Clinical trial NCT06855992: Transcutaneous Laser Therapy in Chronic Kidney Disease
Official title: The Effects of Transcutaneous Laser Therapy in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Keywords: chronic kidney disease
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. Early intervention in CKD, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis.

Transcutaneous venous laser therapy is a non-invasive treatment. Current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. Additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function.

This project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. It also seeks to reduce patients' medical expenses and National Health Insurance costs.


Eligibility criteria: Inclusion Criteria:

* Individuals aged \>20 years diagnosed with chronic kidney disease (CKD) stages 2-5.
* Estimated glomerular filtration rate (eGFR) \< 90 ml/min/1.73m² (lasting for more than three months).
* Willing to provide routine blood test results before, during, and after each phase of the study.

Exclusion Criteria:

* Acute kidney changes within the past three months (e.g., \>30% decline in eGFR), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions.
* Blood pressure exceeding 160 mmHg at the time of participation.
* Severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer.
* Use of photosensitizing medications, pregnancy, or malignant tumors.
* Sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones.
* Individuals with a hierarchical relationship to the study's principal investigator or team members (e.g., those from the same laboratory or having a student-mentor relationship).

Primary outcomes:
measure: Basic data
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Weight
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Height
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Body Mass Index
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Blood pressure and heart rate
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Blood parameters
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Handgrip strength
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Knee extensor strength
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Sit-to-stand test
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: 2-minute step test
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: The Kidney Disease Quality of Life-36 (KDQOL-36)
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
measure: Time up and go test
timeFrame: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Cheng-Feng Lin Professor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng-Kung University Hospital
name: Chien-Yao Sun MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng-Kung University Hospital
name: Wei-Hung Lin MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cheng Kung University
name: Li-Chieh Kuo Professor, PhD
role: PRINCIPAL_INVESTIGATOR
References: