Low Level Laser Therapy in Heart Failure Patients.

NCT02508792 | Unknown

• 1 other identifier: 37904814.0.0000.5345
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure (HF) is an important public health problem being considered an emerging epidemic, therefore, strategies are essential to improve symptoms and to decrease the money expenditure on healthcare. Based on the knowledge about the syndrome of heart failure, new approaches are needed to decrease the symptoms, to enhance the quality of life of these patients and highlight the non-pharmacological therapies such as the use of phototherapy. The objective of this study is to study the effect of low level laser therapy in muscle function and tissue oxygenation of the lower limbs in patients with heart failure. It is a randomized, double-blind, including 20 individuals with heart failure, with stable, class II or III according to the New York Heart Association (NYHA). It will be evaluated the acute effects of a LASER intervention applied before a fatigue protocol throught muscle function and tissue oxygenation in the participants. Evaluations will be performed by an isokinetic dynamometer, near infrared spectroscopy (NIRS) and electromyography . It will be analyzed the concentration of oxyhemoglobin and deoxyhemoglobin, total hemoglobin concentration, the difference between these concentrations, muscular torque, fatigue index and muscle activation. The data will be subjected to distribution normality test and if they have normal distribution, the differences between the interventions will be checked by analysis of variance, considering significant ap \<0.05. If the data is non-parametric distribution will be using the Mann-Whitney or Kruskal-Wallis. The SPSS 19.0 software will be used as a tool for data analysis. The investigators expected to find as outcomes of this study an increase in peripheral muscle function and tissue oxygenation and also a delay in the development of muscle fatigue in patients with HF submitted to acute intervention with LASER.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in muscle torque after a fatigue protocol in HF patients

  Muscle torque with an isokinetic equipment will be accessed after a fatigue protocol in patients with heart failure.

  8 days

Study Arms (2)

LASER

ACTIVE COMPARATOR

Subject will receive application of LASER before muscle fatigue protocol. Note: this is a crossover study.

Device: LASER

LASER PLACEBO

PLACEBO COMPARATOR

Subject will receive application of LASER (now deactivated) before muscle fatigue protocol. Note: this is a crossover study.

Device: LASER PLACEBO

Interventions

LASER DEVICE

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.

LASER

LASER PLACEBO DEVICE

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.

LASER PLACEBO

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

UFCSPA

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

RECRUITING

Related Publications (9)

• 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.

  PMID: 24957189 BACKGROUND

• 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.

  PMID: 20602109 BACKGROUND

• Blum A. Heart failure--new insights. Isr Med Assoc J. 2009 Feb;11(2):105-11.

  PMID: 19432040 BACKGROUND

• 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.

  PMID: 19838469 BACKGROUND

• 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.

  PMID: 22684340 BACKGROUND

• 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.

  PMID: 18817474 BACKGROUND

• 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.

  PMID: 23949407 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20011849 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Lasers

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Pedro Dal Lago, Doctor

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Dal Lago, Doctor

CONTACT

33038796; pdallago@ufcspa.edu.br

Anelise Sonza, Doctor

CONTACT

83400864; anelise.sonza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 27, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

BR (1)