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
About this trial
This is an interventional treatment trial for Heart Failure
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.
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
NCT ID
NCT02384798
First Posted
February 16, 2015
Last Updated
March 4, 2015
Sponsor
Federal University of Bahia
Collaborators
Hospital Ana Nery
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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