Low Level Laser Therapy in Heart Failure Patients.
Acute Effects of Low Level Laser Therapy in Muscle Function of Patients With Heart Failure.
調査の概要
詳細な説明
Day 1: Informed Consent signature and Clear (IC); Application of the Minnesota Living with Heart Failure Questionnaire (MLHFQ); Measurement of the muscle thickness with use of ultrasound; Anatomical points definition for electrode placement of Electromyography (EMG); Warming up on stationary bike; Subject's position in the Isokinetic, placement of EMG electrodes and NIRS´ optodes; Baseline measurement (peak torque and muscle fatigue protocol); Stretching exercises for the lower limbs muscles; 48-hour interval.
Day 2: Warming up on stationary bike; LASER / Placebo application; Subject's position in the Isokinetic, placement of EMG electrodes and NIRS´ optodes; Peak torque and muscle fatigue protocol in the Isokinetic equipment; Stretching exercises for the lower limbs muscles; 48-hour interval.
Day 3: Warming up on stationary bike; LASER / Placebo application; Subject's position in the Isokinetic, placement of EMG electrodes and NIRS´ optodes; Peak torque and muscle fatigue protocol in the Isokinetic equipment; Stretching exercises for the lower limbs muscles.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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RS
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Porto Alegre、RS、ブラジル、90050170
- 募集
- UFCSPA
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コンタクト:
- Pedro Dal Lago, Doctor
- 電話番号:+555133038796
- メール:pdallago@ufcspa.edu.br
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コンタクト:
- Anelise Sonza, Doctor
- 電話番号:+555133038796
- メール:anelise.sonza@gmail.com
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副調査官:
- Marilia Lambrecht
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Participants who consent to cooperate with this study and meet the following inclusion criteria: a) to have a clinical diagnosis of heart failure (ejection fraction of the left ventricle less than 40% secondary to ischemia or idiopathic dilated cardiomyopathy) functional class II or III, according to the NYHA classification ; b) be medically stable in the 30 days prior to enrollment in the study and, c) not have participated or are participating in cardiac rehabilitation program.
Exclusion Criteria:
- The sample shall be excluded: a) participants who did not consent to participate in the study, b) participants with present insufficient level of understanding for the tests, c) participants that are making use of anti-inflammatory drugs steroids and nonsteroidal, d) the ones that have limitations to perform physical activity (exacerbation of fatigue, extreme breathlessness, arthritis, claudication, angina), e) participants with musculoskeletal disease, brain vascular disease and psychiatric illness and f) the ones who not adhere to the schedule of activities proposed in the study.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- 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 |
|---|---|
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アクティブコンパレータ:LASER
Subject will receive application of LASER before muscle fatigue protocol. Note: this is a crossover study. |
Low level LASER therapy will be applied in six different regions of the thight from the dominant limb, before a fatigue protocol using a isokinetic equipment.
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プラセボコンパレーター:LASER PLACEBO
Subject will receive application of LASER (now deactivated) before muscle fatigue protocol. Note: this is a crossover study. |
The low level LASER therapy turned off (placebo) will be applied in six different regions of the thight from the dominant limb, before a fatigue protocol using a isokinetic equipment.
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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 |
|---|---|---|
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Change in muscle torque after a fatigue protocol in HF patients
時間枠:8 days
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Muscle torque with an isokinetic equipment will be accessed after a fatigue protocol in patients with heart failure.
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8 days
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協力者と研究者
捜査官
- 主任研究者:Pedro Dal Lago, Doctor、Federal University of Health Science of Porto Alegre
出版物と役立つリンク
一般刊行物
- Leal Junior EC, Lopes-Martins RA, Dalan F, Ferrari M, Sbabo FM, Generosi RA, Baroni BM, Penna SC, Iversen VV, Bjordal JM. Effect of 655-nm low-level laser therapy on exercise-induced skeletal muscle fatigue in humans. Photomed Laser Surg. 2008 Oct;26(5):419-24. doi: 10.1089/pho.2007.2160.
- Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.
- Albuquerque-Pontes GM, Vieira RP, Tomazoni SS, Caires CO, Nemeth V, Vanin AA, Santos LA, Pinto HD, Marcos RL, Bjordal JM, de Carvalho Pde T, Leal-Junior EC. Effect of pre-irradiation with different doses, wavelengths, and application intervals of low-level laser therapy on cytochrome c oxidase activity in intact skeletal muscle of rats. Lasers Med Sci. 2015 Jan;30(1):59-66. doi: 10.1007/s10103-014-1616-2. Epub 2014 Jun 24.
- 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.
- Blum A. Heart failure--new insights. Isr Med Assoc J. 2009 Feb;11(2):105-11.
- Conraads VM, Van Craenenbroeck EM, De Maeyer C, Van Berendoncks AM, Beckers PJ, Vrints CJ. Unraveling new mechanisms of exercise intolerance in chronic heart failure: role of exercise training. Heart Fail Rev. 2013 Jan;18(1):65-77. doi: 10.1007/s10741-012-9324-0.
- Lima A, Bakker J. Near-infrared spectroscopy for monitoring peripheral tissue perfusion in critically ill patients. Rev Bras Ter Intensiva. 2011 Sep;23(3):341-51. English, Portuguese.
- Neves EB, et al. Comparação do percentual de gordura obtido por bioimpedância, ultrasson e dobras cutâneas em adultos jovens. Rev Bras Med Esporte 19(5): 323-327, 2013.
- Rondelli RR, Dal Corso S, Simoes A, Malaguti C. Methods for the assessment of peripheral muscle fatigue and its energy and metabolic determinants in COPD. J Bras Pneumol. 2009 Nov;35(11):1125-35. doi: 10.1590/s1806-37132009001100011. English, Portuguese.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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