NCT05627141

Brief Summary

Skeletal muscle fatigue is an inevitable phenomenon in the training and competition routine for many crossfit athletes, which can impair their physical performance and predispose them to musculoskeletal injuries. Thus, strategies and/or therapies that minimize fatigue and accelerate muscle recovery are extremely relevant for everyone involved with sport. The aim of the present study is to investigate and compare the effects of photobiomodulation, cryotherapy combined with compression, and massage as isolated therapies for muscle recovery after a protocol of induced muscle damage and fatigue in Crossfit athletes. This is a randomized, double-blind, crossover, sham-controlled clinical trial. Will be recruited 60 male participants, adults, aged between 18 and 40 years, Crossfit practitioners. They will be randomly allocated into 3 groups of 20 participants per therapy, each crossed between effective and sham every 15 days. The primary outcome will be muscle performance in functional test (free squat) and knee extensor torque in maximal voluntary isometric contraction (MVIC). Secondary outcomes will be evaluated by the levels of muscle damage via creatine phosphokinase (CPK) and inflammatory process via blood C-reactive protein (CRP); and delayed onset muscle pain via numerical verbal scale (0-10). All outcomes will be evaluated at baseline, 24h and 48h after induction of muscle damage and fatigue. Data will be analyzed and compared intra and inter groups with a significance level of 5%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 2, 2022

Last Update Submit

April 12, 2026

Conditions

Keywords

PhotobiomodulationCrossfitMuscle Damage

Outcome Measures

Primary Outcomes (3)

  • Muscle Force Dynamometry

    participants will be evaluated regarding the dominant knee extensor torque during maximal voluntary isometric contraction (MVIC) in an extensor chair.

    48 hours

  • Blood markers of muscle damage and inflammatory process

    To measure the serum levels of CPK and CRP, blood samples will be collected after aseptic cleaning of the ventral side of the dominant arm. All blood collection procedures will be performed by a qualified nurse (who will not know to which group each participant will belong). Collections will be performed using vacuum collection tubes, without anticoagulant (10ml), centrifuged at 4,000g for 5 minutes, and stored at -80°C until analysis. Blood collections will be performed at baseline (before WOD and leg extension exercise), 24h and 48h after. Blood analysis will be performed using infrared spectrophotometry in a clinical analysis laboratory (Matter Diagnósticos, Campo Grande, MS) and by an evaluator who is blinded to the therapies applied.

    48 hours

  • Delayed onset muscle pain

    The subjective perception of pain will be through a numerical verbal scale (NVS) graduated in centimeters (from 0 to 10), where 0 corresponds to no pain, and 10 corresponds to the maximum possible pain (HAWKER et al., 2011). Pain will be provoked in participants through CIVM for knee extension of the dominant lower limb, in full extension (0°) and without load (FERRARESI et al., 2016). Volunteers will be asked about the level of pain they will feel immediately before WOD and MVIC in a leg extension, 24h and 48h after.

    48 hours

Study Arms (6)

Photobiomodulation

EXPERIMENTAL

10 participants will receive active photobiomodulation immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session

Other: Photobiomodulation; Cryotherapy, Massage

Sham Photobiomodulation

SHAM COMPARATOR

10 participants will receive sham photobiomodulation immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session

Other: Photobiomodulation; Cryotherapy, Massage

Active Cryotherapy

EXPERIMENTAL

10 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression on the lower limbs, or sham (25°C for 20 min) damage and fatigue induction protocol. muscle.

Other: Photobiomodulation; Cryotherapy, Massage

Sham Cryotherapy

SHAM COMPARATOR

10 participants will receive sham cryotherapy (25°C for 20 min) combined with light compression on the lower limbs immediately after the damage and fatigue induction protocol. muscle.

Other: Photobiomodulation; Cryotherapy, Massage

Massage

EXPERIMENTAL

10 participants will receive the effective massage immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session.

Other: Photobiomodulation; Cryotherapy, Massage

Sham Massage

SHAM COMPARATOR

10 participants will receive the sham massage immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session.

Other: Photobiomodulation; Cryotherapy, Massage

Interventions

Photobiomodulation: the 20 participants will receive active photobiomodulation or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Cryotherapy combined with compression: the 20 participants will receive effective cryotherapy (10-12°C for 20 min) combined with high compression, or sham (25°C for 20 min) combined with light compression, on the lower limbs, immediately after the protocol. induction of muscle damage and fatigue. Effective cryotherapy or sham will be applied in a randomized and crossover manner, with an interval of 15 days between each evaluation session. Massage: the 20 participants will receive the effective massage or sham immediately after the muscle damage and fatigue induction protocol in a randomized and crossover manner, with an interval of 15 days between each evaluation session.

Active CryotherapyMassagePhotobiomodulationSham CryotherapySham MassageSham Photobiomodulation

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male participants;
  • Adults; aged between 18 and 40 years;
  • Body mass index (BMI) between 18 and 30 kg/m2;
  • Crossfit practitioners of the scale, amateur, RX and elite categories;
  • Training at least 5 days a week.

You may not qualify if:

  • Orthopedic injuries in the lower limbs (2 months) or during the development of the study will be excluded;
  • Participants with less than 5 training sessions per week;
  • Participants making regular use of pharmacological agents and/or ergogenic supplements;
  • Participants who regularly use alcohol and/or tobacco;
  • Participants with skin lesions (open wounds) on the lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filipe Abdalla

Campo Grande, Mato Grosso do Sul, 79117504, Brazil

Location

MeSH Terms

Conditions

Fatigue

Interventions

Low-Level Light TherapyCryotherapyMassage

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Filipe A dos Reis, PhD

    Ufscar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universidade Anhanguera

Study Record Dates

First Submitted

March 2, 2022

First Posted

November 25, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations