Clinical trial NCT02384798: Ventilatory Support Associated With Exercise in Heart Failure
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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
Collaborators: name: Hospital Ana Nery
First posted: 2015-03-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: SIX MINUTES WALK TEST
timeFrame: AFTER 12 WEEKS FOLLOW
Secondary outcomes:
measure: double product
timeFrame: AFTER 12 WEEKS FOLLOW
measure: spirometry
timeFrame: AFTER 12 WEEKS FOLLOW
measure: minnesota questionnaire
timeFrame: AFTER 12 WEEKS FOLLOW
measure: SF-36 questionnaire
timeFrame: AFTER 12 WEEKS FOLLOW
measure: Functional Independence Measure questionnaire
timeFrame: AFTER 12 WEEKS FOLLOW
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Bahia
name: MANSUETO G NETO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.