Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

NCT ID: NCT04248894

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2023-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High-intensity interval training (HIIT)

High-intensity interval training (HIIT) = the exercise of high intensity perform 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 HIIT session was established based on the HR and workload levels corresponding to 5% above the respiratory compensation point.

Group Type: EXPERIMENTAL

Exercise training of High Intensity

Intervention Type: OTHER

High intensity

Moderate-intensity continuous training (MICT)

Moderate-intensity continuous training (MICT) = the exercise of moderate intensity perform 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 was established based on the HR and workload levels corresponding to anaerobic threshold and respiratory compensation point

Group Type: EXPERIMENTAL

Exercise training of Moderate Intensity

Intervention Type: OTHER

Moderate intensity

No training

The patients are instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study.

Group Type: SHAM_COMPARATOR

Untraining

Intervention Type: OTHER

Sedentary

Interventions

Exercise training of High Intensity

High intensity

Intervention Type: OTHER

Exercise training of Moderate Intensity

Moderate intensity

Intervention Type: OTHER

Untraining

Sedentary

Intervention Type: OTHER

Other Intervention Names

Physical exercise

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calors Negrao, PhD

Role: PRINCIPAL_INVESTIGATOR

aHeart Institute, University of São Paulo Medical School, São Paulo, Brazil

Locations

Heart Institute

São Paulo, Cerqueira Cesar, Brazil

Heart Institute (InCor)

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32673501 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32578441 (View on PubMed)

Other Identifiers

SDC: 4070/14/050

Identifier Type: -

Identifier Source: org_study_id