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Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Asthmatic Patients

2017年4月9日 更新者:Ivan Peres Costa、University of Nove de Julho

Chronic Effects Using Light-Emitting Diode Therapy (LEDT) During a Resistance Exercise Protocol for Moderate to Severe Asthmatic Patients: a Randomized Controlled Clinical Trial.

The objective of this study is to evaluate the effects of LED phototherapy associated with a resistance training protocol on the peripheral muscle function of moderate to severe asthmatic patients ..

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • São Paulo、ブラジル、05415-012
        • Ivan Peres Costa

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年~50年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
他の名前:
  • photobiomodulation by LEDT
プラセボコンパレーター: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.
他の名前:
  • photobiomodulation by LEDT

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pectoral Muscular Strength by 1RM.
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Capacity by Cardiopulmonary exercise test.
時間枠: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.
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Luciana MM Sampaio, PhD、University of Nove de Julho

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年3月1日

一次修了 (実際)

2015年1月1日

研究の完了 (実際)

2016年12月1日

試験登録日

最初に提出

2016年12月3日

QC基準を満たした最初の提出物

2017年4月9日

最初の投稿 (実際)

2017年4月13日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月13日

QC基準を満たした最後の更新が送信されました

2017年4月9日

最終確認日

2017年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

IPD will not be shared with other researchers since there is no third party interest in the data collected.

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米国FDA規制機器製品の研究

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