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

November 9, 2023 updated by: Jociane Schardong, Federal University of Health Science of Porto Alegre

Acute Effect of Photobiomodulation Therapy on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis: a Crossover Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
        • Santa Casa de Misericórdia de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Experimental 1
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
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.
Other Names:
  • Low level laser therapy
Active Comparator: Experimental 2
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
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.
Other Names:
  • Low level laser therapy
Active Comparator: Experimental 3
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
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.
Other Names:
  • Low level laser therapy
Placebo Comparator: Placebo group
The placebo treatment will be performed with the equipment HTM® (model Fluence Maxx, São Paulo, Brazil) turned off.
Other: Photobiomodulation
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.
Other Names:
  • Low level laser therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal isometric muscle strength of the quadriceps
Time Frame: Immediately after the aplication of photobiomodulation therapy.
Maximal isometric muscle strength of the quadriceps will be assessed by dynamometry.
Immediately after the aplication of photobiomodulation therapy.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Baseline, immediately after dynamometry, at 3 and 6 minutes.
Fatigue of lower limbs by blood lactate dosage.
Baseline, immediately after dynamometry, at 3 and 6 minutes.
Muscle pain of lower limbs
Time Frame: 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.
Baseline and immediately after the dynamometry.
Fatigue
Time Frame: Baseline and immediately after the dynamometry.
Fatigue of lower limbs by the modified Borg subjective perceived exertion scale Modified Borg (Borg Scale). Zero means no effort or fatigue and 10 maximum effort or fatigue.
Baseline and immediately after the dynamometry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Health Science of Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jociane Schardong, PhD, Federal University of Health Sciences of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Laser_HD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings