Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

NCT04248894 | Completed

• 1 other identifier: SDC: 4070/14/050
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

• Change in muscle sympathetic nerve activity (MSNA)

  MSNA is being assessed by microneurography

  Baseline and 12 weeks

• Change muscle mechanoreceptor sensitivity

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

  Baseline and 12 weeks

• Change muscle metaboreceptor sensitivity

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

  Baseline and 12 weeks

• Change in chemoreceptor sensitivity

  Hypoxia via 10% oxygen

  Baseline and 12 weeks

Secondary Outcomes (2)

• Peripheral vascular function

  Baseline and 12 weeks

• Skeletal muscle function

  Baseline and 12 weeks

Study Arms (3)

High-intensity interval training (HIIT)

EXPERIMENTAL

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

Moderate-intensity continuous training (MICT)

EXPERIMENTAL

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

No training

SHAM COMPARATOR

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

Other: Untraining

Interventions

Exercise training of High Intensity OTHER

High intensity

Also known as: Physical exercise

High-intensity interval training (HIIT)

Exercise training of Moderate Intensity OTHER

Moderate intensity

Moderate-intensity continuous training (MICT)

Untraining OTHER

Sedentary

No training

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Heart Institute

São Paulo, Cerqueira Cesar, Brazil

Location

Heart Institute (InCor)

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32673501 DERIVED

• 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.

  PMID: 32578441 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Calors Negrao, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: January 1, 2015
• Primary Completion: April 1, 2021
• Study Completion: December 31, 2023
• Last Updated: April 29, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)