Exercise RecoveryNCT06628609
Post-exercise Therapeutic Modalities on Functional Performance, Muscle Damage and Oxidative Stress of CrossFit® Athletes
A study testing Passive recovery, PBMT-sMF and Shock wave in people with Exercise Recovery, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Crossfit® is a training modality that consists in functional movements, constantly varied and executed at high intensity. Both training sessions and competitions involve physically demanding activities, which in addition to being performed at very high intensity also involves the aerobic metabolism pathway. 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
- Exercise Recovery
- What is being tested?
- Passive recovery, PBMT-sMF and Shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Oct 2024to 3 Nov 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
- Men only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: - Crossfit® amateur male athletes; - Do not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study; - Are not using pharmacological agents; - Athletes should have been practicing the sport for at least 1 year; - Voluntarily commit to participate in all stages of the study.
Exclusion Criteria: - Present musculoskeletal or joint injuries during data collection; - Present history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study.
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
Crossfit® is a training modality that consists in functional movements, constantly varied and executed at high intensity. Both training sessions and competitions involve physically demanding activities, which in addition to being performed at very high intensity also involves the aerobic metabolism pathway. These characteristics led to very high metabolic and muscular stress, as well as decrease in physical performance immediately after competitions and training sessions. The cumulative effects of the metabolic and muscular stress can be a precursor of injuries. Studies using different therapeutic modalities aiming to improve post-exercise recovery are needed in order to tackle this issue.
Oxidative stress induced by exercise has been a research field in constant growth, due to its relationship with the processes of fatigue, decreased production of muscle strength, and its ability to cause damage to the cell.
Read more
To the date there are no studies comparing the effects of different therapeutic modalities applied after an exercise session on functional performance, muscle damage, and oxidative stress in an exercise modality such as Crossfit®.
Therefore, the aim of this project is to assess and compare the effects of different therapeutic modalities on functional performance, muscle damage, and oxidative stress of Crossfit® athletes.
Read the detailed description
A randomized, crossover, controlled trial will be carried out.
All volunteers will be allocated to four interventions, and the order of the interventions will be randomized.
The outcomes will be assessed at baseline (prior to the Workout of the Day - WOD), and in different timepoints after the WOD.
The WOD will be consisted in finishing as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.
The investigators will analyze functional performance, biochemical markers of muscle damage and oxidative stress, the ratings of perceived exertion, and the volunteers satisfaction with the interventions.
All data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments.
- Conditions
- Exercise Recovery
- Being tested
- Passive recovery, PBMT-sMF, Shock wave, Pneumatic compression
- Keywords
- Therapeutic modalities, Exercise recovery, Muscle damage, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive recoveryOther
Volunteers laid in supine position resting for 30 minutes.
PBMT-sMFDevice
PBMT-sMF applied in the lower limbs with different doses per muscle group.
Shock waveDevice
Shock wave therapy applied in the lower limbs for 30 minutes.
Pneumatic compressionDevice
Pneumatic compression applied in the lower limbs for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Passive recovery for 30 minutes Receives: Other: Passive recovery |
| PBMT-sMF | Experimental | Photobiomodulation therapy combined with static magnetic field, with a total treatment duration lasting for around 30 minutes. Receives: Device: PBMT-sMF |
| Shock wave | Active comparator | Shock wave therapy applied for 30 minutes. Receives: Device: Shock wave |
| Pneumatic compression | Active comparator | Pneumatic compression applied for 30 minutes. Receives: Device: Pneumatic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional performance
The functional performance will be assessed through the countermovement jump (CMJ) test.
Measured: 1 hour after WOD (workout of the day).
Secondary outcomes (8)
Change in functional performance
The functional performance will be assessed through the countermovement jump (CMJ) test.
Measured: 24 hours and 48 hours after WOD (workout of the day)
Change in the activity of lactate dehydrogenase (LDH)
The activity of LDH will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in thiobarbituric acid (TBARS)
TBARS will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in carbonylated proteins
Carbonylated proteins will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in catalase (CAT) activity
CAT activity will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in superoxide dismutase (SOD) activity
SOD activity will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
Measured: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Participants' perceived exercise intensity
The perception of exercise intensity will be assessed through a 0-100 Ratings of Perceived Exertion Scale: in this scale lower score, means lower degree of fatigue and higher score, means higher degree of fatigue.
Measured: 1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.
Participants' satisfaction regarding the interventions
The participants satisfaction regarding the interventions will be assessed through the LIKERT scale.
Measured: 48 hours after WOD (workout of the day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start11 Oct 2024
- Primary completion3 Nov 2024
- Study completion3 Nov 2024
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 Exercise RecoveryStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Cesar Pinto Leal Junior, Ph.D., M.Sc., PT., Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628609
- Sponsor's protocol ID
- 3.997.120
- Status last verified
- Nov 2024
- First submitted
- 3 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared upon request addressed to the principal investigator.
Publications
Martins PHGN, Tomazoni SS, Machado CDSM, Pereira AL, Pinto HD, Lino MMA, Ribeiro NF, Dias LB, Aleixo Junior IO, de Oliveira MFD, de Araujo-Silva OM, De Marchi T, Casalechi HL, Leal-Junior ECP. A randomised crossover trial comparing photobiomodulation therapy with other recovery strategies in CrossFit athletes. PLoS One. 2026 May 22;21(5):e0349880. doi: 10.1371/journal.pone.0349880. eCollection 2026.
PubMed 42172262
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-exercise Therapeutic Modalities on Functional Performance, Muscle Damage and Oxidative Stress of CrossFit® Athletes
- ClinicalTrials.gov ID
- NCT06628609
- Acronym / sponsor ID
- 3.997.120
- Conditions
- Exercise Recovery
- Keywords
- Therapeutic modalities, Exercise recovery, Muscle damage, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 3 Nov 2024 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 8 Oct 2024 (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.
Crossfit® is a training modality that consists in functional movements, constantly varied and executed at high intensity. Both training sessions and competitions involve physically demanding activities, which in addition to being performed at very high intensity also involves the aerobic metabolism pathway. These characteristics led to very high metabolic and muscular stress, as well as decrease in physical performance immediately after competitions and training sessions. The cumulative effects of the metabolic and muscular stress can be a precursor of injuries. Studies using different therapeutic modalities aiming to improve post-exercise recovery are needed in order to tackle this issue.
Oxidative stress induced by exercise has been a research field in constant growth, due to its relationship with the processes of fatigue, decreased production of muscle strength, and its ability to cause damage to the cell.
To the date there are no studies comparing the effects of different therapeutic modalities applied after an exercise session on functional performance, muscle damage, and oxidative stress in an exercise modality such as Crossfit®.
Therefore, the aim of this project is to assess and compare the effects of different therapeutic modalities on functional performance, muscle damage, and oxidative stress of Crossfit® athletes.
Detailed description
A randomized, crossover, controlled trial will be carried out.
All volunteers will be allocated to four interventions, and the order of the interventions will be randomized.
The outcomes will be assessed at baseline (prior to the Workout of the Day - WOD), and in different timepoints after the WOD.
The WOD will be consisted in finishing as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.
The investigators will analyze functional performance, biochemical markers of muscle damage and oxidative stress, the ratings of perceived exertion, and the volunteers satisfaction with the interventions.
All data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Passive recoveryPassive recovery for 30 minutes |
| PBMT-sMF | Experimental | Device: PBMT-sMFPhotobiomodulation therapy combined with static magnetic field, with a total treatment duration lasting for around 30 minutes. |
| Shock wave | Active comparator | Device: Shock waveShock wave therapy applied for 30 minutes. |
| Pneumatic compression | Active comparator | Device: Pneumatic compressionPneumatic compression applied for 30 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Passive recoveryVolunteers laid in supine position resting for 30 minutes. | Other | Control |
| PBMT-sMFPBMT-sMF applied in the lower limbs with different doses per muscle group. | Device | PBMT-sMF |
| Shock waveShock wave therapy applied in the lower limbs for 30 minutes. | Device | Shock wave |
| Pneumatic compressionPneumatic compression applied in the lower limbs for 30 minutes. | Device | Pneumatic compression |
Primary outcome
Change in functional performance
Time frame: 1 hour after WOD (workout of the day).
The functional performance will be assessed through the countermovement jump (CMJ) test.
8 secondary outcomes
Change in functional performance
Time frame: 24 hours and 48 hours after WOD (workout of the day)
Change in the activity of lactate dehydrogenase (LDH)
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in thiobarbituric acid (TBARS)
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in carbonylated proteins
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in catalase (CAT) activity
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in superoxide dismutase (SOD) activity
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Participants' perceived exercise intensity
Time frame: 1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.
Participants' satisfaction regarding the interventions
Time frame: 48 hours after WOD (workout of the day).
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 6 Nov 2024.
- Derived from this study: PubMed 42172262Martins PHGN, Tomazoni SS, Machado CDSM, Pereira AL, Pinto HD, Lino MMA, Ribeiro NF, Dias LB, Aleixo Junior IO, de Oliveira MFD, de Araujo-Silva OM, De Marchi T, Casalechi HL, Leal-Junior ECP. A randomised crossover trial comparing photobiomodulation therapy with other recovery strategies in CrossFit athletes. PLoS One. 2026 May 22;21(5):e0349880. doi: 10.1371/journal.pone.0349880. eCollection 2026.
- 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, Ph.D., M.Sc., PT. principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive recovery, PBMT-sMF and Shock wave in people with Exercise Recovery, 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?
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 6 Nov 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. 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?
Change in functional performance (time frame: 1 hour after WOD (workout of the day).). 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 NCT06628609, 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 6 Nov 2024.