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Behavioural Intervention
Heat Therapy for High Blood Pressure
N/A
Recruiting
Led By Douglas R Seals, PhD
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Premenopausal women must not be pregnant (confirmed by urine pregnancy test)
Aged 50+ years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 7 months
Awards & highlights
Study Summary
This trial will compare the effects of hot water immersion to neutral water immersion on blood pressure and vascular function in adults aged 50 and up.
Who is the study for?
This trial is for adults aged 50 or older with systolic blood pressure between 120-159 mmHg. Participants must be mentally capable of consent, not pregnant, weight stable, and willing to maintain their lifestyle throughout the study. They should be healthy enough for heat exposure but can't join if they have unstable heart conditions, take multiple anti-hypertensive drugs (except one or two), do intense regular exercise, have recent major health changes including surgery or COVID-19.Check my eligibility
What is being tested?
The study tests whether hot water immersion ('heat therapy') versus thermoneutral water immersion over approximately 12 weeks can lower blood pressure and improve vascular function in middle-aged and older adults.See study design
What are the potential side effects?
Potential side effects may include discomfort from prolonged water immersion, skin sensitivity to pool chemicals, dehydration due to heat exposure, dizziness or fainting during temperature changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, confirmed by a test.
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I am 50 years old or older.
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My weight has been stable, changing by no more than 2 kg in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in casual systolic blood pressure from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Secondary outcome measures
Change in 24-hour ambulatory systolic blood pressure from from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Change in brachial artery flow-mediated dilation from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Other outcome measures
Change in carotid artery beta-stiffness index from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Change in carotid-femoral pulse wave velocity from baseline to 2, 4, 6, 8, 10, and 12 weeks of heat therapy, and 4 and 12 weeks of follow-up.
Induced Hyperthermia
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heat therapyExperimental Treatment1 Intervention
Hot water immersion ~3x per week for 12 weeks
Group II: Thermoneutral water immersionPlacebo Group1 Intervention
Thermoneutral water immersion ~3x per week for 12 weeks
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Who is running the clinical trial?
University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,044 Total Patients Enrolled
10 Trials studying Aging
914 Patients Enrolled for Aging
Douglas R Seals, PhDPrincipal InvestigatorUniversity of Colorado, Boulder
7 Previous Clinical Trials
513 Total Patients Enrolled
5 Trials studying Aging
354 Patients Enrolled for Aging
Vienna E Brunt, PhDPrincipal InvestigatorUniversity of Colorado, Boulder
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to be randomly assigned to a treatment group.You have open wounds or skin conditions that could be affected by being in water for a long time, like in a pool.I have atrial fibrillation or flutter.I am healthy enough for heat stress therapy, as confirmed by my doctors.I have not donated blood in the last 2 months.Your blood pressure is between 120 and 159 mmHg when measured casually.You have trouble with getting blood drawn or having an IV placed, and have fainted from getting blood drawn before.I have not had rectal, anal, vaginal, or prostate surgery in the last 3 months.I am not pregnant, confirmed by a test.I have not had any major health changes like surgery or serious illness in the last 3 months.I am 50 years old or older.My weight has been stable, changing by no more than 2 kg in the last 3 months.I can stop taking supplements, anti-inflammatory drugs, and certain prescriptions as required.I am not on high doses of certain meds that affect body heat or blood pressure.I do not have unstable heart conditions like recent heart attacks.I am on 3 or more medications for high blood pressure, excluding beta-blockers.You do intense aerobic exercise more than four times a week for more than 30 minutes each time.Your body mass index (BMI) is higher than 40 kg/m2.I do not have a significant drop in blood pressure when standing up.I am not currently taking anticholinergics, alpha-blockers, or beta-blockers.My blood pressure is between 140-159 mmHg and I'm not taking blood pressure medicine.
Research Study Groups:
This trial has the following groups:- Group 1: Heat therapy
- Group 2: Thermoneutral water immersion
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment opened for this experiment?
"Affirmative. Clinicaltrials.gov records indicate that this trial, which was first created on March 28th 2022, is actively seeking recruits. 150 participants need to be sourced from 1 particular location."
Answered by AI
How expansive is the scope of this research endeavor in terms of patient recruitment?
"Affirmative. Clinicaltrials.gov reports that the enrollment process for this medical study began on March 28th 2022 and was recently updated on October 18th 2022. The team is looking to recruit 150 participants at a single location."
Answered by AI
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