Leg Heat Therapy for Heart Failure
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF.
What data supports the idea that Leg Heat Therapy for Heart Failure is an effective treatment?The available research shows that Leg Heat Therapy can improve sleep quality in patients with chronic heart failure. In one study, patients who received leg thermal therapy reported better sleep quality after three nights of treatment. Additionally, another study on a similar heat therapy method, a steam foot bath, showed improvements in heart function for patients with severe heart failure. These findings suggest that Leg Heat Therapy can be a helpful treatment for heart failure by improving sleep and heart function.2491112
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable medical treatment, which suggests you may need to continue your current medications.
Eligibility Criteria
This trial is for men and women over 18 with heart failure where the heart's main pumping chamber still pumps well (HFpEF). They must have had certain tests showing this condition, like an echocardiogram or elevated NT-pro-BNP levels, and be on stable medications.Inclusion Criteria
I have heart failure with a normal pump function confirmed by tests.
Participant Groups
The study is testing leg heat therapy to see if it improves muscle function and exercise ability in patients with HFpEF. Participants will receive either actual heat therapy or a sham (fake) treatment as a control to compare results.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heat therapyExperimental Treatment1 Intervention
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while in the supine position.
Group II: Sham controlPlacebo Group1 Intervention
Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
IU Health University HospitalIndianapolis, IN
IU Health MethodistIndianapolis, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
Purdue UniversityCollaborator
References
[Circulatory changes in acute sauna hyperthermia after heart transplantation]. [2007]The authors report on the influence of a single sauna-stay of patients following heart transplantation (HTX) during the rehabilitation phase III. Investigations of blood pressure, heart rate, changer in hemodynamics in the small and large vessels in 8 male patients following HTX (medium age: 42 years) showed that sauna-hyperthermia is well tolerated. We watched significant decreases of blood pressure (systolic and diastolic values), an improvement of the microcirculation in the small vessels, an increase of the left ventricular ejection fraction (LVEF) and a decrease of the total peripheric vascular resistance (TPVR). Possibilities and limitations of sauna-therapy for the therapy of risk factors following HTX especially under immunosuppression are discussed. First results are demonstrated.
Heat therapy in the management of heart failure. [2019]Heart failure remains a health care epidemic, and additional complementary therapies beyond pharmaceuticals and devices are needed. Using heat therapy or topical thermal therapy is an ancient therapeutic approach for the treatment of heart failure. Currently, there are several studies reporting salutary effects of heat therapy in patients with heart failure using either dry heat or water immersion therapies. The authors describe an additional theoretic construct using topically applied heat pads that might be a simple and economic approach to affect heat therapy as an adjunct for many patients. Hopefully future studies will continue to explore heat therapy as adjunctive care for heart failure patients.
Easing vasomotor symptoms: Besides HRT, what works? [2019]Prescription HRT is the most effective therapy for vasomotor symptoms, but some patients may find the risks unacceptable. Treatment with lower doses or alternative dosage forms for short periods may reduce risk. Soy isoflavones and black cohosh have a proven ability to reduce hot flashes, but they should not be used when estrogen is contraindicated. Bioidentical HRT may offer no benefits over conventional HRT. Neuroendocrine agents may reduce hot flashes effectively and can be used when estrogen is contraindicated, but these agents may cause significant CNS side effects. Lifestyle modifications are the foundation of vasomotor symptom therapy and are safe to recommend for all women. Clinicians and patients should carefully discuss the expectations for therapy, and the clinician should be prepared to customize the treatment regimen.
[Appendicular thermal therapy for heart failure]. [2011]We preliminarily assessed the utility of a steam foot bath in 4 male patients with dilated cardiomyopathy with refractory chronic congestive heart failure awaiting heart transplantation. Sublingual temperature significantly increased from 36.1 +/- 0.3 to 36.7 +/- 0.2 degrees C (p = 0.01). Blood pressure, heart rate and numbers of ventricular arrhythmia did not differ before and after two weeks of the therapy. Grade of mitral regurgitation tended to decrease (2.0 +/- 1.2 to 1.3 +/- 1.0, p = 0.06), and endothelial function measured by arterial tonometry significantly increased from 1.35 +/- 0.26 to 2.13 +/- 0.26 (p = 0.02). Thus, steam foot bath therapy may be safe and beneficial for the patients with endstage heart failure awaiting heart transplantation.
Effectiveness of group and self-help cognitive behavior therapy in reducing problematic menopausal hot flushes and night sweats (MENOS 2): a randomized controlled trial. [2022]The aim of this study was to examine the effectiveness of group cognitive behavioral therapy (CBT) and guided self-help CBT in reducing hot flush and night sweat (HF/NS) problem rating at 6 and 26 weeks after randomization.
Potential role of gabapentin and extended-release gabapentin in the management of menopausal hot flashes. [2021]About 80% of postmenopausal women experience vasomotor symptoms, such as hot flashes and night sweats - symptoms that are associated with sleep disruption and can lead to fatigue and mood changes. Moreover, hot flashes can be embarrassing for women, causing difficulties at work and in their social lives. Many therapies have been advocated for relief of vasomotor symptoms, but only hormone therapy has been US Food and Drug Administration approved. However, after the Women's Health Initiative Study suggested that there was a correlation between hormone therapy and increased risk for breast cancer and cardiovascular events, many women stopped taking hormone therapy, and many do not want to initiate it. Hormone therapy is also contraindicated in certain women, such as those with a history of hormone-stimulated cancer like breast and uterine cancer. Gabapentin (Neurontin) has shown efficacy in relieving vasomotor symptoms and is used as off-label for this indication. A new extended-release formulation of gabapentin has also shown efficacy in treating hot flashes and improving sleep quality with possibly fewer side effects than regular gabapentin.
Telephone-guided Self-Help Cognitive Behavioural Therapy for menopausal symptoms. [2022]Group and Self-Help forms of Cognitive Behavioural Therapy (CBT) are effective treatment options for women with problematic menopausal hot flushes and night sweats (HF/NS). However, some women are unable to attend face-to-face sessions. This study investigates whether Self-Help CBT for HF/NS is as effective when rolled out to women living at a distance with minimal telephone guidance.
Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure. [2021]Home oxygen therapy (HOT) is commonly used for patients with severe chronic heart failure (CHF) who have intractable breathlessness. There is no trial evidence to support its use.
Three nights leg thermal therapy could improve sleep quality in patients with chronic heart failure. [2018]Sleep quality is often impaired in patients with chronic heart failure (HF), which may worsen their quality of life and even prognosis. Leg thermal therapy (LTT), topical leg warming, has been shown to improve endothelial function, oxidative stress, and cardiac function in patients with HF. However, its short-term influence to sleep quality has not been evaluated in HF patients. Eighteen of 23 patients with stable HF received LTT (15 min of warming at 45 °C and 30 min of insulation) at bedtime for 3 consecutive nights and 5 patients served as control. Subjective sleep quality was evaluated by St. Mary's Hospital Sleep Questionnaire, Oguri-Shirakawa-Azumi Sleep Inventory, and Epworth sleepiness scale, and also objectively evaluated by polysomnography. LTT significantly improved subjective sleep quality indicated by depth of sleep (p
Self-help cognitive behavior therapy for working women with problematic hot flushes and night sweats (MENOS@Work): a multicenter randomized controlled trial. [2022]The aim of the study was to examine the efficacy of an unguided, self-help cognitive behavior therapy (SH-CBT) booklet on hot flush and night sweat (HFNS) problem rating, delivered in a work setting.
Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease. [2020]In this pilot study, we tested the hypothesis that acute lower leg heating (LLH) increases postheating popliteal artery blood flow and 6-minute walk distance in patients with peripheral artery disease (PAD).
Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. [2023]Few noninvasive therapies currently exist to improve functional capacity in people with lower extremity peripheral artery disease (PAD). The goal of the present study was to test the hypothesis that unsupervised, home-based leg heat therapy (HT) using water-circulating trousers perfused with warm water would improve walking performance in patients with PAD. Patients with symptomatic PAD were randomized into either leg HT (n = 18) or a sham treatment (n = 16). Patients were provided with water-circulating trousers and a portable pump and were asked to apply the therapy daily (7 days/wk, 90 min/session) for 8 wk. The primary study outcome was the change from baseline in 6-min walk distance at 8-wk follow-up. Secondary outcomes included the claudication onset-time, peak walking time, peak pulmonary oxygen consumption and peak blood pressure during a graded treadmill test, resting blood pressure, the ankle-brachial index, postocclusive reactive hyperemia in the calf, cutaneous microvascular reactivity, and perceived quality of life. Of the 34 participants randomized, 29 completed the 8-wk follow-up. The change in 6-min walk distance at the 8-wk follow-up was significantly higher (P = 0.029) in the group exposed to HT than in the sham-treated group (Sham: median: -0.9; 25%, 75% percentiles: -5.8, 14.3; HT: median: 21.3; 25%, 75% percentiles: 10.1, 42.4, P = 0.029). There were no significant differences in secondary outcomes between the HT and sham group at 8-wk follow-up. The results of this pilot study indicate that unsupervised, home-based leg HT is safe, well-tolerated, and elicits a clinically meaningful improvement in walking tolerance in patients with symptomatic PAD.NEW & NOTEWORTHY This is the first sham-controlled trial to examine the effects of home-based leg heat therapy (HT) on walking performance in patients with peripheral artery disease (PAD). We demonstrate that unsupervised HT using water-circulating trousers is safe, well-tolerated, and elicits meaningful changes in walking ability in patients with symptomatic PAD. This home-based treatment option is practical, painless, and may be a feasible adjunctive therapy to counteract the decline in lower extremity physical function in patients with PAD.