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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

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
far-infrared radiation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring hemodialysis, peripheral arterial occlusion disease, far-infrared radiation, lower extremity acupoints, ankle-brachial index, Edinburgh claudication questionnair

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University Hospital Yunlin Branch hemodialysis roomRecruiting
  • National Taiwan University Hospital Yunlin Branch hemodialysis roomRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

far-infrared radiation on foot acupoints

The control group received general clinical routine care

Arm Description

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.

no far-infrared radiation on foot acupoints

Outcomes

Primary Outcome Measures

Comparison of the "Edinburgh Claudication Questionnaire" and "ABI" on1, 2, 3, and 6 months after receiving far-infrared lower extremity acupoint irradiation therapy (investigators ) and general clinical care (participants) change is being assessed
investigators :receiving far-infrared intervention;participants :general clinical care

Secondary Outcome Measures

Comparison of basic data and disease characteristics distribution between the two groups
Demographic characteristics include: gender, age, education level, smoking history, presence/absence of exercise, and drinking; disease characteristics include: years of dialysis, presence/absence of anticoagulant drugs; disease history: diabetes, hypertension, coronary artery disease disease, cerebrovascular disease, hyperparathyroidism. 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
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

Full Information

First Posted
March 6, 2023
Last Updated
April 9, 2023
Sponsor
National Taiwan University Hospital
Collaborators
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05822960
Brief Title
To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis
Official Title
To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 7, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
hemodialysis, peripheral arterial occlusion disease, far-infrared radiation, lower extremity acupoints, ankle-brachial index, Edinburgh claudication questionnair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
far-infrared radiation on foot acupoints
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group received general clinical routine care
Arm Type
No Intervention
Arm Description
no far-infrared radiation on foot acupoints
Intervention Type
Device
Intervention Name(s)
far-infrared radiation
Intervention Description
far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis
Primary Outcome Measure Information:
Title
Comparison of the "Edinburgh Claudication Questionnaire" and "ABI" on1, 2, 3, and 6 months after receiving far-infrared lower extremity acupoint irradiation therapy (investigators ) and general clinical care (participants) change is being assessed
Description
investigators :receiving far-infrared intervention;participants :general clinical care
Time Frame
intervention 1,2,3 and 6 month change is being assessed
Secondary Outcome Measure Information:
Title
Comparison of basic data and disease characteristics distribution between the two groups
Description
Demographic characteristics include: gender, age, education level, smoking history, presence/absence of exercise, and drinking; disease characteristics include: years of dialysis, presence/absence of anticoagulant drugs; disease history: diabetes, hypertension, coronary artery disease disease, cerebrovascular disease, hyperparathyroidism. The monthly routine inspection items in the hemodialysis room are designed,
Time Frame
two groups before receiving far-infrared intervention (month 0)"change" is being assessed
Title
To compare the "Edinburgh claudication questionnaire" and "ABI" before (month 0) receiving far-infrared lower extremity acupoint irradiation therapy and general clinical care
Description
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
Time Frame
two groups before receiving far-infrared intervention (month 0)"change" is being assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
We-Yu Kang, University
Phone
0921341289
Email
wqoup1109@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
We-Yu Kang, University
Phone
05-5330002
Ext
575051
Email
Y01424@ylh.gov.tw
Facility Information:
Facility Name
National Taiwan University Hospital Yunlin Branch hemodialysis room
City
Huwei
ZIP/Postal Code
632
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Yu Kang
Phone
0921341289
Email
Y01424@ylh.gov.tw
Facility Name
National Taiwan University Hospital Yunlin Branch hemodialysis room
City
Huwei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
We-Yu Kang, University
Phone
0921341289
Email
wqoup1109@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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