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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985967
Other study ID # 3.997.120-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 9, 2023
Est. completion date September 2023

Study information

Verified date August 2023
Source University of Nove de Julho
Contact Heliodora Casalechi, Ph.D.
Phone +55 11 3385 9134
Email lapit@eljconsultancy.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
PBMT-sMF
PBMT-sMF applied in the lower limbs with different doses per muscle group.
Shock wave
Shock wave therapy applied in the lower limbs for 30 minutes.
Pneumatic compression
Pneumatic compression applied in the lower limbs for 30 minutes.
Other:
Passive recovery
Volunteers laid in supine position resting for 30 minutes.

Locations

Country Name City State
Brazil Laboratory of Phototherapy and Innovative Technologies in Health São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in functional capacity 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 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. 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Secondary 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. 1 hour, 24 hours and 48 hours after WOD (workout of the day).
Secondary 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. 1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.
Secondary Participants' satisfaction regarding the interventions The participants satisfaction regarding the interventions will be assessed through the LIKERT scale 48 hours after WOD (workout of the day).
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