Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery

Study Overview
=================
Brief Summary
-----------------
Volunteers were divided randomly in five experimental groups. VAS (Visual Analogic scale) to measure DOMS (Delayed Onset Muscle Soreness) and blood samples was taken before any procedure. Then, volunteers performed stretching and warm-up followed by MVC test (isometric test in isokinetic dynamometer to measure muscle function). After, volunteers performed the exercise protocol (75 eccentric contractions) to lead to muscle fatigue. Immediately after exercise protocol (1 minute) and 1 hour, 24, 48, 72 and 96 hours after, blood sample, VAS measure and MVC test were repeated. The treatments according to randomisation were performed three minutes after exercise protocol and it were performed again in 24, 48, 72h after eccentric exercise. The variables regarding to muscle function (MVC, DOMS) and the indirect marker of muscle damage (CK activity) were monitored in all time points mentioned above (baseline, 1 minute, 1 hour, 24, 48, 72 and 96 hours after exercise protocol).

Detailed Description
-----------------
A randomized, double-blind, placebo-controlled clinical trial was performed at the Laboratory of Phototherapy in Sport and Exercise at Nove de Julho University in the city of São Paulo, Brazil. Fifty healthy untrained male subjects were recruited from university staff and students to participate in the study. All participants voluntarily must agree to participate and they signed the informed consent statement. The intention-to-treat analysis was followed. The volunteers were randomly allocated to five experimental groups (n=10 per group) according to the applied comparator. Randomisation was carried out by a simple drawing of lots (A, B, C, D or E). Blood samples (10 ml) was taken by a qualified nurse to analyse CK activity posteriorly. This blood collection was repeated 1 minute, 1 hour, 24, 48, 72 and 96 hours after eccentric protocol. A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher. DOMS assessments were performed at baseline, immediately after eccentric exercise protocol (1 minute), and it was repeated at 1, 24, 48, 72 and 96 hours after the exercise protocol. Before exercise protocol, volunteers will perform a stretching and warm-up of the non-dominant lower limb and then they will perform Maximum voluntary contraction (MVC) to evaluate muscle function. MVC measurements were repeated at the same time intervals as the CK measures. The exercise protocol consists in 75 eccentric isokinetic contractions of the knee extensor musculature in the non-dominant leg (5 sets of 15 repetitions, 30-second rest interval between sets) at a velocity of 60°.seg-1 in both the eccentric and concentric movements with a 60° range of motion (between 90° and 30° of knee flexion). Regarding to treatment, all volunteers received the treatment according to randomisation three minutes after eccentric exercise protocol. Comparators were repeated at 24, 48, and 72 hours following the collection of additional blood samples for CK analyses and MVC and DOMS assessments. The five groups was divided in: PBMT (photobiomodulation therapy)+cryotherapy; cryotherapy+PBMT; active PBMT; placebo PBMT and only cryotherapy. PBMT was applied employing a cordless, portable GameDay™ Super Pulsed Laser (manufactured by Multi Radiance Medical, USA) to 6 sites of quadriceps femoris in direct contact with the skin (2 centrally - rectus femoral and vastus intermedius; 2 laterally - vastus lateralis; and 2 medially - vastus medialis) and cryotherapy was done with two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) that will cover the entire quadriceps for 20 minutes.

Official Title
-----------------
Isolated and Combined Effects of Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery

Conditions
-----------------
Post-exercise Muscle Recovery

Intervention / Treatment
-----------------
* Other: PBMT
* Other: Cryotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects were included in the study if they performed less than 2 exercise session per week Exclusion Criteria: Subjects were excluded if occurred any musculoskeletal injury to hips or knees within the previous two months, if they were currently using pharmacological agents or nutritional supplements regularly, if a musculoskeletal injury during the study occurred or if they reported use of either alcohol or tobacco.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PBMT and Cryotherapy<br>Volunteers allocated in this group received phototherapy (PBMT - applied in six points of quadriceps) and cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. | Other: PBMT<br>* Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.<br>* Other names: photobiomodulation therapy;Other: Cryotherapy<br>* Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.<br>|
| Active Comparator: Cryotherapy and PBMT<br>Volunteers allocated in this group received cryotherapy (20 minutes in PRICE protocol) and phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. | Other: PBMT<br>* Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.<br>* Other names: photobiomodulation therapy;Other: Cryotherapy<br>* Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.<br>|
| Active Comparator: PBMT (active phototherapy)<br>Volunteers allocated in this group received active phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. | Other: PBMT<br>* Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.<br>* Other names: photobiomodulation therapy;|
| Placebo Comparator: PBMT (placebo phototherapy)<br>Volunteers allocated in this group received placebo phototherapy (PBMT - applied in six points of quadriceps) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. The placebo PBMT device was identical to the active devices and displayed the same settings and emitted the same sound regardless of the comparator. | Other: PBMT<br>* Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.<br>* Other names: photobiomodulation therapy;|
| Active Comparator: Cryotherapy<br>Volunteers allocated in this group cryotherapy (20 minutes in PRICE protocol) as a treatment three minutes and 24h, 48h and 72h after exercise protocol. Two flexible ice packs filled with ice cubes and water (with a volume of 1.15 liters each) were used in order to cover the entire quadriceps. Rubber belts were used to apply compression and to affix the packs tightly to the volunteers' quadriceps. | Other: Cryotherapy<br>* Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum voluntary contraction (MVC) | The MVC test consisted of three five-second isometric contractions of the knee extensors of the non-dominant leg. The highest torque value of the three contractions (peak torque) was used for statistical analysis. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Delayed Onset Muscle Soreness (DOMS) | A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher. | one week | 
| CK (Creatine Kinase) activity | Blood samples (10 ml) was taken by a qualified nurse blinded to the allocation of the volunteers to the five experimental groups from the antecubital vein. Spectrophotometry and specific reagent kits (Labtest®, São Paulo - SP, Brazil) were used to analyze CK (Creatine Kinase) activity as an indirect marker of muscle damage. | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phototherapy, cryotherapy, exercise, fatigue, recovery