Transcutaneous Laser Therapy in Chronic Kidney Disease

Официальное название

The Effects of Transcutaneous Laser Therapy in Chronic Kidney Disease

Обзор

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.

Вмешательства

• Устройство Laser
  60-minute 635 nm red laser intervention 3 times per week for 8 weeks
• Устройство Red Light
  60-minute red light sham intervention three times per week for 8 weeks

Первичные конечные точки

• Basic data [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Weight [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Height [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Body Mass Index [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Blood pressure and heart rate [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Blood parameters [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Handgrip strength [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Knee extensor strength [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• Sit-to-stand test [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]
• 2-minute step test [Срок оценки: laser intervention: baseline, 4 weeks, and 8 weeks; red light intervention: baseline, 4 weeks, and 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06855992 · B-BR-113-066-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗