Chronic Heart Failure
Conditions
Keywords
Home-based exercise, Functional capacity, Chronic Heart Failure
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Instituto Dante Pazzanese de Cardiologia
InCor Heart Institute
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The participants will be randomized in two groups: Home-based and Supervised exercise groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic heart failure (functional class from NYHA II and III), * Left ventricle ejection fraction bellow or equal to 40% * Clinical stability during the last three months * Medical release for physical training after cardiopulmonary test
Exclusion criteria
* Uncontrolled arrhythmia * Pulmonary artery systolic pressure \> 35 mmHg by the echo doppler cardiogram, * Peripheral oxygen saturation \< 92% in resting condition * Respiratory infection in the previous 30 days to the enrollment into the study * Cognitive, neurological or orthopedic limitations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in peak oxygen uptake (ml/kg/min) | Baseline and after 12 weeks of exercise programs | Patients will be submitted to cardiopulmonary treadmill exercise tests at baseline and after 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in distance from the six minute walk test (6MW, m) | Baseline and after 4, 8 and 12 weeks of exercise programs | Patients will be submitted to the 6MW accordingly to the American Thoracic guidelines to assess functional capacity using the six minute walk test |
| Changes in respiratory muscle strength (cmH2O) | Baseline and after 4, 8 and 12 weeks of exercise programs | Inspiratory and expiratory muscle strength will be assessed using an analogic pressure transducer |
| Changes in peripheral muscle strength (N) - Quadriceps mm | Baseline and after 4, 8 and 12 weeks of exercise program | Quadriceps strength will be assessed by MicroFet 2 dynamometer (HogganHealth, USA) |
| Changes in peripheral muscle strength (kgf) - Hand grip | Baseline and after 4, 8 and 12 weeks of exercise programs | Hand grip strength will be assessed by Jamar dynamometer (Sammons Preston Rolyan, 4, Sammons Court, Bolingbrook, IL, 60440) |
| Changes in daily physical activity and sedentary lifestyle | Baseline and after 12 weeks of exercise programs | Patients will use the accelerometer GT3X (Actigraph, Pensacola, FL, USA) on waist during 9 days to asses daily physical activity and sedentary lifestyle |
| Changes in International Physical Activity Questionnaire (IPAQ) | Baseline and after 12 weeks of exercise programs | Patients will be classified as sedentary, irregularly active, active or very active according to Matsudo's Classification (2001) |
| Incidence of cardiac events and arrhythmia | Baseline and after 12 weeks of exercise programs | By a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs |
| Changes in quality of life using MLHF | Baseline and after 12 weeks of exercise programs | Quality of life will be assessed by the Minnesota Living with Heart Failure Questionnaire |
| Changes in brain natriuretic peptide (BNP, pg/mL) | Baseline and after 12 weeks of exercise programs | A blood sample of 5 ml will be collected in a tube and BNP will be measured |
| Changes in heart rate variability (HRV) | Baseline and after 12 weeks of exercise programs | 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 |
| Changes in sleep quality | Baseline and after 12 weeks of exercise programs | 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. |
| Changes in daytime sleepiness | Baseline and after 12 weeks of exercise programs | Daytime sleepiness will be assessed by the Epworth Sleepiness Scale |
| Changes in quality of life using SF-36 | Baseline and after 12 weeks of exercise programs | Quality of life will be assessed by the Short Form-36 Questionnaire |
Countries
Brazil
Contacts
Primary ContactNaomi K Nakagawa, PhD
Backup ContactGeisa N Andrade
Outcome results
None listed