- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02622971
Phototherapy and Cryotherapy in Post-exercise Skeletal Muscle Recovery
Isolated and Combined Effects of 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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01504-001
- Laboratory of Phototherapy in Sports and Exercise, Universidade Nove de Julho (UNINOVE)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PBMT and Cryotherapy
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.
|
Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
Other Names:
Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.
|
Active Comparator: Cryotherapy and PBMT
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.
|
Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
Other Names:
Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.
|
Active Comparator: PBMT (active phototherapy)
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.
|
Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
Other Names:
|
Placebo Comparator: PBMT (placebo phototherapy)
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.
|
Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
Other Names:
|
Active Comparator: Cryotherapy
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.
|
Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one week
|
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.
|
one week
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CEP 470.174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-exercise Muscle Recovery
-
Northumbria UniversityNewcastle University; Maastricht University; Sugar NutritionCompletedLiver and Muscle Glycogen Replenishment Post-exerciseUnited Kingdom
-
Maastricht University Medical CenterCompletedExercise RecoveryNetherlands
-
Tel Aviv UniversityRecruiting
-
Kemin Foods LCCompletedExercise Performance RecoveryUnited States
-
BioActorInnoSportNLCompletedExercise Recovery and EnduranceNetherlands
-
Anglia Ruskin UniversityCompletedOxidative Stress | Exercise RecoveryUnited Kingdom
-
University of ExeterBeachbodyCompletedMuscle RecoveryUnited Kingdom
-
BioActorCompletedMuscle Strength Recovery
-
Northumbria UniversityIprona Lana SpACompleted
Clinical Trials on PBMT
-
Universidade Cidade de Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of Nove de JulhoUniversity of BergenRecruiting
-
University of Nove de JulhoCompletedSkeletal Muscle PerformanceBrazil
-
University of Nove de JulhoCompleted
-
University of Nove de JulhoMulti Radiance MedicalCompleted
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São Paulo; Multi Radiance MedicalUnknown
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedMuscle; Fatigue, Heart | Skeletal Muscle RecoveryBrazil
-
Universidade Cidade de Sao PauloUniversity of Bergen; Fundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
University of Nove de JulhoMulti Radiance MedicalRecruitingLateral EpicondylitisBrazil
-
University of Nove de JulhoHospital Tacchini/RSCompletedCOVID-19 | Respiratory FailureBrazil