Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD

Heart Failure Clinical Trial

Official title:

Heart Failure Associated With Chronic Obstructive Lung Disease and Maximum Exercise Tolerance: Evaluation of the Distribution and Pulmonary Deposition of Radioaerosol, Peripheral and Coronary Endothelial Function, Brain Natriuretic Peptide

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04350541
• Other study ID #: 07640919.4.0000.5208
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: October 2021
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

INTRODUCTION: The complexity of the pathophysiology of heterogeneous diseases such as heart failure and obstructive pulmonary disease causes a different approach to these diseases or with a view as much as a better understanding of the same situations, with which the clinical profile of patients who are associated with an association is. It is known that regular physical training promotes progressive improvements in exercise tolerance, in the pulmonary ventilation / perfusion ratio and in respiratory function by strengthening. OBJECTIVE: To compare the effects of high-intensity interval training and continuous aerobic exercise, with peripheral endothelial function, brain natriuretic peptide levels, maximum exercise tolerance, distribution of lung volumes and quality of life of patients with obstructive pulmonary disease associated with heart failure. METHODS: This is a clinical, controlled, randomized and blinded trial. Peripheral endothelial function, tolerance to maximum and submaximal exercise, distribution of lung volumes, quality of life, presence of symptoms of depression and perception of clinical change will be evaluated. EXPECTED RESULTS: Incorporate into the care of these patients, new effective therapeutic approaches, of low cost and with greater technical and scientific evidence.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 15, 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Sedentary individuals with Heart Failure of all etiologies;

• Diagnosed moderate and severe chronic obstructive pulmonary disease;

• Clinical stability;

• No change in the medication class within three months before the beginning of the research.

Exclusion Criteria:

• Unstable angina;

• Myocardial infarction;

• Previous cardiac surgery up to three months before the beginning of the study;

• Hemodynamic instability;

• Orthopedic and neurological diseases;

• Psychological and/or mental impairment.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• High-intensity interval training
Exercise with high-intensity intervals followed by active rest
• Continuous aerobic training
Interval Moderate-intensity aerobic training without intervals

Locations

Country	Name	City	State
Brazil	Federal University of Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise tolerance	Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.	24 weeks
Primary	Peripheral endothelial function	Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device	24 weeks
Secondary	Quality of life assessment: Short Form-36 questionnaire	Evaluated by the Short Form-36 questionnaire	24 weeks
Secondary	Perception of clinical change	Evaluated by the Patient Global Impression of Change Scale which is a one-dimensional measure in which individuals can rate their associated improvement on a 7-item scale ranging from "1 = no changes" to "7 = much better".	24 weeks
Secondary	Distance covered in the six-minute walk test	Evaluated by the six-minute walk test	24 weeks