Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD
Primary Purpose
Heart Failure, Chronic Obstructive Pulmonary Disease
Status
Suspended
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High-intensity interval training
Continuous aerobic training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- Federal University of Pernambuco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interval training
Continuous training
Arm Description
Interval training will consist of 10 minutes of warm-up between 40-50% of the peak oxygen consumption (VO2peak), followed by four to six repetitions of three-minute intervals between 80-90% of VO2peak and three minutes between 40-50% VO2peak and finally, five minutes of cooling down between 30-40% of VO2peak.
The continuous aerobic training will consist of 10 minutes of warm-up with intensity between 40 and 50% of VO2peak, 20 minutes of conditioning between 60 and 70% of VO2peak and 5 minutes of cooling down between 30 and 40% of VO2peak.
Outcomes
Primary Outcome Measures
Exercise tolerance
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.
Peripheral endothelial function
Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device
Secondary Outcome Measures
Quality of life assessment: Short Form-36 questionnaire
Evaluated by the Short Form-36 questionnaire
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".
Distance covered in the six-minute walk test
Evaluated by the six-minute walk test
Full Information
NCT ID
NCT04350541
First Posted
March 23, 2020
Last Updated
October 4, 2021
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT04350541
Brief Title
Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Suspended
Why Stopped
Study suspended due to COVID-19 pandemic
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interval training
Arm Type
Experimental
Arm Description
Interval training will consist of 10 minutes of warm-up between 40-50% of the peak oxygen consumption (VO2peak), followed by four to six repetitions of three-minute intervals between 80-90% of VO2peak and three minutes between 40-50% VO2peak and finally, five minutes of cooling down between 30-40% of VO2peak.
Arm Title
Continuous training
Arm Type
Active Comparator
Arm Description
The continuous aerobic training will consist of 10 minutes of warm-up with intensity between 40 and 50% of VO2peak, 20 minutes of conditioning between 60 and 70% of VO2peak and 5 minutes of cooling down between 30 and 40% of VO2peak.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training
Intervention Description
Exercise with high-intensity intervals followed by active rest
Intervention Type
Other
Intervention Name(s)
Continuous aerobic training
Intervention Description
Interval Moderate-intensity aerobic training without intervals
Primary Outcome Measure Information:
Title
Exercise tolerance
Description
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.
Time Frame
24 weeks
Title
Peripheral endothelial function
Description
Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Quality of life assessment: Short Form-36 questionnaire
Description
Evaluated by the Short Form-36 questionnaire
Time Frame
24 weeks
Title
Perception of clinical change
Description
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".
Time Frame
24 weeks
Title
Distance covered in the six-minute walk test
Description
Evaluated by the six-minute walk test
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD
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