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IRCT20200412047045N1 IRCT 2020-08-21 Islamic Azad University Effect of High Intensity Interval Training with Blood Flow Restriction on cardiovascular function of Cardiotoxic patients after Breast Cancer therapy BFR, HIIT Effect of High Intensity Interval Training (HIIT) with Blood Flow Restriction (BFR) on cardiovascular function of Cardiotoxic patients after Breast Cancer therapy(pilot study) 2019-04-27 anticipated 20 Complete https://irct.ir/trial/47650 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Balanced 8 block Randomization and Concealment by Packed in Pack, Blinding description: In this study,Kaatsu cuff use for all four groups patients while training, but only in BFR and BFR+HIIT groups blood restricted with Kaatsu equipment will be applied and participants do not have information about the pressure difference applied by the equipment. also the evaluator of the outcome, the analyzer, the safety and monitoring committee, and the main researcher will be blind , and during this study, only Trainer is not . N/A Condition 1: Cardiotoxicity. Condition 2: Cardiac rehabilitation. Condition 3: Breast Cancer. Intervention 1: Intervention group: High Intensity Interval Training. Intervention 2: Intervention group: Blood Flow Restriction. Intervention 3: Intervention group: High Intensity Interval Training with Blood Flow Restriction. Intervention 4: Control group: Active Control. 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 Sara Adimi
Shahid Rajaee cardiovascular, medical and research center, Valiasr ave, Hashemi Rafsanjani highway
Tehran Iran (Islamic Republic of) 199561433 +98 21 2225 4405 sara_adimi@yahoo.com Islamic Azad University scientific Nasim Naderi
ajaee 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) Iran (Islamic Republic of) Breast Cancer patients Age < 65y Second phase of rehabilitation Without Cardiac diseaes before Cancer Treatment Treatment Drug: Anthracyclines 40 ≤Ejection Fraction≤ 50 Heart failure treatment: Beta blockers, ACEI Permission of Cardiologist Signature of consent letter no limit 65 years Female Conditions that cause the patient, not be able to perform the exercises(Fracture of limbs, pregnancy,…) Symptoms of severe heart failure Sign of recurrence of breast cancer (repeat chemotherapy) I42.7 Y71.1 C50 Cardiomyopathy due to drug and external agent Therapeutic (nonsurgical) and rehabilitative cardiovascular devices associated with adverse incidents Malignant neoplasm of breast Rehabilitation Rehabilitation Rehabilitation Prevention Intervention group: High Intensity Interval Training Intervention group: Blood Flow Restriction Intervention group: High Intensity Interval Training with Blood Flow Restriction Control group: Active Control Cardiovascular function. Timepoint: before intervention and after 12 weeks after intervention. Method of measurement: echocardiography. New York Heart Association (NYHA) Functional Classification. Timepoint: before and after 12 weeks intervention. Method of measurement: the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity. Islamic Azad University Approved 2019-04-27 Rajaie Cardiovascular Medical and Research Center Rajaie cardiovascular medical and research center, valiasr ave,Hashemi Rafsanjani highway Tehran Tehran Iran (Islamic Republic of)