Acute Effect of Photobiomodulation Therapy on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis: a Crossover Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Maximal isometric muscle strength of the quadriceps
研究概览
简要总结
Chronic kidney disease (CKD) consists of kidney damage and progressive and irreversible loss of kidney function. The aim of this study is to evaluate the acute effect of different doses of photobiomodulation therapy on quadriceps isometric muscle strength, pain and muscle fatigue of lower limbs and to establish the ideal dose for patients with CKD on hemodialysis. Patients will be submitted to application of photobiomodulation therapy in the quadriceps muscle. Immediately after, the maximum isometric strength test of the quadriceps will be performed.
详细描述
Chronic kidney disease (CKD) consists of kidney damage and progressive and irreversible loss of kidney function. In the most advanced stage of the disease the patients require hemodialysis (HD) and present alterations such as: sarcopenia, cardiovascular disorders, increased systemic inflammation, muscle weakness and fatigue. These factors negatively affect the individual's functionality, impacting the increase in hospitalization and mortality rates. Photobiomodulation (FBM) has shown positive results in different populations on improving performance during exercise, reducing fatigue and markers of muscle damage. The aim of this study is to evaluate the acute effect of FBM therapy on quadriceps muscle strength, pain and muscle fatigue in patients with CKD on HD and to establish the ideal therapeutic dose. Patients will be submitted to application of four applications with different doses of FBM (30J, 60J, 90J and placebo) in the quadriceps muscle, in random order and one week interval between them for washout. Patients and evaluators will be blinded to the intervention protocol. The following assessments will be performed prior to FBM: subjective perception of exertion (by modified Borg scale), muscle fatigue (by analysis of blood lactate) and pain perception (by numeric pain scale). After the FBM application, the maximum isometric strength test of the quadriceps will be performed by dynamometry. Immediately after performing the strength test, all assessments will be repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD on HD for a period ≥ 3 months;
- •Age between 18-80 years old;
- •Patients of both sexes;
- •Dialysis with a weekly frequency of 3 times/week;
- •Adequate urea clearance rate (Kt/V ≥ 1.2 or URR ≥65%).
排除标准
- •Cognitive dysfunction that prevents the performance of the assessments, as well as inability to understand and sign the informed consent form;
- •Epidermal lesions at the site of application of photobiomodulation therapy;
- •Patients with recent stroke sequelae (three months);
- •Recent acute myocardial infarction (two months);
- •Uncontrolled hypertension (SBP>230 mmHg and DBP>120 mmHg);
- •HF grade IV according to the New York Heart Association or decompensated;
- •Unstable angina;
- •Peripheral vascular changes in lower limbs such as deep venous thrombosis;
- •Disabling osteoarticular or musculoskeletal disease;
- •Uncontrolled diabetes (blood glucose > 300mg/dL);
- •Febrile state and/or infectious disease;
- •Systemic lupus erythematosus;
- •Patients undergoing cancer treatment.
结局指标
主要结局
Maximal isometric muscle strength of the quadriceps
时间窗: Immediately after the aplication of photobiomodulation therapy.
Maximal isometric muscle strength of the quadriceps will be assessed by dynamometry.
次要结局
- Muscle pain of lower limbs(Baseline and immediately after the dynamometry.)
- Fatigue(Baseline, immediately after dynamometry, at 3 and 6 minutes.)
研究者
Jociane Schardong
Doctor
Federal University of Health Science of Porto Alegre