Heat Therapy for High Blood Pressure

QF
SR
Overseen BySteven Romero, PhD
Age: 65+
Sex: Female
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Diuretics
Stay on Your Current MedsYou can continue your current medications while participating

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how heat therapy might help lower blood pressure in older women with hypertension. Participants will soak their lower legs in warm water several times a week to determine if it controls blood pressure more effectively than medication alone. The trial also aims to assess whether this method improves blood vessel health. Women aged 65-85 with high blood pressure who can communicate in English and manage this home-based treatment may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to investigate a potentially innovative treatment method for managing high blood pressure.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, all participants will receive a fixed dose of chlorthalidone, a diuretic, as part of the study. If you are on three or more antihypertensive agents, you are not eligible for the trial.

What prior data suggests that this heat therapy is safe for older women with hypertension?

Research has shown that heat therapy can safely help lower blood pressure. Studies have found that repeated exposure to heat can significantly reduce blood pressure. For instance, one study discovered that heat therapy lowered daytime systolic blood pressure (the pressure when the heart beats) by about 5 mmHg. Other research supports this, indicating that heat therapy applied to the legs can lower blood pressure and improve blood vessel function in older adults.

These findings suggest that heat therapy is generally well-tolerated, with no major reports of serious side effects. It's important to note that these studies focused on older adults, who often have more health issues. This increases confidence in the safety of heat therapy for this group. However, always talk to a healthcare provider before starting any new treatment.12345

Why are researchers excited about this trial?

Unlike typical treatments for high blood pressure, which often involve medications like ACE inhibitors, beta-blockers, or diuretics, this approach uses lower leg heat therapy. This technique immerses the legs up to the knees in warm water, which may improve blood circulation and help lower blood pressure naturally. Researchers are excited because this non-invasive method could offer a drug-free option with fewer side effects, providing an alternative for those who prefer or need to avoid medication.

What evidence suggests that lower leg heat therapy is effective for high blood pressure?

This trial will compare the effects of lower leg heat therapy with a control treatment. Research has shown that warming the lower legs can help lower blood pressure. One study found that using heat therapy at home for eight weeks reduced the systolic blood pressure and improved blood vessel function. Another study showed that warming the legs increases blood flow and lowers overall blood pressure. By boosting blood flow, heat therapy may help the body control blood pressure more effectively. This method looks promising, especially for older women who need more than just medication to manage their blood pressure.26789

Who Is on the Research Team?

QF

Qi Fu, MD, PhD

Principal Investigator

University of Texas Southwestern Medical Center

SR

Steven Romero, PhD

Principal Investigator

University of North Texas Health Science Center

Are You a Good Fit for This Trial?

This trial is for older women aged 65-85 with high blood pressure, who speak English and can perform home-based heat therapy. It's not suitable for those with severe hypertension, cardiopulmonary disease, kidney disease, diabetes, substance abuse history (except tobacco), current smokers, or those on hormone replacement therapy.

Inclusion Criteria

I am a woman aged 65-85 with high blood pressure.

Exclusion Criteria

I am taking 3 or more medications for high blood pressure.
You are currently smoking cigarettes.
My BMI is 30 or higher, indicating obesity.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 years
1 visit (in-person)

Wash-out

Patients gradually stop taking their own antihypertensive medications and undergo 24-hour ambulatory BP monitoring

1 week

Run-in

Patients are treated with a fixed dose of chlorthalidone and monitored for BP and drug tolerability

2 weeks
Weekly visits (in-person)

Treatment

Participants receive lower leg heat therapy or control treatment with chlorthalidone

8 weeks
4 times per week (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lower leg heat therapy
Trial Overview The study tests if lower leg heat therapy at home can help manage high blood pressure in older women when combined with a diuretic drug. Participants will either use warm water immersion up to the knee or a neutral temperature control while taking medication over eight weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Published Research Related to This Trial

Heating blood to 40-44 degrees C increased femoral vascular resistance in the hindlimb of anesthetized dogs, while heating limb tissue with external hot packs decreased resistance, indicating that tissue temperature has a more significant impact on blood flow than blood temperature.
Combining blood and tissue heating did not change femoral vascular resistance, and neither heating method enhanced the hyperaemic response to exercise, suggesting that limb warming does not improve blood flow during exercise compared to exercise alone.
Effects of selective blood and tissue heating on blood flow in the dog hindlimb.McMeeken, JM., Bell, C.[2019]
In a case study of a 50-year-old woman recovering from aortic dissection, leg bathing at 42°C for 20 minutes significantly reduced her hypertension, demonstrating an effective non-pharmacological intervention.
After three days of leg bathing, her blood pressure improved from an average of 151/94 mmHg at rest to 137/81 mmHg, indicating that thermal therapy can have a beneficial antihypertensive effect post-surgery.
Antihypertensive Effects of Three Days of Leg Bathing on a Patient With Stanford Type A Acute Aortic Dissection After Surgery: A Case Report.Takahashi, Y., Hasegawa, K., Okura, K.[2023]
In a pilot study involving 6 patients with peripheral artery disease (PAD), acute lower leg heating significantly increased blood flow in the popliteal artery, demonstrating a duration-dependent effect after treatment.
The 6-minute walk distance improved by 10% and 12% following 15 and 45 minutes of heating, respectively, indicating that even short heating sessions can enhance exercise capacity in PAD patients.
Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease.Pellinger, TK., Neighbors, CB., Simmons, GH.[2020]

Citations

Leg heat therapy improves perceived physical function but ...A single session of leg heat therapy (HT) has been shown to elicit increases in leg blood flow and reduce blood pressure (BP) and the circulating levels of ...
Home-based heat therapy lowers blood pressure and ...This study determined that 8 wk of home-based lower body heat therapy reduced ambulatory daytime systolic blood pressure and increased flow-mediated dilation.
Development and feasibility testing of a new device for ...This study represents the first step in developing a portable leg heating system for elderly patients with PAD, demonstrating that home-based leg HT is ...
Could heat therapy offer new treatment options for high ...“Bella's study shows for the first time that just heating the lower legs can boost cardiovascular health in older adults, and what's ...
A systematic review of the role of heat therapy for patients ...In this regard, it is clear that limb blood flow is increased dramatically irrespective of heating method. ... Passive heat therapy lowers systolic blood pressure ...
Home-based heat therapy lowers blood pressure and ...Heat therapy reduced ambulatory daytime systolic blood pressure by Δ −5 ± 8 mmHg, but was unchanged for the sham group (Δ 1 ± 6 mmHg; P = 0.04). Likewise, heat ...
Feasibility of unsupervised, home-based leg heat therapy in ...Acute heat exposure in older adults has been shown to lower arterial blood pressure (14, 53), improve macrovascular and skeletal muscle ...
Home-based heat therapy lowers blood pressure and ...To that end, our group and others have demonstrated that acute leg heating reduces arterial blood pressure and improves vascular function in ...
No effect of either heat therapy or aerobic exercise training ...Although limited, these data suggest that heat therapy may be more effective than exercise training for lowering blood pressure. There is a ...
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