PhototherapyNCT03420391
PBMT on Muscular Performance and Recovery in Different Time-points
A study testing Photobiomodulation Therapy (PBMT) in people with Phototherapy, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Phototherapy
- What is being tested?
- Photobiomodulation Therapy (PBMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 20 May 2019to 19 Jul 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- not athletes or who engage in physical activity at most once a week
- Individuals should not present a history of musculoskeletal injury in the hip and knee regions in the two months prior to the studies
- they should not be using pharmacological agents and / or nutritional supplements
- They must attend 100% of the data collections.
Who cannot join
- Individuals who do not meet the criteria mentioned above or who present musculoskeletal damage during collection were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Photobiomodulation Therapy (PBMT) on Muscular Performance and Recovery in Different Time-points
Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. The aim of this project is to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal muscle recovery in healthy male subjects. This project aim also to validate the concept that simultaneous use of three wavelengths and light sources lead to optimized action independently of time-window between irradiation and the exercise.
Read the detailed description
This is a randomized, triple-blinded, placebo-controlled trial. Sixty healthy untrained male subjects will be randomly allocated to six experimental groups: Placebo, Control, PBMT 5 mins, PBMT 3h, PBMT 6h and PBMT 24 hours. PBMT will be applied precisely two minutes after baseline MVC test. Then, after five minutes, 3, 6 hours or 1 day (24 hours) of PBMT the eccentric exercise protocol will be performed. We will analyze maximum voluntary contraction (MVC), creatine kinase (CK) activity and delayed onset muscle soreness (DOMS). Assessments will be performed at baseline, immediately after (1 minute), 1 hour, 24 and 48 hours after the eccentric exercise protocol.
- Conditions
- Phototherapy
- Being tested
- Photobiomodulation Therapy (PBMT)
- Keywords
- phototherapy, performance, muscular recovery, photobiomodulation therapy, time-window
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation Therapy (PBMT)Device
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)
| Study group | Role | What they receive |
|---|---|---|
| Placebo PBMT | Placebo comparator | Participants will be treated with placebo PBMT in different time-points before the eccentric exercise protocol (5 minutes, 3 hours, 6 hours or 24 hours). Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. Receives: Device: Photobiomodulation Therapy (PBMT) |
| 5 Minutes | Active comparator | Participants will be performed the eccentric exercise protocol 5 minutes after PBMT.
Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. Receives: Device: Photobiomodulation Therapy (PBMT) |
| 3 Hours | Active comparator | 3 hours: Participants will be performed the eccentric exercise protocol 3 hours after PBMT.
Assessments will be performed before at baseline, 1 minute, 1 hour and 24, 48 hours after the end of exercise protocol. Receives: Device: Photobiomodulation Therapy (PBMT) |
| 6 Hours | Active comparator | 6 hours: Participants will be performed the eccentric exercise protocol 6 hours after PBMT.
Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. Receives: Device: Photobiomodulation Therapy (PBMT) |
| 24 hours | Active comparator | 24 hours: Participants will be performed the eccentric exercise protocol 24 hours after PBMT. Assessments will be performed before at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. Receives: Device: Photobiomodulation Therapy (PBMT) |
| Control | No intervention | Participants will not receive intervention. Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque peak / maximum voluntary contraction - MVC
Assessment was performed in the isokinetic dynamometer (System 4, Biodex®, USA)
Measured: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Secondary outcomes (2)
Delayed onset muscle soreness (DOMS)
Assessment was performed through visual analogue scale (VAS). A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher, where "0" corresponds to no pain and 100mm corresponds to the worst pain possible.
Measured: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Biochemical marker of muscle damage
Analysis of Creatine Kinase (CK) levels
Measured: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start20 May 2019
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhototherapyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty participants will be enrolled in the study. Participants will be randomized in six groups: Control: Participants will receive no intervention; Placebo: Participants will receive placebo PBMT; 5 minutes: Participants will perform the eccentric exercise protocol 5 minutes after PBMT. 3 hours: Participants will perform the eccentric exercise protocol 3 hours after PBMT. 6 hours: Participants will perform the eccentric exercise protocol 6 hours after PBMT. 24 hours: Participants will perform the eccentric exercise protocol 24 hours after PBMT. Assessments will be performed at baseline, after 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Bergen
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420391
- Sponsor's protocol ID
- 113553
- Status last verified
- Apr 2020
- First submitted
- 20 Jan 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leal-Junior ECP, de Oliveira MFD, Joensen J, Stausholm MB, Bjordal JM, Tomazoni SS. What is the optimal time-response window for the use of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) for the improvement of exercise performance and recovery, and for how long the effects last? A randomized, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Oct 19;12:64. doi: 10.1186/s13102-020-00214-8. eCollection 2020.
PubMed 33088573
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy (PBMT) on Muscular Performance and Recovery in Different Time-points
- ClinicalTrials.gov ID
- NCT03420391
- Acronym / sponsor ID
- 113553
- Conditions
- Phototherapy
- Keywords
- phototherapy, performance, muscular recovery, photobiomodulation therapy, time-window
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Bergen
- Study start
- 20 May 2019 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 5 Feb 2018 (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.
Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. The aim of this project is to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal muscle recovery in healthy male subjects. This project aim also to validate the concept that simultaneous use of three wavelengths and light sources lead to optimized action independently of time-window between irradiation and the exercise.
Detailed description
This is a randomized, triple-blinded, placebo-controlled trial. Sixty healthy untrained male subjects will be randomly allocated to six experimental groups: Placebo, Control, PBMT 5 mins, PBMT 3h, PBMT 6h and PBMT 24 hours. PBMT will be applied precisely two minutes after baseline MVC test. Then, after five minutes, 3, 6 hours or 1 day (24 hours) of PBMT the eccentric exercise protocol will be performed. We will analyze maximum voluntary contraction (MVC), creatine kinase (CK) activity and delayed onset muscle soreness (DOMS). Assessments will be performed at baseline, immediately after (1 minute), 1 hour, 24 and 48 hours after the eccentric exercise protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- Sixty participants will be enrolled in the study. Participants will be randomized in six groups: Control: Participants will receive no intervention; Placebo: Participants will receive placebo PBMT; 5 minutes: Participants will perform the eccentric exercise protocol 5 minutes after PBMT. 3 hours: Participants will perform the eccentric exercise protocol 3 hours after PBMT. 6 hours: Participants will perform the eccentric exercise protocol 6 hours after PBMT. 24 hours: Participants will perform the eccentric exercise protocol 24 hours after PBMT. Assessments will be performed at baseline, after 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
| Arm | Type | Receives |
|---|---|---|
| Placebo PBMT | Placebo comparator | Device: Photobiomodulation Therapy (PBMT)Participants will be treated with placebo PBMT in different time-points before the eccentric exercise protocol (5 minutes, 3 hours, 6 hours or 24 hours). Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. |
| 5 Minutes | Active comparator | Device: Photobiomodulation Therapy (PBMT)Participants will be performed the eccentric exercise protocol 5 minutes after PBMT. Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. |
| 3 Hours | Active comparator | Device: Photobiomodulation Therapy (PBMT)3 hours: Participants will be performed the eccentric exercise protocol 3 hours after PBMT. Assessments will be performed before at baseline, 1 minute, 1 hour and 24, 48 hours after the end of exercise protocol. |
| 6 Hours | Active comparator | Device: Photobiomodulation Therapy (PBMT)6 hours: Participants will be performed the eccentric exercise protocol 6 hours after PBMT. Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. |
| 24 hours | Active comparator | Device: Photobiomodulation Therapy (PBMT)24 hours: Participants will be performed the eccentric exercise protocol 24 hours after PBMT. Assessments will be performed before at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. |
| Control | No intervention | –Participants will not receive intervention. Assessments will be performed at baseline, 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- not athletes or who engage in physical activity at most once a week
- Individuals should not present a history of musculoskeletal injury in the hip and knee regions in the two months prior to the studies
- they should not be using pharmacological agents and / or nutritional supplements
- They must attend 100% of the data collections.
Key exclusion criteria (1 listed)
- Individuals who do not meet the criteria mentioned above or who present musculoskeletal damage during collection were excluded from the study.
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 |
|---|---|---|
| Photobiomodulation Therapy (PBMT)Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA) | Device | 24 hours, 3 Hours, 5 Minutes, 6 Hours, Placebo PBMT |
Primary outcome
Torque peak / maximum voluntary contraction - MVC
Time frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Assessment was performed in the isokinetic dynamometer (System 4, Biodex®, USA)
2 secondary outcomes
Delayed onset muscle soreness (DOMS)
Time frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Biochemical marker of muscle damage
Time frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
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 28 Apr 2020.
- Derived from this study: PubMed 33088573Leal-Junior ECP, de Oliveira MFD, Joensen J, Stausholm MB, Bjordal JM, Tomazoni SS. What is the optimal time-response window for the use of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) for the improvement of exercise performance and recovery, and for how long the effects last? A randomized, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Oct 19;12:64. doi: 10.1186/s13102-020-00214-8. eCollection 2020.
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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 Photobiomodulation Therapy (PBMT) in people with Phototherapy, run by University of Nove de Julho 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 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: finished, as of the sponsor's last update on 28 Apr 2020. 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?
Torque peak / maximum voluntary contraction - MVC (time frame: 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420391, which also lists 1 linked publication.
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 28 Apr 2020.