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Ventilatory Support Associated With Exercise in Heart Failure (SVNI)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
noninvasive ventilatory support
interval training
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ventilatory support

    interval training

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    SIX MINUTES WALK TEST
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Secondary Outcome Measures

    double product
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    spirometry
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    minnesota questionnaire
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    SF-36 questionnaire
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Functional Independence Measure questionnaire
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.

    Full Information

    First Posted
    February 16, 2015
    Last Updated
    March 4, 2015
    Sponsor
    Federal University of Bahia
    Collaborators
    Hospital Ana Nery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02384798
    Brief Title
    Ventilatory Support Associated With Exercise in Heart Failure
    Acronym
    SVNI
    Official Title
    Noninvasive Ventilatory Support Associated With Concurrent Training in Improved Functional Capacity and Quality of Life in Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Bahia
    Collaborators
    Hospital Ana Nery

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ventilatory support
    Arm Type
    Experimental
    Arm Description
    noninvasive ventilatory support to 5cmH2O used before the session of interval training and resistance exercises performed three times a week for 12 weeks
    Arm Title
    interval training
    Arm Type
    Active Comparator
    Arm Description
    sessions of interval training and resistance exercises performed three times a week for 12 weeks
    Intervention Type
    Other
    Intervention Name(s)
    noninvasive ventilatory support
    Other Intervention Name(s)
    CPAP of redmed brand
    Intervention Description
    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
    Intervention Name(s)
    interval training
    Other Intervention Name(s)
    concurrent training
    Intervention Description
    interval training
    Primary Outcome Measure Information:
    Title
    SIX MINUTES WALK TEST
    Description
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Time Frame
    AFTER 12 WEEKS FOLLOW
    Secondary Outcome Measure Information:
    Title
    double product
    Description
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Time Frame
    AFTER 12 WEEKS FOLLOW
    Title
    spirometry
    Description
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Time Frame
    AFTER 12 WEEKS FOLLOW
    Title
    minnesota questionnaire
    Description
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Time Frame
    AFTER 12 WEEKS FOLLOW
    Title
    SF-36 questionnaire
    Description
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Time Frame
    AFTER 12 WEEKS FOLLOW
    Title
    Functional Independence Measure questionnaire
    Description
    Identifying whether a combined resistance and aerobic exercise program (concurrent training) associated with the use of non-invasive ventilation is effective in improving the quality of life and functional capacity of patients with ventricular dysfunction.
    Time Frame
    AFTER 12 WEEKS FOLLOW

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MANSUETO G NETO
    Organizational Affiliation
    Federal University of Bahia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10987815
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28378600
    Citation
    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.
    Results Reference
    derived

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    Ventilatory Support Associated With Exercise in Heart Failure

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