- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985967
Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil, 01504-001
- Laboratory of Phototherapy and Innovative Technologies in Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Passive recovery for 30 minutes
|
Volunteers laid in supine position resting for 30 minutes.
|
|
Experimental: PBMT-sMF
Photobiomodulation therapy combined with static magnetic field, with a total treatment duration lasting for around 30 minutes.
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PBMT-sMF applied in the lower limbs with different doses per muscle group.
|
|
Active Comparator: Shock wave
Shock wave therapy applied for 30 minutes.
|
Shock wave therapy applied in the lower limbs for 30 minutes.
|
|
Active Comparator: Pneumatic compression
Pneumatic compression applied for 30 minutes.
|
Pneumatic compression applied in the lower limbs for 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1hour, 24 hours and 48 hours after WOD (workout of the day).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the activity of creatine kinase (CK)
Time Frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
|
The activity of CK will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
|
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).
|
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.
|
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.
|
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.
|
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).
|
The participants satisfaction regarding the interventions will be assessed through the LIKERT scale
|
48 hours after WOD (workout of the day).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ernesto Cesar Pinto Leal Junior, Ph.D., Full Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3.997.120-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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