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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: far-infrared radiation

• Registration Number: NCT05822960
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-20
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-04-09
• Study First Posted: 2023-04-21
• Primary Completion: 2023-08-10
• Study Completion: 2023-08-10
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

1. 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
2. Bedridden or unable to walk
3. History of distal amputation, DVT, CABG s/p due to trauma, ischemia or infection
4. Consciously unclear and unable to cooperate
5. Patients with wounds from calf to instep

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
far-infrared radiation on foot acupoints	far-infrared radiation	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.

Primary Outcome Measures

Name	Time	Method
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	intervention 1,2,3 and 6 month change is being assessed	investigators :receiving far-infrared intervention;participants :general clinical care

Secondary Outcome Measures

Name	Time	Method
Comparison of basic data and disease characteristics distribution between the two groups	two groups before receiving far-infrared intervention (month 0)"change" is being assessed	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,
To compare the "Edinburgh claudication questionnaire" and "ABI" before (month 0) receiving far-infrared lower extremity acupoint irradiation therapy and general clinical care	two groups before receiving far-infrared intervention (month 0)"change" is being assessed,	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

Trial Locations

Locations (1)

National Taiwan University Hospital Yunlin Branch hemodialysis room; 🇨🇳 Huwei, Taiwan