Heating Treatments for Peripheral Artery Disease
(EPR Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Milton S. Hershey Medical Center
Disqualifiers: Pregnant, Decisional impairment, CAD, others
Trial Summary
What is the purpose of this trial?The study objectives of this projects are to examine the hypothesis that the sympathetic and blood pressure responses to exercise will be attenuated during and after heat exposure in patients with peripheral artery disease, via altering the sensitivity of the muscle afferent receptors.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment for Peripheral Artery Disease?
Research shows that heat therapy, such as heated-water exercise and home-based leg heating, can improve walking distance and reduce blood pressure in patients with Peripheral Artery Disease (PAD). These therapies are well-tolerated and can enhance exercise tolerance and quality of life, making them a promising alternative or complement to traditional exercise programs.
12345Is heat therapy safe for humans with peripheral artery disease?
Heat therapy, such as hot-water immersion and heated-water exercise, has been well tolerated and shown to be safe in studies involving patients with peripheral artery disease. Participants adhered well to the treatment, and no significant safety concerns were reported.
23678How does the No Heat Treatment for Peripheral Artery Disease differ from other treatments?
The No Heat Treatment, or Standard Exercise Protocol, for Peripheral Artery Disease (PAD) involves supervised exercise without additional heating elements. Unlike heat therapies that use hot-water immersion or heated garments to improve blood flow and reduce symptoms, this approach focuses solely on traditional exercise to enhance walking ability and cardiovascular health.
12378Eligibility Criteria
This trial is for men and women aged 21-85 with Peripheral Artery Disease (PAD), specifically those who can consent, speak English, have an ankle-brachial index below 0.9 without rest pain, and are generally healthy otherwise. It excludes pregnant or nursing women, individuals under 21 or with decisional impairments, prisoners, and those with other chronic diseases or recent severe cardiac events.Inclusion Criteria
I have been diagnosed with peripheral artery disease (PAD).
Any race or ethnicity
I do not have any current severe illnesses.
+6 more
Exclusion Criteria
Pregnant or nursing women
I have difficulty making decisions due to a mental condition.
I have had heart issues like unstable angina or a heart attack in the last 6 months.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo various heating interventions followed by treadmill walking using the Gardner protocol. BP, HR, and NIRS are continuously measured.
3-4 hours per visit
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if heating methods like a heating suit or warm water immersion before exercise can reduce the sympathetic nervous system's response in PAD patients. The hypothesis suggests that heat may make muscle receptors less sensitive to stress from exercise.
10Treatment groups
Experimental Treatment
Placebo Group
Group I: PAD warm bathExperimental Treatment2 Interventions
Subjects will take a warm bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group II: PAD lower limb warm water immersionExperimental Treatment2 Interventions
Subjects will place their lower legs in warm water. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group III: PAD heating suitExperimental Treatment2 Interventions
Whole body heating with the suit will be performed. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group IV: Healthy subjects warm bathExperimental Treatment2 Interventions
Subjects will take a warm bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group V: Healthy subjects lower limb immersionExperimental Treatment2 Interventions
Subjects will place their lower legs in warm water. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group VI: Healthy subjects heat suitExperimental Treatment2 Interventions
Whole body heating with the suit will be performed. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group VII: Healthy subjects without heatingPlacebo Group2 Interventions
Subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group VIII: Healthy subjects neutral bathPlacebo Group2 Interventions
Subjects will take a neutral bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group IX: PAD without heatingPlacebo Group2 Interventions
Subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Group X: PAD neutral bathPlacebo Group2 Interventions
Subjects will take a neutral bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Milton S. Hershey Medical CenterHershey, PA
Loading ...
Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
References
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).
Heat therapy vs. supervised exercise therapy for peripheral arterial disease: a 12-wk randomized, controlled trial. [2020]Peripheral arterial disease (PAD) is characterized by lower limb atherosclerosis impairing blood supply and causing walking-induced leg pain or claudication. Adherence to traditional exercise training programs is poor due to these symptoms despite exercise being a mainstay of conservative treatment. Heat therapy improves many cardiovascular health outcomes, so this study tested if this was a viable alternative cardiovascular therapy for PAD patients. Volunteers with PAD were randomized to 12 wk of heat (n = 11; mean age 76 ± 8 yr, BMI 28.7 ± 3.5 kg/m2, 4 females) or exercise (n = 11; 74 ± 10 yr, 28.5 ± 6.8 kg/m2, 3 females). Heat involved spa bathing at ∼39°C, 3-5 days/wk for ≤30 min, followed by ≤30 min of callisthenics. Exercise involved ≤90 min of supervised walking and gym-based exercise, 1-2 days/wk. Following the interventions, total walking distance during a 6-min walk test increased (from ∼350 m) by 41 m (95% CI: [13, 69], P = 0.006) regardless of group, and pain-free walking distance increased (from ∼170 m) by 43 m ([22, 63], P < 0.001). Systolic blood pressure was reduced more following heat (-7 mmHg, [-4, -10], P < 0.001) than following exercise (-3 mmHg, [0, -6], P = 0.078), and diastolic and mean arterial pressure decreased by 4 mmHg in both groups (P = 0.002). There were no significant changes in blood volume, ankle-brachial index, or measures of vascular health. There were no differences in the improvement in functional or blood pressure outcomes between heat and exercise in individuals with PAD. NEW & NOTEWORTHY Heat therapy via hot-water immersion and supervised exercise both improved walking distance and resting blood pressure in peripheral arterial disease (PAD) patients over 12 wk. Adherence to heat therapy was excellent, and the heat intervention was well tolerated. The results of the current study indicate that heat therapy can improve functional ability and has potential as an effective cardiovascular conditioning tool for individuals with PAD.
Effects of heated water-based versus land-based exercise training on vascular function in individuals with peripheral artery disease. [2022]Peripheral artery disease (PAD) is an atherosclerotic disease that is associated with poor vascular function, walking impairment, and reduced quality of life. Land-based exercise therapy (LBET) is frequently recommended to improve walking and reduce symptoms. Recently, evidence has suggested that heated-water exercise therapy (HWET) is an effective intervention for PAD. However, the efficacy of LBET versus HWET in PAD patients had not been elucidated. Therefore, we sought to compare effects of LBET with HWET on cardiovascular function, exercise tolerance, physical function, and body composition in PAD patients. PAD patients (n = 53) were recruited and randomly assigned to a LBET group (n = 25) or HWET group (n = 28). The LBET group performed treadmill walking, whereas the HWET group performed walking in heated water for 12 wk. Leg (legPWV) and brachial-to-ankle arterial stiffness (baPWV), blood pressure (BP), ankle-brachial index (ABI), 6-min walking distance (6MWD), claudication onset time (COT), physical function, and body composition were assessed before and after 12 wk. There were significant group-by-time interactions (P < 0.05) for legPWV, BP, 6MWD, COT, body composition, and resting metabolic rate (RMR). Both groups significantly reduced (P < 0.05) legPWV, BP, and body fat percentage, and HWET measures were significantly lower than LBET measures. Both groups significantly increased 6MWD, COT, and RMR, and HWET group measures were significantly greater than LBET measures. A time effect was noted for baPWV reduction in both groups (P < 0.05). These results suggest that both LBET and HWET improve cardiovascular function, exercise tolerance, and body composition, and HWET showed considerably greater improvements compared with LBET in patients with PAD.NEW & NOTEWORTHY The results of this study reveal for the first time that although land-based exercise therapy is effective for reducing arterial stiffness and blood pressure in patients with peripheral artery disease (PAD), heated-water exercise therapy demonstrates greater benefits on vascular function. The greater improvements in muscular strength, time to onset of claudication, and exercise tolerance after heated-water exercise therapy may have clinical implications for improving quality of life in patients with PAD. The heated-water exercise therapy intervention demonstrated relatively higher exercise training adherence (∼88%) compared with the land-based exercise intervention (∼81%).
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.
Exercise Rehabilitation for Peripheral Artery Disease: A REVIEW. [2019]To summarize evidence regarding exercise therapy for people with lower extremity peripheral artery disease (PAD).
Heat therapy improves body composition and muscle function but does not affect capillary or collateral growth in a model of obesity and hindlimb ischemia. [2022]Heat therapy (HT) has emerged as a potential adjunctive therapy to alleviate the symptoms of peripheral artery disease (PAD), but the mechanisms underlying the positive effects of this treatment modality remain undefined. Using a model of diet-induced obesity (DIO) and ischemia-induced muscle damage, we tested the hypothesis that HT would alter body composition, promote vascular growth and mitochondrial biogenesis, and improve skeletal muscle function. Male DIO C57Bl/6J mice underwent bilateral ligation of the femoral artery and were randomly allocated to receive HT or a control intervention for 30 min daily over 3 wk. When compared with a group of lean, sham-operated animals, ligated DIO mice exhibited increases in body and fat masses, exercise intolerance, and contractile dysfunction of the isolated soleus (SOL) and extensor digitorum longus (EDL) muscles. Repeated HT averted an increase in body mass induced by high-fat feeding due to reduced fat accrual. Fat mass was ∼25% and 29% lower in the HT group relative to controls after 2 and 3 wk of treatment, respectively. Muscle mass relative to body mass and maximal absolute force of the EDL, but not SOL, were higher in animals exposed to HT. There were no group differences in skeletal muscle capillarization, the expression of angiogenic factors, mitochondrial content, and the diameter of the gracilis arteries. These findings indicate that HT reduces diet-induced fat accumulation and rescues skeletal muscle contractile dysfunction. This practical treatment may prove useful for diabetic and obese PAD patients who are unable to undergo conventional exercise regimens.NEW & NOTEWORTHY The epidemic of obesity-related dyslipidemia and diabetes is a central cause of the increasing burden of peripheral artery disease (PAD), but few accessible therapies exist to mitigate the metabolic and functional abnormalities in these patients. We report that daily exposure to heat therapy (HT) in the form of lower-body immersion in water heated to 39 °C for 3 weeks attenuates fat accumulation and weight gain, and improves muscle strength in obese mice with femoral artery occlusion.
Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease. [2021]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 endothelin-1 (ET-1) in patients with symptomatic peripheral artery disease (PAD). We assessed whether 6 wk of supervised leg HT (3 times/wk) with water-circulating trousers perfused with water at 48°C improved 6-min walk distance in individuals with PAD compared with a sham treatment. Secondary outcomes included the assessment of leg vascular function, BP, quality of life, and serum ET-1 and nitrite plus nitrate (NOx) levels. Of 32 PAD patients randomized, 30 [age: 68 ± 8 yr; ankle-brachial index (ABI): 0.6 ± 0.1] completed the 3- and 6-wk follow-ups. Participants completed 98.7% of the treatment sessions. Compared with the sham treatment, exposure to HT did not improve 6-min walk distance, BP, popliteal artery reactive hyperemia, cutaneous microvascular reactivity, resting ABI, or serum NOx levels. The change from baseline to 6 wk in scores of the physical functioning subscale of the 36-item Short Form Health Survey was significantly higher in the HT group (control -6.9 ± 10 vs. HT 6.8 ± 15; 95% confidence interval: 2.5-24.3, P = 0.017). Similarly, the change in ET-1 levels after 6 wk was different between groups, with the HT group experiencing a 0.4 pg/mL decrease (95% confidence interval: -0.8-0.0, P = 0.03). These preliminary results indicate that leg HT may improve perceived physical function in symptomatic PAD patients. Additional, larger studies are needed to confirm these findings and determine the optimal treatment regimen for symptomatic PAD patients.NEW & NOTEWORTHY This is the first sham-controlled study to investigate the effects of leg heat therapy (HT) on walking performance, vascular function, and quality of life in patients with peripheral artery disease (PAD). Adherence to HT was high, and the treatment was well tolerated. Our findings revealed that HT applied with water-circulating trousers evokes a clinically meaningful increase in perceived physical function and reduces the serum concentration of the potent vasoconstrictor endothelin-1 in patients with PAD.
Heat treatment improves the exaggerated exercise pressor reflex in rats with femoral artery occlusion via a reduction in the activity of the P2X receptor pathway. [2021]Label="KEY POINTS">During exercise, the blood pressure (BP) response is exaggerated in peripheral artery disease (PAD). We examined whether heat treatment (HT) has beneficial effects on the exaggerated exercise pressor reflex in PAD rats. With HT (increase in basal muscle temperature of ∼1.5°C for 30 min, twice daily for three continuous days), the amplified BP response to muscle contraction is alleviated in PAD. We demonstrated that HT attenuates the enhancement of the BP response induced by stimulation of P2X in muscle afferent nerves of PAD rats. HT also attenuates the upregulation of the P2X3 and the increase in P2X currents in the muscle afferent neurons of PAD rats. Previous heat exposure plays a beneficial role in modifying the exaggeration of the exercise pressor reflex in PAD and a reduction in the activity of the P2X receptor pathway is probably a part of the mechanism mediating this improvement.