s) of action of HT in cardiovascular function. The study team hypothesizes that HT may exerts its beneficial effects via the effect of heat shock proteins (HSPs) on Nitric Oxide (NO) bioavailability. This will be tested by measuring HSPs, NO mediators and inflammatory markers at baseline and post-intervention. There is rapidly growing interest in the use of HT as a global therapeutic approach and alternative or complementary therapy to exercise training for patients with chronic disease. Study findings would be clinically significant as both men and women with higher cardiorespiratory fitness (as indicated by maximal oxygen consumption, VO2max) are at lower risk for cardiovascular disease.
These studies will be the first to examine the ability of chronic heat therapy to increase cardiorespiratory fitness as measured by maximal oxygen consumption, VO2max. These findings could lead to HT as a simple and effective tool for improving cardiovascular health in a variety of populations, particularly those with exercise limitations and comorbid disease states like type 2 diabetes, dementia and cardiovascular disease.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 14 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults |
| Actual Study Start Date : | August 29, 2019 |
| Estimated Primary Completion Date : | June 1, 2021 |
| Estimated Study Completion Date : | June 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Heat Therapy Treatment
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.
|
Behavioral: 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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- Change in Blood Pressure [ Time Frame: 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.
- Change in Stroke Volume [ Time Frame: 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.
- Change in Stroke Volume Variation [ Time Frame: 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). ]Stroke volume variation will be monitored using the noninvasive Clearsight (Edward Lifesciences, Irvine, CA) monitor incorporates a disposable, single use fingertip cuff.
- Change in Cardiac Index [ Time Frame: 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.
- Change in Systemic Vascular Resistance [ Time Frame: 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.
- Change in Maximum Oxygen Consumption (VO2max) [ Time Frame: 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.
- Change in concentration of Heat Shock Proteins [ Time Frame: 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). ]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.
- Change in concentration of Nitric Oxide [ Time Frame: 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). ]Nitric oxide (NO) bioavailability will be assessed for change post heat therapy treatment by measuring nitric oxide and endothelial nitric oxide synthase (eNOS).
- Change in concentration of Pro/Anti-inflammatory Markers [ Time Frame: 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). ]Pro/anti-inflammatory markers (IL1ra, IL-10, IL-8, IFN, and CRP) will be assessed for change post heat therapy treatment.
| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Exclusion Criteria:
- Current major cardiovascular disease (i.e.: recent myocardial infarction (heart attack), stroke, angina pectoris, high grade coronary vasculopathy or atherosclerosis, severe valvular disease, cardiac dysrhythmia that requires treatment.
- Current treatment with steroids or immunosuppressive agents
- Cancer
- Serious liver disease
- End-stage renal disease
- Judgement by medical provider that heat therapy poses an undue burden or risk
- Women who are pregnant or plan to become pregnant
| Contact: Angie Ballew, DC, MS | 913-945-7420 | aballew@kumc.edu | |
| Contact: Michelle Vitztum, MPH | mvitztum@kumc.edu |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Michelle Vitztum, MPH 913-588-1045 mvitztum@kumc.edu | |
| Principal Investigator: | Paige C Geiger, Ph.D. | University of Kansas Medical Center | |
| Principal Investigator: | Brigid Flynn, MD | University of Kansas Medical Center |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||||||
| First Posted Date ICMJE | July 19, 2019 | ||||||||
| Last Update Posted Date | March 3, 2021 | ||||||||
| Actual Study Start Date ICMJE | August 29, 2019 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults | ||||||||
| Official Title ICMJE | Effects of Passive Heat Therapy on Oxygen Consumption and Cardiovascular Fitness in Adults | ||||||||
| Brief Summary | The purpose of this study is to determine if enhanced endothelial arterial distensibility observed with heat therapy translates into improved cardiorespiratory fitness. The following aims are proposed: Aim 1: to determine if chronic heat therapy results in improvements in cardiovascular function. Aim 2: To examine potential mechanism(s) of action of heat therapy in cardiovascular function. | ||||||||
| Detailed Description |
The National Institute of Health recognizes heart failure as a major public health problem with a prevalence of over 5.8 million Americans and 23 million people worldwide. Commonly prescribed medications to treat the symptoms associated with this disease are expensive and many are not covered by major health insurance companies. There is a critical need to develop novel treatment and prevention strategies for heart failure. Emerging research highlights the benefits of heat therapy (HT) on metabolic and cardiovascular disease risk. The Geiger laboratory has demonstrated that in obese rats fed a high- fat diet for 12 weeks, weekly HT restored whole body glucose tolerance and skeletal muscle insulin sensitivity. The first comprehensive investigation of long-term HT in young, sedentary humans resulted in improved endothelial function and hemodynamics that were on par with what is typically observed with exercise training in previously sedentary subjects. The purpose of this pilot study is to determine if the enhanced endothelial arterial distensibility observed with HT translates into improved cardiorespiratory fitness. The following aims are proposed: Aim 1: To determine if chronic HT results in improvements in cardiovascular function. The study team hypothesizes that repeated HT will result in improvement in hemodynamic variables related to arterial distensibility (blood pressure, stroke volume, stroke volume variation, cardiac index and systemic vascular resistance) and that these changes translate to improved cardiovascular function as measured by VO2max. Aim 2: To examine potential mechanism(s) of action of HT in cardiovascular function. The study team hypothesizes that HT may exerts its beneficial effects via the effect of heat shock proteins (HSPs) on Nitric Oxide (NO) bioavailability. This will be tested by measuring HSPs, NO mediators and inflammatory markers at baseline and post-intervention. There is rapidly growing interest in the use of HT as a global therapeutic approach and alternative or complementary therapy to exercise training for patients with chronic disease. Study findings would be clinically significant as both men and women with higher cardiorespiratory fitness (as indicated by maximal oxygen consumption, VO2max) are at lower risk for cardiovascular disease. These studies will be the first to examine the ability of chronic heat therapy to increase cardiorespiratory fitness as measured by maximal oxygen consumption, VO2max. These findings could lead to HT as a simple and effective tool for improving cardiovascular health in a variety of populations, particularly those with exercise limitations and comorbid disease states like type 2 diabetes, dementia and cardiovascular disease. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: 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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| Study Arms ICMJE | Experimental: Heat Therapy Treatment
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.
Intervention: Behavioral: Heat Therapy Treatment
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
14 | ||||||||
| Original Estimated Enrollment ICMJE |
20 | ||||||||
| Estimated Study Completion Date ICMJE | June 1, 2021 | ||||||||
| Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04026126 | ||||||||
| Other Study ID Numbers ICMJE | STUDY00142890 P20GM103418-19 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Paige Geiger, PhD, University of Kansas Medical Center | ||||||||
| Study Sponsor ICMJE | University of Kansas Medical Center | ||||||||
| Collaborators ICMJE | National Institute of General Medical Sciences (NIGMS) | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Kansas Medical Center | ||||||||
| Verification Date | May 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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