- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03287284
Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity
31. juli 2018 opdateret af: Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre
Phototherapy has been largely used in rehabilitation programs due to its analgesic, antiinflammatory and healing effects.
Lately, its effects of optimizing the results of resistance training on young individuals have been studied.
However, there is a lack of studies on its effect on the elderly population.
The objective of the present study is to verify the effect of Low-Level Laser Therapy (LLLT) on the results of resistance training in the elderly.
The study will be a randomized doubled-blinded controlled trial.
30 elderly men with age ranging from 60 to 80 years will be included and randomized between Placebo Group (placebo LLLT + Resistance Training) and LLLT Group (active LLLT + Resistance Training).
All volunteers will be submitted to a control period of four weeks before the beginning of the resistance training, which will have 12 weeks of duration.
The assessments will be done at baseline, after the control period and after the training period.
The training sessions will be performed twice a week and the training protocol will be performed with repetition maximum periodization.
The LLLT will be applied before the training sessions on eight points of the quadriceps muscles, leading to a total of 240 Joules on each leg.
The placebo LLLT will be applied on the same way, but with the equipment turned off.
The assessments will include muscle architecture by ultrasonography, muscle strength by isokinetic dynamometer and 1 Repetition Maximum test of leg-extension and leg-press exercises, and functional capacity by the 6-Minute Walking Test, 30s Sit to Stand Test, Timed Up-and-Go Test and Stair Ascent Test.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Pôrto Alegre, Brasilien
- Universidade Federal do Rio Grande do Sul
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Elderly men with age ranging from 60 to 80 years in condition to participate in the strength training program.
Exclusion Criteria:
- Individuals who already participate in strength training programs;
- Individuals who participated in strength training programs less than three months before the beginning of the study;
- Individuals with any kind musculoskeletal injuries in the lower limbs that impair the performance of the exercises;
- Individuals with contraindications to the performance of high intensity exercises, such as cardiovascular or neurological diseases;
- Individuals with difficulties in understanding and/or performing the exercises;
- Individuals who did not attend to at least 85% of the sessions or had 02 consecutive absences and did not recover them.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: LLLT Group
Active Low Level Laser Therapy application with a dose of 240 Joules before resistance training
|
Active application of Low Level Laser Therapy with a dose of 240 Joules
Resistance Training
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Placebo komparator: Placebo Group
Placebo Low Level Laser Therapy application before resistance training
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Resistance Training
Placebo application of Low Level Laser Therapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Isokinetic peak torque of quadriceps muscle
Tidsramme: Change from baseline in isokinetic peak torque at 12 weeks
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Change from baseline in isokinetic peak torque at 12 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Leg-extension 1RM test
Tidsramme: Change from baseline in leg-extension 1RM test at 12 weeks
|
Change from baseline in leg-extension 1RM test at 12 weeks
|
|
Leg-press 1RM test
Tidsramme: Change from baseline in leg-press 1RM test at 12 weeks
|
Change from baseline in leg-press 1RM test at 12 weeks
|
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Muscle architecture
Tidsramme: Change from baseline in muscle architecture at 12 weeks
|
Change from baseline in muscle architecture at 12 weeks
|
|
Physical Function
Tidsramme: Change from baseline in physical function at 12 weeks
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Change from baseline in physical function at 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. marts 2017
Primær færdiggørelse (Faktiske)
22. december 2017
Studieafslutning (Faktiske)
22. december 2017
Datoer for studieregistrering
Først indsendt
15. september 2017
Først indsendt, der opfyldte QC-kriterier
15. september 2017
Først opslået (Faktiske)
19. september 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 59328316.9.0000.5345
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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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