- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03112239
Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients
Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Moderate to Severe Asthmatic Patients: a Randomized Controlled Clinical Trial.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This research project will be prospective, analytical and of the randomized controlled clinical trial type, with blind evaluator. The sample type will be consecutive from Santa Casa de Misericórdia de São Paulo. We will study 30 adults of both sexes with moderate to severe asthma between the ages of 20 and 70, based on the sample calculation of the outcomes of this study.
Adult individuals 20 years of age or older with a diagnosis of moderate to severe asthma of both sexes, attended at the Ambulatory of Difficult Asthma Control of Santa Casa de Misericórdia de São Paulo.
Exclusion terms include subjects diagnosed as having heart disease associated with pulmonary disease, musculoskeletal pathology that may interfere with assessment or exercise, pulmonary hypertension, calcium absorption deficiency, BMI ≥ 30 or difficulty learning.
The subjects will initially be pre-evaluated by performing pulmonary function tests, peripheral muscle strength (1-RM), functional capacity tests, physical activity questionnaires and clinical control of asthma and cardiopulmonary exercise test. After the evaluation, patients will be randomized into two resistance training groups, one of them associated with active LED phototherapy and another LED phototherapy placebo.
The resistance exercise protocol will be performed on the muscles: Pectoral, Large Dorsal, Brachial Biceps, Brachial Triceps, Quadriceps and Tibial Ischia. The intensity will be from 40 to 70% obtained in the 1-RM test with two to three sets of ten repetitions.
The load increase will be performed weekly (5%) according to patient tolerance. After 12 weeks all subjects were reevaluated and the last reevaluation occurred at the end of the training program. Patients will only effectively begin participating in this study after explaining the terms of the survey and by accepting written consent from the ICF.
The mean (in kg) of the resistance training protocol for lower limbs in knee extension of group 1 was 33 ± 13 kg and the mean of group 2 was 46 ± 11 kg. The sample calculation was based on the load of the quadriceps muscle, α = 0.05 and β = 95%, determining a minimum of fourteen individuals for each group. An additional 10% was added to compensate for possible losses during the protocol. Thus a minimum of fifteen individuals will be required for the study.
Linear regression models will be used to evaluate the effect of the LED on the results (absolute change and percentage) and a sensitivity analysis with the values of the results in the revaluation, adjusted by the initial value of each result. The possible correlations between the variables can be evaluated using Pearson's correlation. The level of significance adopted will be p <0.5. The analyzes were performed with SPSS 20 software.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
São Paulo, Brasil, 05415-012
- Ivan Peres Costa
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients with a medical outpatient setting less than six months; With a stable clinical picture during three months, ie without exacerbations and with optimized drug therapy.
Signed an informed consent form (TCLE) accepting participation in the research.
Exclusion Criteria:
- Diagnosis of heart disease associated with lung disease, musculoskeletal disease that may interfere with assessment or exercise, pulmonary hypertension, calcium absorption deficiency, BMI ≥ 30, or difficulty learning.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: photobiomodulation by active LEDT
The subjects will be initially pre-evaluated by performing pulmonary function tests, peripheral muscle strength tests, functional capacity tests, physical activity questionnaires and clinical control of asthma, and cardiopulmonary exercise test.
After the evaluation, patients will be randomized into two resistance training groups, one of them being associated to the intervention with active photobiomodulation by LEDT to increase peripheral muscle function post resistance training.
|
Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.
Andre navn:
|
Placebo komparator: photobiomodulation by Placebo LEDT
The subjects will be initially pre-evaluated by performing pulmonary function tests, peripheral muscle strength tests, functional capacity tests, physical activity questionnaires and clinical control of asthma, and cardiopulmonary exercise test.
After the evaluation, patients will be randomized into two resistance training groups, one of them being associated to the intervention with placebo LEDT photobiomodulation to increase peripheral muscle function post resistance training.
|
Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Pectoral Muscular Strength by 1RM.
Tidsramme: Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Muscle strength will be assessed in the pectoral muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
|
Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Major Dorsal Muscular Strength by 1RM
Tidsramme: Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Muscle strength will be assessed in the major dorsal muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
|
Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Femoral Quadriceps Muscular Strength by 1RM
Tidsramme: Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Muscle strength will be assessed in the femoral quadriceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
|
Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Brachial Triceps Muscular Strength by 1RM
Tidsramme: Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Muscle strength will be assessed in the brachial triceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
|
Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Brachial Biceps Muscular Strength by 1RM
Tidsramme: Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Muscle strength will be assessed in the brachial biceps muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
|
Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Tibial Ischia Muscular Strength by 1RM
Tidsramme: Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Muscle strength will be assessed in the tibial ischia muscle group, using the maximal repetition (1RM) test to quantify the resistance training load (between 60 and 80%).
|
Change from Baseline Peripheral muscular Strength up to 24 weeks.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Functional Capacity by Cardiopulmonary exercise test.
Tidsramme: Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
|
The cardiopulmonary test will be performed in an electricomagnetic braking cycle ergometer connected to a system composed of gas analysis module attached to a module flow/wave analyzer and a microcomputer BreezeCardiO2 System.
(medical Graphics Corporation - MGC, St. Paul, Mo, USA).
|
Change from baseline measured by cardiopulmonary exercise test up to 24 weeks.
|
Functional Capacity by Incremental Shuytle Walk Test.
Tidsramme: Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.
|
The incremental shuttle walk test was performed based on the original test description.
The patient walk from side to side in a space of 10 meters identified by two cones inserted 0.5 from each end to avoid such sudden changes in speed.
The participant was instructed to walk from cone to cone in one.
A single point that the participant must keep pace and a triple beep indicates the beginning of a new level, the height at which the participant has increased the pace.
The test comprised 12 levels, each lasting one minute.
The speed of the first level was 1.8 Km/h, with an increase of 0.17 m/s every minute until reaching a top speed of 8.53 Km/h.
The test was stopped when the participant was unable to reach the cone before the next beep.
|
Change from baseline measured by Incremental Shuttle Walk Test distance up to 24 weeks.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Luciana MM Sampaio, PhD, University of Nove de Julho
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Miranda EF, Leal-Junior EC, Marchetti PH, Dal Corso S. Acute effects of light emitting diodes therapy (LEDT) in muscle function during isometric exercise in patients with chronic obstructive pulmonary disease: preliminary results of a randomized controlled trial. Lasers Med Sci. 2014 Jan;29(1):359-65. doi: 10.1007/s10103-013-1359-5. Epub 2013 Jun 7.
- Dourado VZ, Tanni SE, Antunes LC, Paiva SA, Campana AO, Renno AC, Godoy I. Effect of three exercise programs on patients with chronic obstructive pulmonary disease. Braz J Med Biol Res. 2009 Mar;42(3):263-71. doi: 10.1590/s0100-879x2009000300007.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ERAMG-LED-PL-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Motstandstrening
-
Center for Social Innovation, MassachusettsColumbia University; Hunter College of City University of New YorkFullførtHjemløsetjenester | Human Services TrainingForente stater
-
Riphah International UniversityRekrutteringIntegrert motstandstrening | Isolert Resised TrainingPakistan
-
Cardenal Herrera UniversityHar ikke rekruttert ennåMotoriske bilder | Åndedrettsfunksjon | Action Observation Training
-
Methodist Health SystemPåmelding etter invitasjonMock Code Training SimuleringForente stater
-
Autism SpeaksUniversity of California, Los Angeles; Vanderbilt University; Hugo W. Moser...FullførtJoint Engagement + Enhanced Milieu Training | Joint Engagement + Enhanced Milieu Training + Augmentative Communication (AAC)Forente stater
-
University of ThessalyFullførtStyre | Speed Endurance Training Protocol 1 | Speed Endurance Training Protocol 2Hellas
-
Copenhagen Academy for Medical Education and SimulationFullført
-
University of ThessalyAvsluttetPower Training Exercise ProtocolsHellas
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityHar ikke rekruttert ennåAksial forlengelse | Ungdom og barn | Naked Eye 3D Vision Training | Visuell funksjon
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityHar ikke rekruttert ennåPostoperativt delirium | Preoperativ Olfactory Training
Kliniske studier på Light-Emitting Diode Therapy (LEDT)
-
Patricia LordeloUniversity of MessinaRekrutteringAtrofi; VaginalBrasil
-
Centro de Atenção ao Assoalho PélvicoUniversity of Messina; Salvatore Giovanni Vitale M.D.RekrutteringVaginose, bakteriellBrasil
-
Antonio Francesco UrbinoScuola Superiore di Osteopatia ItalianaUkjentHodepine lidelser | Primær hodepinelidelseItalia
-
University of Sao PauloFullførtIdrettsutøvereBrasil
-
University of California, San FranciscoUniversity of MelbourneRekruttering
-
Ohio State University Comprehensive Cancer CenterFullførtAkutt leukemi | Ildfast leukemi | Tilbakevendende leukemiForente stater
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)TilbaketrukketTilbakevendende plateepitelkarsinom i leppe- og munnhulen | Tilbakevendende plateepitelkarsinom i orofarynx | Tilbakevendende verrucous karsinom i munnhulen | Stage I plateepitelkarsinom i leppe- og munnhulen | Stage I plateepitelkarsinom i orofarynx | Stage I Verrucous karsinom i munnhulen | Stage... og andre forholdForente stater
-
Northwell HealthColumbia University; National Library of Medicine (NLM)Fullført
-
Massachusetts General HospitalNational Cancer Institute (NCI); Jawaharlal Nehru Medical CollegeFullført