Aerobic EnduranceNCT03879226
Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans
A study testing PBMT in people with Aerobic Endurance, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects. However some key aspects, such as the potentially beneficial effects of PBMT during the detraining period still remain unknown. 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
- Aerobic Endurance
- What is being tested?
- 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
- 25 Mar 2019to 25 Aug 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 men;
- Aged from 18 to 35 years;
- Complete at least 80% of the study procedures will be included in the study.
Who cannot join
- History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
- Become injured during the study;
- Regularly use pharmacological agents and/ or nutritional supplements;
- Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, São Paulo, 01504-001
About this study
In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects. However some key aspects, such as the potentially beneficial effects of PBMT during the detraining period still remain unknown.
Therefore, the aim of this project is to evaluate the effects of PBMT applied before and after aerobic training sessions and during the detraining period.
Read the detailed description
It will be carried out a randomized, triple-blind, placebo-controlled trial.
Seventy-two volunteers will be randomly allocated to four experimental groups:
- PBMT before and after the aerobic training sessions and PBMT during the detraining period;
- PBMT before and after the aerobic training sessions and placebo during the detraining period;
- Placebo before and after the aerobic training sessions and PBMT during the detraining period;
- Placebo before and after the aerobic training sessions and placebo during the detraining period .
The individuals randomly allocated to the different groups will be subjected to 12 consecutive weeks of aerobic training performed on a treadmill 3 times a week on non-consecutive days. Each training session will last 30 minutes, with an intensity ranging from 85 to 90% maximum heart rate. PBMT or placebo will be applied before and after each training session. After the 12-week training period, the volunteers will receive the application of PBMT or placebo depending on the group to which they are allocated for 4 weeks (3 times a week) without training.
The data will be collected by a blind assessor. It will be analyzed time of the exercise (time until exhaustion), maximum oxygen consumption in absolute and relative values in relation to body mass (VO2max). Moreover, it will be evaluated the body composition. The evaluations will be performed before starting the protocol (baseline) and after 4, 8, and 12 weeks of training. They will also be performed after 4 weeks without training (detraining period).
The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and nonparametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. Data will be analyzed in terms of both their absolute values and their relationship to the percentage change based on the values established in the baseline tests. The significance level will be set at p<0.05.
- Conditions
- Aerobic Endurance
- Being tested
- PBMT, Placebo
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Aerobic Endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBMTDevice
PBMT will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for the applications during the training and/or detraining periods will be 30 Joules (J) per site (510 J per lower limb). PBMT will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.
PlaceboDevice
Placebo will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.
| Study group | Role | What they receive |
|---|---|---|
| PBMT + training/ PBMT + detraining | Experimental | PBMT applied before and after the aerobic training sessions (12 weeks, 3 times a week) and PBMT applied during the detraining period (4 weeks, 3 times a week). Receives: Device: PBMT |
| PBMT + training/ placebo + detraining | Experimental | PBMT applied before and after the aerobic training sessions (12 weeks, 3 times a week) and placebo applied during the detraining period (4 weeks, 3 times a week). Receives: Device: PBMT; Device: Placebo |
| Placebo + training/ PBMT + detraining | Experimental | Placebo applied before and after the aerobic training sessions (12 weeks, 3 times a week) and PBMT applied during the detraining period (4 weeks, 3 times a week). Receives: Device: PBMT; Device: Placebo |
| Placebo + training/ placebo + detraining | Placebo comparator | Placebo applied before and after the aerobic training sessions (12 weeks, 3 times a week) and placebo applied during the detraining period (4 weeks, 3 times a week). Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until exhaustion.
The time until exhaustion will be measured by the software of ergospirometry system.
Measured: 16 weeks - 4 weeks after completing the training (detraining period).
Secondary outcomes (3)
Time until exhaustion.
The time until exhaustion will be measured by the software of ergospirometry system.
Measured: 4, 8, and 12 weeks after starting the training period.
Maximum oxygen consumption (VO2).
The rates of maximum oxygen consumption will be measured by an ergospirometry test.
Measured: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Fat percentage.
Fat percentage will be measured by diameters, perimeters, and skinfolds.
Measured: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start25 Mar 2019
- Primary completion25 Aug 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aerobic EnduranceStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, 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
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Cesar Pinto Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879226
- Sponsor's protocol ID
- 1781602-2
- Status last verified
- Aug 2019
- First submitted
- 15 Mar 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request addressed to the principal investigator.
Publications
de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Ribeiro NF, Pereira AL, de Oliveira MFD, Alves MNDS, Dos Santos MC, Takara IET, Miranda EF, de Carvalho PTC, Leal-Junior ECP. Does the combination of photobiomodulation therapy (PBMT) and static magnetic fields (sMF) potentiate the effects of aerobic endurance training and decrease the loss of performance during detraining? A randomised, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Apr 10;12:23. doi: 10.1186/s13102-020-00171-2. eCollection 2020.
PubMed 32308987de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Miranda EF, Ribeiro NF, Pereira AL, da Costa AS, Dias LB, Souza BCG, Aguiar Lino MM, de Carvalho PTC, Leal-Junior ECP. Effects of photobiomodulation therapy in aerobic endurance training and detraining in humans: Protocol for a randomized placebo-controlled trial. Medicine (Baltimore). 2019 May;98(18):e15317. doi: 10.1097/MD.0000000000015317.
PubMed 31045769
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy in Aerobic Training and Detraining in Humans
- ClinicalTrials.gov ID
- NCT03879226
- Acronym / sponsor ID
- 1781602-2
- Conditions
- Aerobic Endurance
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Aerobic Endurance
- 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
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 18 Mar 2019 (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.
In last years it has been demonstrated that photobiomodulation therapy (PBMT) has ergogenic effects. However some key aspects, such as the potentially beneficial effects of PBMT during the detraining period still remain unknown.
Therefore, the aim of this project is to evaluate the effects of PBMT applied before and after aerobic training sessions and during the detraining period.
Detailed description
It will be carried out a randomized, triple-blind, placebo-controlled trial.
Seventy-two volunteers will be randomly allocated to four experimental groups:
- PBMT before and after the aerobic training sessions and PBMT during the detraining period;
- PBMT before and after the aerobic training sessions and placebo during the detraining period;
- Placebo before and after the aerobic training sessions and PBMT during the detraining period;
- Placebo before and after the aerobic training sessions and placebo during the detraining period .
The individuals randomly allocated to the different groups will be subjected to 12 consecutive weeks of aerobic training performed on a treadmill 3 times a week on non-consecutive days. Each training session will last 30 minutes, with an intensity ranging from 85 to 90% maximum heart rate. PBMT or placebo will be applied before and after each training session. After the 12-week training period, the volunteers will receive the application of PBMT or placebo depending on the group to which they are allocated for 4 weeks (3 times a week) without training.
The data will be collected by a blind assessor. It will be analyzed time of the exercise (time until exhaustion), maximum oxygen consumption in absolute and relative values in relation to body mass (VO2max). Moreover, it will be evaluated the body composition. The evaluations will be performed before starting the protocol (baseline) and after 4, 8, and 12 weeks of training. They will also be performed after 4 weeks without training (detraining period).
The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and nonparametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. Data will be analyzed in terms of both their absolute values and their relationship to the percentage change based on the values established in the baseline tests. The significance level will be set at p<0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBMT + training/ PBMT + detraining | Experimental | Device: PBMTPBMT applied before and after the aerobic training sessions (12 weeks, 3 times a week) and PBMT applied during the detraining period (4 weeks, 3 times a week). |
| PBMT + training/ placebo + detraining | Experimental | Device: PBMT, Device: PlaceboPBMT applied before and after the aerobic training sessions (12 weeks, 3 times a week) and placebo applied during the detraining period (4 weeks, 3 times a week). |
| Placebo + training/ PBMT + detraining | Experimental | Device: PBMT, Device: PlaceboPlacebo applied before and after the aerobic training sessions (12 weeks, 3 times a week) and PBMT applied during the detraining period (4 weeks, 3 times a week). |
| Placebo + training/ placebo + detraining | Placebo comparator | Device: PlaceboPlacebo applied before and after the aerobic training sessions (12 weeks, 3 times a week) and placebo applied during the detraining period (4 weeks, 3 times a week). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men;
- Aged from 18 to 35 years;
- Complete at least 80% of the study procedures will be included in the study.
Key exclusion criteria (4 listed)
- History of musculoskeletal injury in the hip and knee regions in the 2 months before the study;
- Become injured during the study;
- Regularly use pharmacological agents and/ or nutritional supplements;
- Signs and symptoms of any neurological, metabolic, inflammatory, pulmonary, oncological, or cardiovascular disease that may limit the execution of high-intensity exercises.
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 |
|---|---|---|
| PBMTPBMT will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for the applications during the training and/or detraining periods will be 30 Joules (J) per site (510 J per lower limb). PBMT will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated. | Device | PBMT + training/ PBMT + detraining, PBMT + training/ placebo + detraining, Placebo + training/ PBMT + detraining |
| PlaceboPlacebo will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated. | Device | PBMT + training/ placebo + detraining, Placebo + training/ PBMT + detraining, Placebo + training/ placebo + detraining |
Primary outcome
Time until exhaustion.
Time frame: 16 weeks - 4 weeks after completing the training (detraining period).
The time until exhaustion will be measured by the software of ergospirometry system.
3 secondary outcomes
Time until exhaustion.
Time frame: 4, 8, and 12 weeks after starting the training period.
Maximum oxygen consumption (VO2).
Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
Fat percentage.
Time frame: 4, 8, and 12 weeks after starting the training period, and at 4 weeks after completing the training (detraining period).
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 3 Sep 2019.
- Derived from this study: PubMed 32308987de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Ribeiro NF, Pereira AL, de Oliveira MFD, Alves MNDS, Dos Santos MC, Takara IET, Miranda EF, de Carvalho PTC, Leal-Junior ECP. Does the combination of photobiomodulation therapy (PBMT) and static magnetic fields (sMF) potentiate the effects of aerobic endurance training and decrease the loss of performance during detraining? A randomised, triple-blinded, placebo-controlled trial. BMC Sports Sci Med Rehabil. 2020 Apr 10;12:23. doi: 10.1186/s13102-020-00171-2. eCollection 2020.
- Derived from this study: PubMed 31045769de Paiva PRV, Casalechi HL, Tomazoni SS, Machado CDSM, Miranda EF, Ribeiro NF, Pereira AL, da Costa AS, Dias LB, Souza BCG, Aguiar Lino MM, de Carvalho PTC, Leal-Junior ECP. Effects of photobiomodulation therapy in aerobic endurance training and detraining in humans: Protocol for a randomized placebo-controlled trial. Medicine (Baltimore). 2019 May;98(18):e15317. doi: 10.1097/MD.0000000000015317.
- Individual participant dataSharing planned: Yes. Data will be shared upon request addressed to the principal investigator.
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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.
Ernesto Cesar Pinto Leal Junior, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBMT in people with Aerobic Endurance, 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 3 inclusion and 4 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 3 Sep 2019. 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?
Time until exhaustion. (time frame: 16 weeks - 4 weeks after completing the training (detraining period).). 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 NCT03879226, which also lists 2 linked publications.
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 3 Sep 2019.