Heart FailureNCT01747395
Exercise Training Associated With Inspiratory Muscle Training in Heart Failure
A study testing Exercise training in people with Heart Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Jul 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with systolic heart failure and New York Heart Association (NYHA) class II-III
- Left ventricular ejection fraction less than 40%
- Peak Oxygen Consumption less than 20 ml/Kg/min
Who cannot join
- Chronic Obstructive Pulmonary Disease
- Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases
- Recent myocardial infarction or cardiac surgery (less than 6 months)
- Unstable angina pectoris
- Atrial Fibrillation
- Pacemakers users
Show all 9Show fewer
- Actual Smoker
- Pregnant
- Changing medication or hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure
The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.
Read the detailed description
The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.
- Conditions
- Heart Failure
- Being tested
- Exercise training
- Keywords
- Heart Failure, Exercise and Physical Fitness
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
The heart failure patients are subjected to differents protocols of physical training
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No exercise group (sedentary) |
| Aerobic Exercise Training | Experimental | Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths Receives: Other: Exercise training |
| Inspiratory Muscle Training | Experimental | Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths Receives: Other: Exercise training |
| Aerobic+Inspiratory Muscle Training | Experimental | Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic control
Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.
Measured: 4 months
Secondary outcomes (5)
Functional Capacity
Exercise training associated with inspiratory muscle training will improve peak oxygen consumption
Measured: 4 months
Quality of life
Exercise training associated with inspiratory muscle training will improve quality of life
Measured: 4 months
Blood inflammatory markers
Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers
Measured: 4 months
Muscular evaluation
Exercise training associated with inspiratory muscle training will increase skeletal muscle strength
Measured: 4 months
Respiratoy muscle function
Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2020
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Patricia Fernandes Trevizan, University of Sao Paulo General Hospital
- Investigators
- Carlos Eduardo Negrão, Principal investigator, InCor, HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747395
- Sponsor's protocol ID
- ICRESP814/10
- Status last verified
- Apr 2021
- First submitted
- 6 Dec 2012
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Antunes-Correa LM, Trevizan PF, Bacurau AVN, Ferreira-Santos L, Gomes JLP, Urias U, Oliveira PA, Alves MJNN, de Almeida DR, Brum PC, Oliveira EM, Hajjar L, Kalil Filho R, Negrao CE. Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):89-102. doi: 10.1002/jcsm.12495. Epub 2019 Nov 19.
PubMed 31743617
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01747395
- Acronym / sponsor ID
- ICRESP814/10
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Exercise and Physical Fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Aug 2012
- Primary completion
- Apr 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- 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.
The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.
Detailed description
The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No exercise group (sedentary) |
| Aerobic Exercise Training | Experimental | Other: Exercise trainingGroup undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths |
| Inspiratory Muscle Training | Experimental | Other: Exercise trainingGroup undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths |
| Aerobic+Inspiratory Muscle Training | Experimental | Other: Exercise trainingGroup undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with systolic heart failure and New York Heart Association (NYHA) class II-III
- Left ventricular ejection fraction less than 40%
- Peak Oxygen Consumption less than 20 ml/Kg/min
Key exclusion criteria (9 listed)
- Chronic Obstructive Pulmonary Disease
- Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases
- Recent myocardial infarction or cardiac surgery (less than 6 months)
- Unstable angina pectoris
- Atrial Fibrillation
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 |
|---|---|---|
| Exercise trainingThe heart failure patients are subjected to differents protocols of physical training | Other | Aerobic Exercise Training, Aerobic+Inspiratory Muscle Training, Inspiratory Muscle Training |
Primary outcome
Autonomic control
Time frame: 4 months
Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.
5 secondary outcomes
Functional Capacity
Time frame: 4 months
Quality of life
Time frame: 4 months
Blood inflammatory markers
Time frame: 4 months
Muscular evaluation
Time frame: 4 months
Respiratoy muscle function
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 31743617Antunes-Correa LM, Trevizan PF, Bacurau AVN, Ferreira-Santos L, Gomes JLP, Urias U, Oliveira PA, Alves MJNN, de Almeida DR, Brum PC, Oliveira EM, Hajjar L, Kalil Filho R, Negrao CE. Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):89-102. doi: 10.1002/jcsm.12495. Epub 2019 Nov 19.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Eduardo Negrão principal investigator
InCor, HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Heart Failure, run by University of Sao Paulo General Hospital 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Apr 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?
Autonomic control (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01747395, which also lists 1 linked publication.
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 30 Apr 2021.