FatigueNCT05344183
Immediate and Short-term Effects of Low-level Laser
A study testing Low-level laser in people with Fatigue and Muscle Injury, run by Universidade Federal do Amapá at 1 site in Brazil.
Trial summary
Athletes experience an exhaustive routine of training, associated with the reduced time of rest, facilitates the appearance of muscle fatigue, which increases the risk of muscle injuries, especially during the execution of the jump. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Muscle Injury
- What is being tested?
- Low-level laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2022to 12 Dec 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Handball and volleyball athletes;
- Age between 18 and 35 years;
- Both sexes;
- Athletes who maintain a training routine for their sport, at least twice a week
Who cannot join
- History of acute injury to the lower limbs (LL) in the last 2 months;
- Occurrence of pain and injury during the study;
- Any change in physical activity routine during the week of assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate and Short-term Effects of Low-level Laser on the Functional Performance of the Lower Limbs of Jumping Athletes
Athletes experience an exhaustive routine of training, associated with the reduced time of rest, facilitates the appearance of muscle fatigue, which increases the risk of muscle injuries, especially during the execution of the jump. Low Level Lasertherapy is a technique that has been increasingly improved due to the physiological effects it provides in the muscle recovery process. However, there is still a lack of studies focused on the use of this technique in functional improvement, especially in jumping sports. Objectives: To evaluate the immediate and short-term effects of low-level laser on the functional performance of lower limbs of jumping athletes and to evaluate the short-term effects of low-level laser on the activation of the gluteus medius and quadriceps muscles. Methods: This is a brief, double-blind, randomized, placebo-controlled clinical trial. Will be recruited 24 handball and volleyball players aged between 18 to 35 years. The primary outcome of our study is functional performance (modified hop test and modified SEBT), and as a secondary outcome (level of electromyographic activity). After the baseline assessments, the athletes will be randomized and allocated into two groups: Intervention Group (IG, n=12) and Control Group (CG, n=12) and submitted to a fatigue protocol, followed by laser therapy or placebo.
- Conditions
- Fatigue, Muscle Injury
- Being tested
- Low-level laser
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laserDevice
A laser will be used in the quadriceps and gluteus medius muscles with the following parameters described for muscle recovery: dose of 40 J for the gluteus medius muscle, 180 J for the quadriceps muscle; power from 50 to 200 mW per diode (for single probes), 10 to 35 mW per diode (for cluster probes). The full power of the device cannot lead to thermal effects; Wavelengths of 950 nm (infrared).
| Study group | Role | What they receive |
|---|---|---|
| Lasertherapy | Experimental | Not described Receives: Device: Low-level laser |
| Sham lasertherapy | Sham comparator | Not described Receives: Device: Low-level laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Performance
For the evaluation of the functional performance, the tests will be used is the horizontal unipedal jump.
Measured: 6 days
Secondary outcomes (1)
Muscle activity
Muscle activations will be collected using a FREEEMG 1000 electromyographic instrument in the quadriceps femoris muscles.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start3 Sep 2022
- Primary completion12 Nov 2023
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Amapá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renan Lima Monteiro, Universidade Federal do Amapá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344183
- Sponsor's protocol ID
- 120422
- Status last verified
- May 2024
- First submitted
- 12 Apr 2022
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Short-term Effects of Low-level Laser on the Functional Performance of the Lower Limbs of Jumping Athletes
- ClinicalTrials.gov ID
- NCT05344183
- Acronym / sponsor ID
- 120422
- Conditions
- Fatigue, Muscle Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal do AmapáUniversity, hospital or other
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 25 Apr 2022 (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.
Athletes experience an exhaustive routine of training, associated with the reduced time of rest, facilitates the appearance of muscle fatigue, which increases the risk of muscle injuries, especially during the execution of the jump. Low Level Lasertherapy is a technique that has been increasingly improved due to the physiological effects it provides in the muscle recovery process. However, there is still a lack of studies focused on the use of this technique in functional improvement, especially in jumping sports. Objectives: To evaluate the immediate and short-term effects of low-level laser on the functional performance of lower limbs of jumping athletes and to evaluate the short-term effects of low-level laser on the activation of the gluteus medius and quadriceps muscles. Methods: This is a brief, double-blind, randomized, placebo-controlled clinical trial. Will be recruited 24 handball and volleyball players aged between 18 to 35 years. The primary outcome of our study is functional performance (modified hop test and modified SEBT), and as a secondary outcome (level of electromyographic activity). After the baseline assessments, the athletes will be randomized and allocated into two groups: Intervention Group (IG, n=12) and Control Group (CG, n=12) and submitted to a fatigue protocol, followed by laser therapy or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lasertherapy | Experimental | Device: Low-level laser |
| Sham lasertherapy | Sham comparator | Device: Low-level laser |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Handball and volleyball athletes;
- Age between 18 and 35 years;
- Both sexes;
- Athletes who maintain a training routine for their sport, at least twice a week
Key exclusion criteria (3 listed)
- History of acute injury to the lower limbs (LL) in the last 2 months;
- Occurrence of pain and injury during the study;
- Any change in physical activity routine during the week of assessments.
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 |
|---|---|---|
| Low-level laserA laser will be used in the quadriceps and gluteus medius muscles with the following parameters described for muscle recovery: dose of 40 J for the gluteus medius muscle, 180 J for the quadriceps muscle; power from 50 to 200 mW per diode (for single probes), 10 to 35 mW per diode (for cluster probes). The full power of the device cannot lead to thermal effects; Wavelengths of 950 nm (infrared). | Device | Lasertherapy, Sham lasertherapy |
Primary outcome
Functional Performance
Time frame: 6 days
For the evaluation of the functional performance, the tests will be used is the horizontal unipedal jump.
1 secondary outcome
Muscle activity
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser in people with Fatigue and Muscle Injury, run by Universidade Federal do Amapá 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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?
Results are not available in the source record.
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?
Functional Performance (time frame: 6 days). 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 16 May 2024.