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Completed

NCT Number: NCT02622971

Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery

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).

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)

São Paulo, 01504-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PBMT

Other

Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.

Other names: photobiomodulation therapy

Cryotherapy

Other

Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.

Primary outcomes

  1. Maximum voluntary contraction (MVC)

    Time frame: one week

    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.

Secondary outcomes

  1. Evaluation of Delayed Onset Muscle Soreness (DOMS)

    Time frame: one week

    A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher.

  2. CK (Creatine Kinase) activity

    Time frame: one week

    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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Multi Radiance Medical

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 7, 2015
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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