Heart FailureNCT04350541
Effects of HIIT in Tolerance to Exercise of Individuals With HF and Coexisting COPD
A study testing High-intensity interval training and Continuous aerobic training in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- High-intensity interval training and Continuous aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- High-intensity interval training, Continuous aerobic training
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
Exercise with high-intensity intervals followed by active rest
Continuous aerobic trainingOther
Interval Moderate-intensity aerobic training without intervals
| Study group | Role | What they receive |
|---|---|---|
| Interval training | Experimental | 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. Receives: Other: High-intensity interval training |
| Continuous training | Active comparator | 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. Receives: Other: Continuous aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.
Measured: 24 weeks
Peripheral endothelial function
Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device
Measured: 24 weeks
Secondary outcomes (3)
Quality of life assessment: Short Form-36 questionnaire
Evaluated by the Short Form-36 questionnaire
Measured: 24 weeks
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".
Measured: 24 weeks
Distance covered in the six-minute walk test
Evaluated by the six-minute walk test
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Sep 2019
- Primary completionDec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Why it stopped: Study suspended due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BRUNA THAYS SANTANA DE ARAÚJO, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350541
- Sponsor's protocol ID
- 07640919.4.0000.5208
- Status last verified
- Oct 2021
- First submitted
- 23 Mar 2020
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04350541
- Acronym / sponsor ID
- 07640919.4.0000.5208
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended due to COVID-19 pandemic
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval training | Experimental | Other: High-intensity interval trainingInterval 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. |
| Continuous training | Active comparator | Other: Continuous aerobic trainingThe 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Unstable angina;
- Myocardial infarction;
- Previous cardiac surgery up to three months before the beginning of the study;
- Hemodynamic instability;
- Orthopedic and neurological diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingExercise with high-intensity intervals followed by active rest | Other | Interval training |
| Continuous aerobic trainingInterval Moderate-intensity aerobic training without intervals | Other | Continuous training |
Primary outcome
Exercise tolerance
Time frame: 24 weeks
Evaluated by the cardiopulmonary exercise test by measuring the maximum oxygen consumption.
Peripheral endothelial function
Time frame: 24 weeks
Evaluated by the peripheral arterial tonometry using the EndoPat 2000 device
3 secondary outcomes
Quality of life assessment: Short Form-36 questionnaire
Time frame: 24 weeks
Perception of clinical change
Time frame: 24 weeks
Distance covered in the six-minute walk test
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Continuous aerobic training in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.