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Clinical Trials/NCT02384798
NCT02384798
Completed
Not Applicable

Noninvasive Ventilatory Support Associated With Concurrent Training in Improved Functional Capacity and Quality of Life in Patients With Heart Failure

Federal University of Bahia0 sites60 target enrollmentJanuary 2014
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Federal University of Bahia
Enrollment
60
Primary Endpoint
SIX MINUTES WALK TEST
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
February 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federal University of Bahia
Responsible Party
Principal Investigator
Principal Investigator

Mansueto Gomes Neto

Physiotherapy course coordinator

Federal University of Bahia

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.

Outcomes

Primary Outcomes

SIX MINUTES WALK TEST

Time Frame: AFTER 12 WEEKS FOLLOW

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 Outcomes

  • double product(AFTER 12 WEEKS FOLLOW)
  • spirometry(AFTER 12 WEEKS FOLLOW)
  • minnesota questionnaire(AFTER 12 WEEKS FOLLOW)
  • SF-36 questionnaire(AFTER 12 WEEKS FOLLOW)
  • Functional Independence Measure questionnaire(AFTER 12 WEEKS FOLLOW)

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