- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02508792
Low Level Laser Therapy in Heart Failure Patients.
Acute Effects of Low Level Laser Therapy in Muscle Function of Patients With Heart Failure.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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RS
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Porto Alegre, RS, 브라질, 90050170
- 모병
- UFCSPA
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연락하다:
- Pedro Dal Lago, Doctor
- 전화번호: +555133038796
- 이메일: pdallago@ufcspa.edu.br
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연락하다:
- Anelise Sonza, Doctor
- 전화번호: +555133038796
- 이메일: anelise.sonza@gmail.com
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부수사관:
- Marilia Lambrecht
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in muscle torque after a fatigue protocol in HF patients
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Pedro Dal Lago, Doctor, Federal University of Health Science of Porto Alegre
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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