Impact of Interval Training on Sympathetic Hyperactivity and Vascular Function

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04248894
• Other study ID #: SDC: 4070/14/050
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2023
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Functional Class II to III of New York Heart Association

• Left ventricular ejection fraction =40%

• Peak oxygen uptake (V?O2) <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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Exercise training of High Intensity
High intensity
• Exercise training of Moderate Intensity
Moderate intensity
• Untraining
Sedentary

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor)	Sao Paulo	SP
Brazil	Heart Institute	São Paulo	Cerqueira Cesar

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle sympathetic nerve activity (MSNA)	MSNA is being assessed by microneurography	Baseline and 12 weeks
Primary	Change muscle mechanoreceptor sensitivity	The mechanoreceptor sensitivity is being assessed via passive exercise to the leg	Baseline and 12 weeks
Primary	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
Primary	Change in chemoreceptor sensitivity	Hypoxia via 10% oxygen	Baseline and 12 weeks
Secondary	Peripheral vascular function	Brachial artery flow-mediated dilation is being used to assess the vascular function	Baseline and 12 weeks
Secondary	Skeletal muscle function	The skeletal muscle function is being assessed in biopsy samples collected in lateral vasts of thigh with needle of biopsy.	Baseline and 12 weeks