- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06628609
Post-exercise Therapeutic Modalities on Functional Performance, Muscle Damage and Oxidative Stress 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
SP
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São Paulo, SP, 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; - Present history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study.
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.
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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.
|
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Active Comparator: Shock wave
Shock wave therapy applied for 30 minutes.
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Shock wave therapy applied in the lower limbs for 30 minutes.
|
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Active Comparator: Pneumatic compression
Pneumatic compression applied for 30 minutes.
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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 performance
Time Frame: 1 hour after WOD (workout of the day).
|
The functional performance will be assessed through the countermovement jump (CMJ) test.
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1 hour after WOD (workout of the day).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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.
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1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.
|
|
Change in functional performance
Time Frame: 24 hours and 48 hours after WOD (workout of the day)
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The functional performance will be assessed through the countermovement jump (CMJ) test.
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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).
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The activity of LDH will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
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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).
|
TBARS will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
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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).
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Carbonylated proteins will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
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1 hour, 24 hours and 48 hours after WOD (workout of the day).
|
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Change in catalase (CAT) activity
Time Frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
|
CAT activity 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).
|
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Change in superoxide dismutase (SOD) activity
Time Frame: 1 hour, 24 hours and 48 hours after WOD (workout of the day).
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SOD activity will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.
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1 hour, 24 hours and 48 hours after WOD (workout of the day).
|
|
Participants' satisfaction regarding the interventions
Time Frame: 48 hours after WOD (workout of the day).
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The participants satisfaction regarding the interventions will be assessed through the LIKERT scale.
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48 hours after WOD (workout of the day).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ernesto Cesar Pinto Leal Junior, Ph.D., M.Sc., PT., Nove de Julho University
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
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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