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

NCT05881772 | Completed DMC

• 1 other identifier: Laser_HD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic; Renal Dialysis

Keywords

Low-Level Light Therapy; Renal Insufficiency, Chronic; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Maximal isometric muscle strength of the quadriceps

  Maximal isometric muscle strength of the quadriceps will be assessed by dynamometry.

  Immediately after the aplication of photobiomodulation therapy.

Secondary Outcomes (3)

• Muscle pain of lower limbs

  Baseline and immediately after the dynamometry.

• Fatigue

  Baseline and immediately after the dynamometry.

• Fatigue

  Baseline, immediately after dynamometry, at 3 and 6 minutes.

Study Arms (4)

Experimental 1

ACTIVE COMPARATOR

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.

Other: Photobiomodulation

Experimental 2

ACTIVE COMPARATOR

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.

Other: Photobiomodulation

Experimental 3

ACTIVE COMPARATOR

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.

Other: Photobiomodulation

Placebo group

PLACEBO COMPARATOR

The placebo treatment will be performed with the equipment HTM® (model Fluence Maxx, São Paulo, Brazil) turned off.

Other: Photobiomodulation

Interventions

Photobiomodulation OTHER

It will be applied a dose 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). For application, the patient will be positioned in a sitting position and the treatment will be performed with the fixed probe in contact with the skin at an angle of 90º, using the continuous emission mode. The therapy will be applied to the quadriceps muscle, bilaterally.

Also known as: Low level laser therapy

Experimental 1; Experimental 2; Experimental 3; Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Jociane Schardong, PhD

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)