To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis

Study Overview
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Brief Summary
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This study intends to irradiate the acupoints of both lower extremities of hemodialysis patients with far-infrared therapeutic apparatus to explore its effect on foot blood circulation, peripheral artery occlusion disease (PAOD) symptoms and ankle-brachial index (Ankle-Brachial Index, ABI) value.

Detailed Description
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After irradiating the lower extremity acupoints of hemodialysis patients with far-infrared rays, it is expected to improve the blood circulation of the lower extremities of hemodialysis patients, thereby improving the symptoms of indirect claudication and raising the ankle-brachial index to the normal range, and reducing the incidence of peripheral arterial disease in hemodialysis patients. The results of this study can provide an empirical reference for future clinical care.

Official Title
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To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: far-infrared radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Patients diagnosed with chronic renal failure in a hemodialysis unit and receiving hemodialysis for at least three months 2. Willing to participate in interventional treatment with far-infrared radiation 3. Willingness to cooperate with intervention measures and inspection time 4. Receive hemodialysis treatment three times a week Exclusion Criteria: There are contraindications for ABI examination (such as breast cancer lymph node dissection in the past), bilateral upper limb arteriovenous access, etc.), and a double- lumen dialysis venous catheter is placed in the groin Bedridden or unable to walk History of distal amputation, DVT, CABG s/p due to trauma, ischemia or infection Consciously unclear and unable to cooperate Patients with wounds from calf to instep

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The dialysis day was W 1.3.5 as the control group and W 2.4.6 as the experimental group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: far-infrared radiation on foot acupoints<br>experimental group far-infrared radiation on foot acupoints during dialysis,during dialysis,, and the irradiation distance was 20 cm for 40 minutes each time for six months. | Device: far-infrared radiation<br>* far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis<br>|
| No Intervention: The control group received general clinical routine care<br>no far-infrared radiation on foot acupoints | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Edinburgh Claudication Questionnaire and ABI after receiving far-infrared lower extremity acupoint irradiation therapy (investigators ) and general clinical care (participants) change assessed | investigators :receiving far-infrared intervention;participants :general clinical care | intervention 1,2,3 and 6 month change is being assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of basic data and disease characteristics distribution between the two groups | Demographic characteristics include: gender(boy or gril), age, education level, smoking history, presence/absence of exercise, and drinking; disease characteristics include(yes or no): years of dialysis(year), presence/absence of anticoagulant drugs(yes or no); disease history(yes or no): diabetes, hypertension, coronary artery disease disease, cerebrovascular disease The monthly routine inspection items in the hemodialysis room are designed, | two groups before receiving far-infrared intervention (month 0)change is being assessed | 
| To compare the Edinburgh claudication questionnaire and ABI before (month 0) receiving far-infrared lower extremity acupoint irradiation therapy and general clinical care | In this study, used the Chinese version of the Edinburgh Claudication Questionnaire as a screening test for intermittent claudication symptoms; This study intends to use ABI-type equipment for measurement. Because hemodialysis patients have the limitation that the arm on the side of the arteriovenous fistula can not measure blood pressure, the modification is as follows Calculation method: ABI of left foot = systolic pressure of left posterior tibia ÷ systolic pressure of brachial artery without arteriovenous fistula;ABI of right foot is also calculated in the same way | two groups before receiving far-infrared intervention (month 0)change is being assessed, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, peripheral arterial occlusion disease, far-infrared radiation, lower extremity acupoints, ankle-brachial index, Edinburgh claudication questionnair