Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. In this way, home physical training may be a good alternative to patients who, for any reason, cannot perform supervised training. Objective: To asses the effects of a home-based training program on functional capacity, sedentary lifestyle and quality of life of patients with chronic HF compared to supervised training.
After agreement with the written informed consent, subjects with heart failure (left ventricle ejection fraction bellow or equal 40%) will be included in this study. They will be randomized in two groups: Home-based and Supervised exercise groups. The two groups will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. All volunteers will be assessed at baseline and after twelve weeks of intervention. Peripheric and respiratory muscle strength as well the 6MW analyses were assessed also at 4 and 8 weeks after baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. They will be randomized in two groups: Home-based and Supervised.
School of Medicine, University of Sao Paulo
São Paulo, São Paulo, Brazil
RECRUITINGInstituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
RECRUITINGChanges in peak oxygen uptake (ml/kg/min)
Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks.
Time frame: Baseline and after 12 weeks of exercise programs
Incidence of cardiac events and arrhythmia
By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs
Time frame: Baseline and after 12 weeks of exercise programs
Changes in distance from the six minute walk test (6MW, m)
Patients will be submitted to the 6MW accordingly to the American Thoracic guidelines to assess functional capacity using the six minute walk test
Time frame: Baseline and after 4, 8 and 12 weeks of exercise programs
Changes in respiratory muscle strength (cmH2O)
Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer
Time frame: Baseline and after 4, 8 and 12 weeks of exercise programs
Changes in peripheral muscle strength (N) - Quadriceps mm
Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA)
Time frame: Baseline and after 4, 8 and 12 weeks of exercise program
Changes in peripheral muscle strength (kgf) - Hand grip
Hand grip strength will be assessed by Jamar dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440)
Time frame: Baseline and after 4, 8 and 12 weeks of exercise programs
Changes in daily physical activity and sedentary lifestyle
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Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on waist during 9 days to asses daily physical activity and sedentary lifestyle
Time frame: Baseline and after 12 weeks of exercise programs
Changes in International Physical Activity Questionnaire (IPAQ)
Patients will be classified as sedentary, irregularly active, active or very active according to Matsudo's Classification (2001)
Time frame: Baseline and after 12 weeks of exercise programs
Changes in quality of life using SF-36
Quality of life will be assessed by the Short Form-36 Questionnaire
Time frame: Baseline and after 12 weeks of exercise programs
Changes in quality of life using MLHF
Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire
Time frame: Baseline and after 12 weeks of exercise programs
Changes in brain natriuretic peptide (BNP, pg/mL)
A blood sample of 5 ml will be collected in a tube and BNP will be measured
Time frame: Baseline and after 12 weeks of exercise programs
Changes in heart rate variability (HRV)
HRV will be analysed from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland) during the 6MW
Time frame: Baseline and after 12 weeks of exercise programs
Changes in sleep quality
Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on wrist for nine days to asses Sleep quality. Furthermore, the Pittsburgh Sleep Quality Index will be used to classify patients as good or poor sleepers.
Time frame: Baseline and after 12 weeks of exercise programs
Changes in daytime sleepiness
Daytime sleepiness will be assessed by the Epworth Sleepiness Scale
Time frame: Baseline and after 12 weeks of exercise programs