NCT02622971

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

November 24, 2015

Last Update Submit

February 2, 2016

Conditions

Keywords

phototherapycryotherapyexercisefatiguerecovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Evaluation of Delayed Onset Muscle Soreness (DOMS)

    one week

  • CK (Creatine Kinase) activity

    one week

Study Arms (5)

PBMT and Cryotherapy

ACTIVE COMPARATOR

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: PBMTOther: Cryotherapy

Cryotherapy and PBMT

ACTIVE COMPARATOR

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: PBMTOther: Cryotherapy

PBMT (active phototherapy)

ACTIVE COMPARATOR

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

PBMT (placebo phototherapy)

PLACEBO COMPARATOR

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

Cryotherapy

ACTIVE COMPARATOR

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

Interventions

PBMTOTHER

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

Also known as: photobiomodulation therapy
Cryotherapy and PBMTPBMT (active phototherapy)PBMT (placebo phototherapy)PBMT and Cryotherapy

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

CryotherapyCryotherapy and PBMTPBMT and Cryotherapy

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects were included in the study if they performed less than 2 exercise session per week

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 01504-001, Brazil

Location

Related 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 of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.

  • Grandinetti 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 on human skin. Lasers Med Sci. 2015 Jul;30(5):1575-81. doi: 10.1007/s10103-015-1755-0. Epub 2015 May 19.

  • 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.

  • Graham CA, Stevenson J. Frozen chips: an unusual cause of severe frostbite injury. Br J Sports Med. 2000 Oct;34(5):382-3. doi: 10.1136/bjsm.34.5.382.

  • Moeller JL, Monroe J, McKeag DB. Cryotherapy-induced common peroneal nerve palsy. Clin J Sport Med. 1997 Jul;7(3):212-6. doi: 10.1097/00042752-199707000-00011.

  • Bassett FH 3rd, Kirkpatrick JS, Engelhardt DL, Malone TR. Cryotherapy-induced nerve injury. Am J Sports Med. 1992 Sep-Oct;20(5):516-8. doi: 10.1177/036354659202000505.

MeSH Terms

Conditions

Motor ActivityFatigue

Interventions

Low-Level Light TherapyCryotherapy

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Ernesto Cesar P Leal-Junior, PhD, PT

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 7, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

all data is stored and saved in electronic devices to clarify any possible doubt regarding to methodological procedures and results.

Locations