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IRCT20191207045638N1 IRCT 2019-12-10 Islamic Azad University photobiomodulation therapy(low level LASER therapy) in heart failure The effects of photobiomodulation therapy(low level LASER therapy) on functional capacity and quality of life of patients with heart failure reduced ejection fraction who are on cardiac rehabilitation programs : (double blind randomized ) 2019-08-23 anticipated 30 Complete https://irct.ir/trial/44021 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The sample volume was calculated after a pilot trial on 5 heart failure patients .The aim in the pilot study was 6 minutes walk test distance which was increased from a mean of 300±48 meter to 470±60 meter after low level LASER therapy .The calculated sample volume considering two mean±SD,alpha=1% power 97% ,was about 12 patients and 15 patient was chosen for each group, Randomization description: The randomization will be performed through block randomization, and allocation secrecy will be kept by numbered, opaque, sealed envelopes, Blinding description: The code from the drawing of the study will be given to a care provider that set the unit to either active low level LASER therapy or placebo LASER mode; thus, the study will be conducted in a double blinded placebo-controlled manner, both to the participants and to the investigator,out come assessor and data analyser. 3 Heart failure reduced ejection fraction. Intervention 1: Intervention group: َActive LASER group(n=15)The intervention group will received low level LASER therapy ( LASER device: GALALAS,650nm,5Mw) before sub maximal aerobic exercise(cycle) , laser therapy is applied (150 J/cm2 per point) at 6 points on forearm at acupuncture points( PC6-PC7-HR4-HR5-HR6,ulnar artery acupuncture point) for 20 minutes. Intervention 2: Control group: ) placebo low level LASER therapy group (n=15)—subjects who will be submitted to placebo laser after 20 minutes LASER/placebo therapy .In the placebo group the LASER system will remain off -state. Yes - There is a plan to make this available What will be shared: The primary and secondary out come measures can be shared after completion the trial and publishing the study results When: The data will be available after completion the trial and publishing the study results ( January 2021) To whom: for people working in academic institutions or people working in businesses can also apply to receive it. Conditions: For performing the secondary studies such as systematic reviews Where to obtain: the email address How to obtain: The request should be sent by email and the applicant will receive the data within a month Comments:
public Homa Bahrami
Science and Research Branch,shodada Hesarak blvd, Daneshgah Square,Sattari Highway,Tehran, I.R. IRAN;
Tehran Iran (Islamic Republic of) 1477893855 +98 21 8249 9612 bahramihoma4@gmail.com Islamic Azad University scientific Nasim Naderi
Rajaie cardiovascular medical and research center,Valiasr ave,Hashemi Rafsanjani highway
Tehran Iran (Islamic Republic of) 1995614331 +98 21 2392 2115 naderi.nasim@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Expressed readiness to comply with all study procedures and availability for the duration of the study Provision of dated and signed informed consent form Age 18-65 years A diagnosis of heart failure reduced ejection fraction (LVEF≤ 40%) due to ischemic or non-ischemic etiology Optimal guideline directed medical therapies including angiotensin-converting enzymeinhibitors, β-blockers, aldosterone antagonists, and diuretics for at least 3 months NewYork Heart association function class (NYHA Class) II-III 18 years 65 years Both History of hospitalization for any cause including acute heart failure in preceding month presence Chronic renal failure or dialysis presence of chronic hepatic failure presence of neuromuscular disorders Presence of severe chronic pulmonary disease The patients who have pace maker, intracardiac defibrillator (ICD)or cardiac resynchronization therapy(CRT) psychiatric conditions inability to perform 6 minutes walk test Cardiomyopathy secondary to cancer therapy Presence of any hematologic , Rheumatologic disorder I50 Heart failure Treatment - Other Placebo Intervention group: َActive LASER group(n=15)The intervention group will received low level LASER therapy ( LASER device: GALALAS,650nm,5Mw) before sub maximal aerobic exercise(cycle) , laser therapy is applied (150 J/cm2 per point) at 6 points on forearm at acupuncture points( PC6-PC7-HR4-HR5-HR6,ulnar artery acupuncture point) for 20 minutes Control group: ) placebo low level LASER therapy group (n=15)—subjects who will be submitted to placebo laser after 20 minutes LASER/placebo therapy .In the placebo group the LASER system will remain off -state NewYork Heart Association functional class, Physical performance( 6 minutes walk test distance). Timepoint: Before intervention and after completion of intervention. Method of measurement: 1-New York heart association(NYHA) measurement :NYHA scores range from I (no symptoms of heart failure ) to IV (symptoms at rest) 2- Physical performance of patients was assessed using the 6‐minute walk test (6MWT) according to the protocol of Guyatt and colleagues. Serum level of N terminal pro -brain natreuretic peptide. Timepoint: before intervention and at the intervention completion. Method of measurement: enzyme immunoassay. Quality of life. Timepoint: before intervention and at the intervention completion. Method of measurement: Iranian quality of life questionnaire (IHF-QOL). Echocardiographic data: left ventricular ejection fraction ,Left ventircular end diastolic and systolic dimentions,left ventricular global longitudinal strain. Timepoint: before intervention and at the intervention completion. Method of measurement: Echocardiographic machine. Islamic Azad University Approved 2018-07-08 ethic committee of science and research branch of Islamic Azad university, Tehran/Iran Science and Research Branch,shodada Hesarak blvd, Daneshgah Square,Sattari Highway,Tehran, I.R. IRAN Tehran Tehran Iran (Islamic Republic of)