Muscle StrengthNCT05985967
Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes
A study testing PBMT-sMF, Shock wave and Pneumatic compression in people with Muscle Strength, 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
- Muscle Strength
- What is being tested?
- PBMT-sMF, Shock wave and Pneumatic compression
- 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
- 9 Aug 2023to 10 Sep 2023
- 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
- 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.
Who cannot join
- Present musculoskeletal or joint injuries during data collection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
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.
However, to the date there are no studies investigating the effects of different therapeutic modalities in an exercise modality such as Crossfit®. Therefore, the aim of this project is to assess the effects of different therapeutic modalities on performance and muscle recovery of Crossfit® athletes.
Read the detailed description
It will be carried out a randomized, crossover, controlled trial.
Volunteers will be allocated to four interventions, and the order of the interventions will be randomized.
The outcomes will be obtained at baseline (prior to the Workout of the Day - WOD), and in different timepoints after that.
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: the maximum number of free squats performed in 1 minute; the activity of creatine kinase (CK); the levels of Interleukin-6 (IL-6); 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
- Muscle Strength
- Being tested
- PBMT-sMF, Shock wave, Pneumatic compression, Passive recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Passive recoveryOther
Volunteers laid in supine position resting 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 capacity
The functional capacity will be assessed through the maximum number of free squat repetitions performed within 1 minute.
Measured: 1hour, 24 hours and 48 hours after WOD (workout of the day).
Secondary outcomes (4)
Change in the activity of creatine kinase (CK)
The activity of CK 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 the levels of interleukin-6 (IL-6)
The levels of interleukin-6 will be analyzed from the blood samples collected from the participants through enzyme-linked immunosorbent assay (ELISA) 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 posted14 Aug 2023
- Study start9 Aug 2023
- Primary completion10 Sep 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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., Principal investigator, Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985967
- Sponsor's protocol ID
- 3.997.120-1
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2023
- Last updated
- 4 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes
- ClinicalTrials.gov ID
- NCT05985967
- Acronym / sponsor ID
- 3.997.120-1
- Conditions
- Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 14 Aug 2023 (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.
However, to the date there are no studies investigating the effects of different therapeutic modalities in an exercise modality such as Crossfit®. Therefore, the aim of this project is to assess the effects of different therapeutic modalities on performance and muscle recovery of Crossfit® athletes.
Detailed description
It will be carried out a randomized, crossover, controlled trial.
Volunteers will be allocated to four interventions, and the order of the interventions will be randomized.
The outcomes will be obtained at baseline (prior to the Workout of the Day - WOD), and in different timepoints after that.
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: the maximum number of free squats performed in 1 minute; the activity of creatine kinase (CK); the levels of Interleukin-6 (IL-6); 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Present musculoskeletal or joint injuries during data collection.
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 |
|---|---|---|
| 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 |
| Passive recoveryVolunteers laid in supine position resting for 30 minutes. | Other | Control |
Primary outcome
Change in functional capacity
Time frame: 1hour, 24 hours and 48 hours after WOD (workout of the day).
The functional capacity will be assessed through the maximum number of free squat repetitions performed within 1 minute.
4 secondary outcomes
Change in the activity of creatine kinase (CK)
Time frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Change in the levels of interleukin-6 (IL-6)
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 4 Sep 2024.
- Individual participant dataSharing planned: Yes. Data will be shared upon request addressed to the principal investigator.
Related trials for Muscle Strength
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Not yet recruiting
Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
Aging, Muscle Strength
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. principal investigator
Full Professor
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-sMF, Shock wave and Pneumatic compression in people with Muscle Strength, 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 4 Sep 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 capacity (time frame: 1hour, 24 hours and 48 hours 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?
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 4 Sep 2024.