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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04350541
Other study ID # 07640919.4.0000.5208
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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