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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: far-infrared radiation

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Huwei, Taiwan, 632
    • National Taiwan University Hospital Yunlin Branch hemodialysis room
  • Huwei, Taiwan
    • National Taiwan University Hospital Yunlin Branch hemodialysis room

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: far-infrared radiation on foot acupoints; 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; far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis
No Intervention: The control group received general clinical routine care; no far-infrared radiation on foot acupoints

What is the study measuring?

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,

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: April 9, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: hemodialysis; far-infrared radiation; ankle-brachial index; peripheral arterial occlusion disease; lower extremity acupoints; Edinburgh claudication questionnair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 202212028DINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No