Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery

Study Overview
=================
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%.

Detailed Description
-----------------
This is a randomized, double-blind, crossover, controlled clinical trial of sham therapy.

Official Title
-----------------
Comparison Between Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Muscle Recovery in Crossfit Athletes

Conditions
-----------------
Laser, Muscle; Fatigue, Heart, Muscle Damage

Intervention / Treatment
-----------------
* Other: Photobiomodulation; Cryotherapy, Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation<br>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<br>* 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.<br>|
| Sham Comparator: Sham Photobiomodulation<br>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<br>* 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.<br>|
| Experimental: Active Cryotherapy<br>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<br>* 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.<br>|
| Sham Comparator: Sham Cryotherapy<br>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<br>* 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.<br>|
| Experimental: Massage<br>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<br>* 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.<br>|
| Sham Comparator: Sham Massage<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photobiomodulation, Crossfit, Muscle Damage