Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

NCT ID: NCT01747395

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

No exercise group (sedentary)

Group Type NO_INTERVENTION

No interventions assigned to this group

Aerobic Exercise Training

Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

The heart failure patients are subjected to differents protocols of physical training

Inspiratory Muscle Training

Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

The heart failure patients are subjected to differents protocols of physical training

Aerobic+Inspiratory Muscle Training

Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

The heart failure patients are subjected to differents protocols of physical training

Interventions

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Exercise training

The heart failure patients are subjected to differents protocols of physical training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Actual Smoker
* Pregnant
* Changing medication or hospital admission
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patricia Fernandes Trevizan

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Eduardo Negrão

Role: PRINCIPAL_INVESTIGATOR

InCor, HCFMUSP

Locations

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Instituto do Coração - HC/FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 31743617 (View on PubMed)

Other Identifiers

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ICRESP814/10

Identifier Type: -

Identifier Source: org_study_id

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