Physical ExertionNCT02527850
Effect of Low Level Laser Irradiation on Muscle Performance and Recovery
A study testing B-cure laser in people with Physical Exertion, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of this study is to investigated the effect of B-cure laser on muscle performance and recovery after intense exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exertion
- What is being tested?
- B-cure laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Aug 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy physical education students, ages 20-35, light or intermediate skin color
Who cannot join
- musculoskeletal injury to hips or knees in the previous 2 months, use pharmacological agents or nutritional supplements regularly, smokers, physical limitations on completing the exercise tests -
Trial locations and contacts
1 site in 1 country.
About this study
Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of this study is to investigated the effect of B-cure laser on muscle performance and recovery after intense exercise.
- Conditions
- Physical Exertion
- Being tested
- B-cure laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-cure laserDevice
| Study group | Role | What they receive |
|---|---|---|
| treatment with real laser | Experimental | 10 min irradiation with B-cure soft laser on 3 points of quadriceps muscle. Receives: Device: B-cure laser |
| sham laser | Sham comparator | 10 min irradiation with sham B-cure soft laser on 3 points of quadriceps muscle. Receives: Device: B-cure laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in muscle power as indicated in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment
Measured: 1 hour
evaluation of muscle power after induction of muscle fatigue in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExertionStudies 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, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527850
- Sponsor's protocol ID
- 0028-15
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2015
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Irradiation on Muscle Performance and Recovery
- ClinicalTrials.gov ID
- NCT02527850
- Acronym / sponsor ID
- 0028-15
- Conditions
- Physical Exertion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- 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.
Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of this study is to investigated the effect of B-cure laser on muscle performance and recovery after intense exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment with real laser | Experimental | Device: B-cure laser10 min irradiation with B-cure soft laser on 3 points of quadriceps muscle. |
| sham laser | Sham comparator | Device: B-cure laser10 min irradiation with sham B-cure soft laser on 3 points of quadriceps muscle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy physical education students, ages 20-35, light or intermediate skin color
Key exclusion criteria (1 listed)
- musculoskeletal injury to hips or knees in the previous 2 months, use pharmacological agents or nutritional supplements regularly, smokers, physical limitations on completing the exercise tests -
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 |
|---|---|---|
| B-cure laser | Device | sham laser, treatment with real laser |
Primary outcome
improvement in muscle power as indicated in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment
Time frame: 1 hour
evaluation of muscle power after induction of muscle fatigue in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment
Time frame: 2 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-cure laser in people with Physical Exertion, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 21 Aug 2015. 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 Israel. 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?
Contact Sharon Tsuk, Ph.D (97298639235, sharontsuk2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in muscle power as indicated in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 21 Aug 2015.