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Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

Primary Purpose

Heart Failure

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training of High Intensity
Exercise training of Moderate Intensity
Untraining
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Institute
  • Heart Institute (InCor)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

High-intensity interval training (HIIT)

Moderate-intensity continuous training (MICT)

No training

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Change in muscle sympathetic nerve activity (MSNA)
MSNA is being assessed by microneurography
Change muscle mechanoreceptor sensitivity
The mechanoreceptor sensitivity is being assessed via passive exercise to the leg
Change muscle metaboreceptor sensitivity
The metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.
Change in chemoreceptor sensitivity
Hypoxia via 10% oxygen

Secondary Outcome Measures

Peripheral vascular function
Brachial artery flow-mediated dilation is being used to assess the vascular function
Skeletal muscle function
The skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.

Full Information

First Posted
January 23, 2020
Last Updated
May 17, 2022
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04248894
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training (HIIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate-intensity continuous training (MICT)
Arm Type
Experimental
Arm Description
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
Arm Title
No training
Arm Type
Sham Comparator
Arm Description
The patients are instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study.
Intervention Type
Other
Intervention Name(s)
Exercise training of High Intensity
Other Intervention Name(s)
Physical exercise
Intervention Description
High intensity
Intervention Type
Other
Intervention Name(s)
Exercise training of Moderate Intensity
Intervention Description
Moderate intensity
Intervention Type
Other
Intervention Name(s)
Untraining
Intervention Description
Sedentary
Primary Outcome Measure Information:
Title
Change in muscle sympathetic nerve activity (MSNA)
Description
MSNA is being assessed by microneurography
Time Frame
Baseline and 12 weeks
Title
Change muscle mechanoreceptor sensitivity
Description
The mechanoreceptor sensitivity is being assessed via passive exercise to the leg
Time Frame
Baseline and 12 weeks
Title
Change muscle metaboreceptor sensitivity
Description
The metaboreceptor sensitivity is being assessed via dynamic exercise to the leg.The exercise intensity is 30% maximum voluntary contraction.
Time Frame
Baseline and 12 weeks
Title
Change in chemoreceptor sensitivity
Description
Hypoxia via 10% oxygen
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Peripheral vascular function
Description
Brachial artery flow-mediated dilation is being used to assess the vascular function
Time Frame
Baseline and 12 weeks
Title
Skeletal muscle function
Description
The skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Calors Negrao, PhD
Organizational Affiliation
aHeart Institute, University of São Paulo Medical School, São Paulo, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute
City
São Paulo
State/Province
Cerqueira Cesar
Country
Brazil
Facility Name
Heart Institute (InCor)
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32673501
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.
Results Reference
derived
PubMed Identifier
32578441
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.
Results Reference
derived

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Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

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