Ventilatory Support Associated With Exercise in Heart Failure

NCT ID: NCT02384798

Last Updated: 2015-03-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-02-28

Brief Summary

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Due to the symptoms of heart failure (HF), as dyspnea and fatigue, patients have a reduced functional capacity, evidenced during usual daily activities and exercises. The Cardiac Rehabilitation with emphasis on resistance and aerobic exercises performed in the same session (concurrent training), can be added to pharmacological treatment as improvement strategy in functional capacity and quality of life.

Detailed Description

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A randomized clinical trial, divided into two stages will be held. In step 1 the function will be assessed by the 6-minute walk test, spirometry, and questionnaires to evaluate quality of life. After fulfilled the series of assessments individuals will be randomly divided into two groups, with group 1 (control) will hold only one interval aerobic exercise program on treadmill and group 2 (intervention) will hold a combined exercise program for prior use of ventilatory support noninvasive. For both groups will be held an aerobic exercise program associated with resistance exercise for 12 weeks. The first two weeks will be considered in period. In the 10 weeks following both groups maintain the preset exercise program gradually. In the intervention group will be added before the exercise program the use of noninvasive ventilation for 30 minutes.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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ventilatory support

noninvasive ventilatory support to 5cmH2O used before the session of interval training and resistance exercises performed three times a week for 12 weeks

Group Type EXPERIMENTAL

noninvasive ventilatory support

Intervention Type OTHER

noninvasive ventilatory support with 5-minute ramp and positive end expiratory pressure (PEEP) of 5 cm H2O for 30 minutes, then there will be the interval aerobic training on a treadmill added to resistance exercises

interval training

Intervention Type OTHER

interval training

interval training

sessions of interval training and resistance exercises performed three times a week for 12 weeks

Group Type ACTIVE_COMPARATOR

interval training

Intervention Type OTHER

interval training

Interventions

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noninvasive ventilatory support

noninvasive ventilatory support with 5-minute ramp and positive end expiratory pressure (PEEP) of 5 cm H2O for 30 minutes, then there will be the interval aerobic training on a treadmill added to resistance exercises

Intervention Type OTHER

interval training

interval training

Intervention Type OTHER

Other Intervention Names

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CPAP of redmed brand concurrent training

Eligibility Criteria

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Inclusion Criteria

* Will be included 60 patients of both sexes, adults with medical diagnosis divided into two groups: Group A consisted of 30 patients use non-invasive ventilation added to interval training and group B consisted of 30 patients also only use interval training.

Exclusion Criteria

* Will be excluded from the study patients who have chest pain (angina), arrhythmias, spo2 ≤ 90%, hypertension or hypotension, neurological or osteoarticular disease preventing the ambulation of these individuals.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Ana Nery

OTHER

Sponsor Role collaborator

Federal University of Bahia

OTHER

Sponsor Role lead

Responsible Party

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Mansueto Gomes Neto

Physiotherapy course coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MANSUETO G NETO

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

References

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Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x.

Reference Type RESULT
PMID: 10987815 (View on PubMed)

Bittencourt HS, Cruz CG, David BC, Rodrigues E Jr, Abade CM, Junior RA, Carvalho VO, Dos Reis FBF, Gomes Neto M. Addition of non-invasive ventilatory support to combined aerobic and resistance training improves dyspnea and quality of life in heart failure patients: a randomized controlled trial. Clin Rehabil. 2017 Nov;31(11):1508-1515. doi: 10.1177/0269215517704269. Epub 2017 Apr 5.

Reference Type DERIVED
PMID: 28378600 (View on PubMed)

Other Identifiers

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FUBahia914311

Identifier Type: -

Identifier Source: org_study_id

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