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Completed

NCT Number: NCT04248894

Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

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).

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Institute, São Paulo, Cerqueira Cesar, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training of High Intensity

Other

High intensity

Other names: Physical exercise

Exercise training of Moderate Intensity

Other

Moderate intensity

Untraining

Other

Sedentary

Primary outcomes

  1. Change in muscle sympathetic nerve activity (MSNA)

    Time frame: Baseline and 12 weeks

    MSNA is being assessed by microneurography

  2. Change muscle mechanoreceptor sensitivity

    Time frame: Baseline and 12 weeks

    The mechanoreceptor sensitivity is being assessed via passive exercise to the leg

  3. Change muscle metaboreceptor sensitivity

    Time frame: Baseline and 12 weeks

    The metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.

  4. Change in chemoreceptor sensitivity

    Time frame: Baseline and 12 weeks

    Hypoxia via 10% oxygen

Secondary outcomes

  1. Peripheral vascular function

    Time frame: Baseline and 12 weeks

    Brachial artery flow-mediated dilation is being used to assess the vascular function

  2. Skeletal muscle function

    Time frame: Baseline and 12 weeks

    The skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2023
First posted
Jan 30, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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