search
Back to results

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

Primary Purpose

Renal Insufficiency, Chronic, Renal Dialysis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic focused on measuring Low-Level Light Therapy, Renal Insufficiency, Chronic, Randomized Controlled Trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Experimental 1

    Experimental 2

    Experimental 3

    Placebo group

    Arm Description

    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.

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Muscle pain of lower limbs
    Muscle pain of lower limbs will be assessed by the numeric pain scale.
    Fatigue
    Fatigue of lower limbs by the modified Borg subjective perceived exertion scale. Modified Borg.
    Fatigue
    Fatigue of lower limbs by blood lactate dosage.

    Full Information

    First Posted
    May 21, 2023
    Last Updated
    May 21, 2023
    Sponsor
    Federal University of Health Science of Porto Alegre
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05881772
    Brief Title
    Acute Effect of Photobiomodulation on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis
    Official Title
    Acute Effect of Photobiomodulation Therapy on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis: a Crossover Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Health Science of Porto Alegre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency, Chronic, Renal Dialysis
    Keywords
    Low-Level Light Therapy, Renal Insufficiency, Chronic, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental 1
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Experimental 2
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Experimental 3
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo treatment will be performed with the equipment HTM® (model Fluence Maxx, São Paulo, Brazil) turned off.
    Intervention Type
    Other
    Intervention Name(s)
    Photobiomodulation
    Other Intervention Name(s)
    Low level laser therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Maximal isometric muscle strength of the quadriceps
    Description
    Maximal isometric muscle strength of the quadriceps will be assessed by dynamometry.
    Time Frame
    Immediately after the aplication of photobiomodulation therapy.
    Secondary Outcome Measure Information:
    Title
    Muscle pain of lower limbs
    Description
    Muscle pain of lower limbs will be assessed by the numeric pain scale.
    Time Frame
    Baseline and immediately after the dynamometry.
    Title
    Fatigue
    Description
    Fatigue of lower limbs by the modified Borg subjective perceived exertion scale. Modified Borg.
    Time Frame
    Baseline and immediately after the dynamometry.
    Title
    Fatigue
    Description
    Fatigue of lower limbs by blood lactate dosage.
    Time Frame
    Baseline, immediately after dynamometry, at 3 and 6 minutes.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jociane Schardong, PhD
    Phone
    +55 55 981348114
    Email
    joci_fisioufsm@yahoo.com.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jociane Schardong, PhD
    Organizational Affiliation
    Federal University of Health Sciences of Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs