- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02715050
Phototherapy Applied in Association With Muscular Training
Phototherapy Applied in Association With Muscular Training: Evaluation of Different Moments of Applications
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a clinical, randomized, controlled placebo and double-blind study. Forty-eight participants performed muscular training protocol. Subjects practiced a protocol training with 60% of the load followed by 80% of the load, measured through 1-repetition maximum test, in all sessions of the training protocol. The training protocol consisted in performing 3 sets of 7 repetitions with 60% of 1-RM, and 4 set of 7 repetitions with 80% of 1-RM. This protocol was performed in every sessions, three times a week, employing leg press and leg extension machines.
Phototherapy, active or placebo, were applied in 6 different points of anterior muscle of the thigh before and after each training session. Only one investigator, that did not participate in any phase of the assessments and trainings sessions, knew about what program is active or placebo in phototherapy device. Randomisation carried out by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. Either strength training lasted 12 weeks and assessments were performed at baseline, 4, 8 and 12 weeks. There were evaluated maximal voluntary contraction (MVC), concentric torque, bilateral thigh perimetry and 1-repetition maximum test (1-RM).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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SP
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São Paulo, SP, Brasilien, 01504-001
- Universidade Nove de Julho
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- healthy individuals,
- active, that performed less than two exercise sessions per week
- when they presented musculoskeletal injury to the hips or knees in the previous 2 months,
- used pharmacological agents or nutritional supplements regularly, and
- Subjects that did not attend a minimum rate of 80% of all strength training sessions
- Suffered musculoskeletal injury during the ongoing of the study were also excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group A - Active or Placebo Phototherapy
Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group A, received program 1 before strength training, and the same program 1 after training. |
Andre navne:
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Eksperimentel: Group B - Active or Placebo Phototherapy
Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group B, received program 1 before strength training, and program 2 after training. |
Andre navne:
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Eksperimentel: Group C - Active or Placebo Phototherapy
Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group C, received program 2 before strength training, and program 1 after training. |
Andre navne:
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Eksperimentel: Group D - Active or Placebo Phototherapy
Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group D, received program 2 before strength training, and program 2 after training. |
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline Maximum voluntary contraction in the isokinetic dynamometer (MVC) at 12 weeks
Tidsramme: 12 weeks
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Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training
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12 weeks
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Change from baseline Concentric Torque at 12 weeks
Tidsramme: 12 weeks
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Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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1-RM test
Tidsramme: 12 weeks
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Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training.
This test estimated the load of the exercises.
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12 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Thigh perimetry
Tidsramme: 12 weeks
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Muscle mass measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training.
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12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Ernesto Leal-Junior, PhD, University of Nove de Julho
Publikationer og nyttige links
Generelle publikationer
- 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.
- Leal-Junior EC, Vanin AA, Miranda EF, de Carvalho Pde T, Dal Corso S, Bjordal JM. Effect of phototherapy (low-level laser therapy and light-emitting diode therapy) on exercise performance and markers of exercise recovery: a systematic review with meta-analysis. Lasers Med Sci. 2015 Feb;30(2):925-39. doi: 10.1007/s10103-013-1465-4. Epub 2013 Nov 19.
- Seynnes OR, de Boer M, Narici MV. Early skeletal muscle hypertrophy and architectural changes in response to high-intensity resistance training. J Appl Physiol (1985). 2007 Jan;102(1):368-73. doi: 10.1152/japplphysiol.00789.2006. Epub 2006 Oct 19.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PhD437.894
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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