Clinical trial NCT04248894: Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function
Official title: The Impact of High-intensity Interval Training Versus Moderate Continuous Training on Neurovascular Control in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF).

Detailed description: In this study, the investigators are testing the hypothesis that reductions in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF). To test this hypothesis patients with chronic heart failure (30 - 65 years), left ventricular ejection fraction ≤40%, Functional Classes II-III), are being randomized into exercise with HIIT, MICT or no training (NT) three times/week for 12 weeks. Muscle sympathetic nerve activity is assessed by microneurography. Brachial artery flow-mediated dilation (FMD), blood flow and vascular conductance were assessed by ultrasonography. Blood pressure (BP) and heart rate (HR) by are being measured via finger photoplethysmograph and peak oxygen uptake (V̇O2peak) by a cardiopulmonary exercise test on ergometer cycle for leg. Biopsy samples from the lateral vast of the thigh are being collected for analysis of the intracellular mechanisms in the skeletal muscle. Exercise training is being conducted under supervision at the Heart Institute, School of Medicine, University of São Paulo. Both HIIT and MICT are performed on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 Kcal/session). The intensity of the MICT session is established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point (RCP). The intensity of the HIIT session is established based on the HR and workload levels corresponding to 5% above the RCP. All exercise sessions were performed under the supervision of an exercise physiologist. The patients in the NT group were instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study. All patients are being assessed before (pre) and after (post) both exercise training modes or control, no training.

Eligibility criteria: Inclusion Criteria:

* Functional Class II to III of New York Heart Association
* Left ventricular ejection fraction ≤40%
* Peak oxygen uptake (V̇O2) \<20 ml•kg-1•min-1

Exclusion Criteria:

* Myocardial infarction within three months
* Unstable angina
* Acute heart failure
* Pacemaker
* Pulmonary disease
* Chronic renal disease
* Peripheral neuropathy
* History of stroke
* Untreated hypo/hyperthyroidism
* Body mass index (BMI) \>30 kg/m2
* History of smoking

Primary outcomes:
measure: Change in muscle sympathetic nerve activity (MSNA)
timeFrame: Baseline and 12 weeks
measure: Change muscle mechanoreceptor sensitivity
timeFrame: Baseline and 12 weeks
measure: Change muscle metaboreceptor sensitivity
timeFrame: Baseline and 12 weeks
measure: Change in chemoreceptor sensitivity
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Peripheral vascular function
timeFrame: Baseline and 12 weeks
measure: Skeletal muscle function
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute
state: Cerqueira Cesar
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor)
state: SP
Study officials:
affiliation: aHeart Institute, University of São Paulo Medical School, São Paulo, Brazil
name: Calors Negrao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sales ARK, Azevedo LF, Silva TOC, Rodrigues AG, Oliveira PA, Jordao CP, Andrade ACM, Urias U, Guimaraes GV, Bocchi EA, Alves MJNN, Hajjar LA, Filho RK, Grunewald ZI, Martinez-Lemus LA, Padilla J, Negrao CE. High-Intensity Interval Training Decreases Muscle Sympathetic Nerve Activity and Improves Peripheral Vascular Function in Patients With Heart Failure With Reduced Ejection Fraction. Circ Heart Fail. 2020 Aug;13(8):e007121. doi: 10.1161/CIRCHEARTFAILURE.120.007121. Epub 2020 Jul 16. No abstract available.
citation: Xiao P, Wang C, Li J, Su H, Yang L, Wu P, Lewno MT, Liu J, Wang X. COP9 Signalosome Suppresses RIPK1-RIPK3-Mediated Cardiomyocyte Necroptosis in Mice. Circ Heart Fail. 2020 Aug;13(8):e006996. doi: 10.1161/CIRCHEARTFAILURE.120.006996. Epub 2020 Jun 24.