Acute Effect of Photobiomodulation on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis

Not Applicable

Completed

• Conditions: Renal Dialysis; Renal Insufficiency, Chronic
• Interventions: Other: Photobiomodulation

• Registration Number: NCT05881772
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-21
• Study First Submitted QC: 2023-05-21
• Study First Posted: 2023-05-31
• Study Start: 2023-06-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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%).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo group	Photobiomodulation	The placebo treatment will be performed with the equipment HTM® (model Fluence Maxx, São Paulo, Brazil) turned off.
Experimental 1	Photobiomodulation	It will be applied a dose of 30J (180J per leg) of laser radiation through a cluster with four diodes, wavelength of 830 nm and power of 800mW (200mW/diode), HTM® (model Fluence Maxx, São Paulo, Brazil) on quadriceps muscle.
Experimental 2	Photobiomodulation	It will be applied a dose of 60J (360J per leg) of laser radiation through a cluster with four diodes, wavelength of 830 nm and power of 800mW (200mW/diode), HTM® (model Fluence Maxx, São Paulo, Brazil) on quadriceps muscle.
Experimental 3	Photobiomodulation	It will be applied a dose of 90J (540J per leg) of laser radiation through a cluster with four diodes, wavelength of 830 nm and power of 800mW (200mW/diode), HTM® (model Fluence Maxx, São Paulo, Brazil) on quadriceps muscle.

Primary Outcome Measures

Name	Time	Method
Maximal isometric muscle strength of the quadriceps	Immediately after the aplication of photobiomodulation therapy.	Maximal isometric muscle strength of the quadriceps will be assessed by dynamometry.

Secondary Outcome Measures

Name	Time	Method
Muscle pain of lower limbs	Baseline and immediately after the dynamometry.	Muscle pain of lower limbs will be assessed by the numeric pain scale (NPS). Zero means no pain and 10 maximum pain.
Fatigue	Baseline, immediately after dynamometry, at 3 and 6 minutes.	Fatigue of lower limbs by blood lactate dosage.

Trial Locations

Locations (1)

Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil