Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery

Post-exercise Muscle Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622971
• Other study ID #: CEP 470.174
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: February 2, 2016
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Fundação de Amparo a Pesquisa do Estado de São Paulo (FAPESP)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-exercise Muscle Recovery

Intervention

Other:
• PBMT
Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
• Cryotherapy
Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.

Locations

Country	Name	City	State
Brazil	Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Multi Radiance Medical

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination — View Citation

Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3. — View Citation

Bassett FH 3rd, Kirkpatrick JS, Engelhardt DL, Malone TR. Cryotherapy-induced nerve injury. Am J Sports Med. 1992 Sep-Oct;20(5):516-8. — View Citation

Graham CA, Stevenson J. Frozen chips: an unusual cause of severe frostbite injury. Br J Sports Med. 2000 Oct;34(5):382-3. — View Citation

Grandinétti Vdos S, Miranda EF, Johnson DS, de Paiva PR, Tomazoni SS, Vanin AA, Albuquerque-Pontes GM, Frigo L, Marcos RL, de Carvalho Pde T, Leal-Junior EC. The thermal impact of phototherapy with concurrent super-pulsed lasers and red and infrared LEDs — View Citation

Moeller JL, Monroe J, McKeag DB. Cryotherapy-induced common peroneal nerve palsy. Clin J Sport Med. 1997 Jul;7(3):212-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes