Renal Insufficiency, ChronicNCT05881772
Acute Effect of Photobiomodulation on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis
A study testing Photobiomodulation in people with Renal Insufficiency, Chronic and Renal Dialysis, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Renal Dialysis
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Insufficiency, Chronic, Renal Dialysis
- Being tested
- Photobiomodulation
- Keywords
- Low-Level Light Therapy, Renal Insufficiency, Chronic, Randomized Controlled Trial
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
Also called Low level laser therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Photobiomodulation |
| Placebo group | Placebo comparator | The placebo treatment will be performed with the equipment HTM® (model Fluence Maxx, São Paulo, Brazil) turned off. Receives: Other: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal isometric muscle strength of the quadriceps
Maximal isometric muscle strength of the quadriceps will be assessed by dynamometry.
Measured: Immediately after the aplication of photobiomodulation therapy.
Secondary outcomes (3)
Muscle pain of lower limbs
Muscle pain of lower limbs will be assessed by the numeric pain scale (NPS). Zero means no pain and 10 maximum pain.
Measured: Baseline and immediately after the dynamometry.
Fatigue
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.
Measured: Baseline and immediately after the dynamometry.
Fatigue
Fatigue of lower limbs by blood lactate dosage.
Measured: Baseline, immediately after dynamometry, at 3 and 6 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jun 2023
- Primary completion1 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jociane Schardong, Federal University of Health Science of Porto Alegre
- Investigators
- Jociane Schardong, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881772
- Sponsor's protocol ID
- Laser_HD
- Status last verified
- Nov 2023
- First submitted
- 21 May 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Photobiomodulation Therapy on Quadriceps Muscle Strength in Patients With Chronic Kidney Failure on Hemodialysis: a Crossover Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05881772
- Acronym / sponsor ID
- Laser_HD
- Conditions
- Renal Insufficiency, Chronic, Renal Dialysis
- Keywords
- Low-Level Light Therapy, Renal Insufficiency, Chronic, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Active comparator | Other: PhotobiomodulationIt 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 | Active comparator | Other: PhotobiomodulationIt 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 | Active comparator | Other: PhotobiomodulationIt 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. |
| Placebo group | Placebo comparator | Other: PhotobiomodulationThe placebo treatment will be performed with the equipment HTM® (model Fluence Maxx, São Paulo, Brazil) turned off. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%).
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: Low level laser therapyIt 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 | Experimental 1, Experimental 2, Experimental 3, Placebo group |
Primary outcome
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.
3 secondary outcomes
Muscle pain of lower limbs
Time frame: Baseline and immediately after the dynamometry.
Fatigue
Time frame: Baseline and immediately after the dynamometry.
Fatigue
Time frame: Baseline, immediately after dynamometry, at 3 and 6 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jociane Schardong, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Renal Insufficiency, Chronic and Renal Dialysis, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal isometric muscle strength of the quadriceps (time frame: Immediately after the aplication of photobiomodulation therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.