Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04248894
Collaborator
(none)
35
2
3
108
17.5
0.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise training of High Intensity
  • Other: Exercise training of Moderate Intensity
  • Other: Untraining
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Impact of High-intensity Interval Training Versus Moderate Continuous Training on Neurovascular Control in Patients With Heart Failure
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: Exercise training of High Intensity
High intensity
Other Names:
  • Physical exercise
  • Experimental: 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

    Other: Exercise training of Moderate Intensity
    Moderate intensity

    Sham Comparator: No training

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

    Other: Untraining
    Sedentary

    Outcome Measures

    Primary Outcome Measures

    1. Change in muscle sympathetic nerve activity (MSNA) [Baseline and 12 weeks]

      MSNA is being assessed by microneurography

    2. Change muscle mechanoreceptor sensitivity [Baseline and 12 weeks]

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

    3. Change muscle metaboreceptor sensitivity [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 [Baseline and 12 weeks]

      Hypoxia via 10% oxygen

    Secondary Outcome Measures

    1. Peripheral vascular function [Baseline and 12 weeks]

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

    2. Skeletal muscle function [Baseline and 12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heart Institute São Paulo Cerqueira Cesar Brazil
    2 Heart Institute (InCor) Sao Paulo SP Brazil 05403-900

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

    • Principal Investigator: Calors Negrao, PhD, aHeart Institute, University of São Paulo Medical School, São Paulo, Brazil

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT04248894
    Other Study ID Numbers:
    • SDC: 4070/14/050
    First Posted:
    Jan 30, 2020
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2022