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Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

The Impact of High-intensity Interval Training Versus Moderate Continuous Training on Neurovascular Control in Patients With Heart Failure

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04248894
Enrollment
35
Registered
2020-01-30
Start date
2015-01-01
Completion date
2023-12-31
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

OTHERExercise training of High Intensity

High intensity

OTHERExercise training of Moderate Intensity

Moderate intensity

OTHERUntraining

Sedentary

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle sympathetic nerve activity (MSNA)Baseline and 12 weeksMSNA is being assessed by microneurography
Change muscle mechanoreceptor sensitivityBaseline and 12 weeksThe mechanoreceptor sensitivity is being assessed via passive exercise to the leg
Change muscle metaboreceptor sensitivityBaseline and 12 weeksThe metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.
Change in chemoreceptor sensitivityBaseline and 12 weeksHypoxia via 10% oxygen

Secondary

MeasureTime frameDescription
Peripheral vascular functionBaseline and 12 weeksBrachial artery flow-mediated dilation is being used to assess the vascular function
Skeletal muscle functionBaseline and 12 weeksThe skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.

Countries

Brazil

Contacts

PRINCIPAL_INVESTIGATORCalors Negrao, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026