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NCT Number: NCT05822960

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

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Yunlin Branch hemodialysis room, Huwei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

far-infrared radiation

Device

far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis

Primary outcomes

  1. 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

    Time frame: intervention 1,2,3 and 6 month change is being assessed

    investigators :receiving far-infrared intervention;participants :general clinical care

Secondary outcomes

  1. Comparison of basic data and disease characteristics distribution between the two groups

    Time frame: 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,

  2. To compare the "Edinburgh claudication questionnaire" and "ABI" before (month 0) receiving far-infrared lower extremity acupoint irradiation therapy and general clinical care

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Chung Shan Medical University

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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