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| ID | Type | Description | Link |
|---|---|---|---|
| FAPESP 2013/13598-1 | Other Grant/Funding Number | Fundação de Amparo à Pesquisa do Estado de São Paulo |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Instituto Dante Pazzanese de Cardiologia | OTHER |
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Heart failure is a clinical syndrome that is the common end of several cardiac diseases with symptoms such as muscle fatigue, dyspnea and reduction of quality of life. To improve respiratory and general functional capacity of these patients, there are strategies that can be used such as inspiratory muscle training and peripheral muscle training (dynamic resistance training).
After agreement with the written informed consent, 35 subjects with severe heart failure were included in this study. They were randomized in three groups: controls, low-intensity and moderate-intensity group. All volunteers were assessed at Baseline and 8-weeks intervention. Cardiac events were registered following two years from baseline. The present study aimed to assess the effects of a combined program of inspiratory and peripheral muscle training on respiratory and general functional capacity and quality of life in patients with chronic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | patients awaiting for evaluation to cardiac rehabilitation or transplantation |
|
| moderate-intensity group | Experimental | Patients will be submitted to a 8-weeks training program, with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with upper and lower exercises (50% of the 1-maximum repetition test). |
|
| low-intensity group | Active Comparator | Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) and peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 Kg each). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| control | Other | No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in respiratory muscle strength (in centimeters of water) | Inspiratory and expiratory muscle strength was assessed by using a pressure transducer (MVD-300 Microhard System, GlobalMed, Porto Alegre, Brazil). | Before and after 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| walking distance | To assess functional capacity using walking distance (6-min walk test accordingly to ATS and ERS guidelines) | Before and after 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pulmonary function | Pulmonary function will be assessed by spirometry. | Before and after 8-weeks |
| Change in functional capacity | 1RM |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi K Nakagawa, PhD | USP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | 04012-909 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2016 | |
| Reset | Jul 20, 2016 | |
| Release | Oct 4, 2016 | |
| Reset | Nov 22, 2016 | |
| Release | Apr 17, 2018 | |
| Reset | Nov 9, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2016 | Jul 20, 2016 | |||
| Oct 4, 2016 |
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| moderate-intensity group | Other | Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks). |
|
| low-intensity group | Other | Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each) |
|
| Before and after 8-weeks |
| Inflammation in the upper airway by cytokines in blood | MMP2, myoglobin, p-selectin, MPO, NGAL, sVCAM, IL-2, IL-3, IL-4, IL-8,MIP1-alpha, 17, VEGF by Multiplex analysis. Inflammatory cells in nasal lavage will be also investigated. | Before and after 8-weeks |
| Change in heart rate variability (HRV) | HRV is obtained from the spectral analysis of R-R intervals obtained from a heart rate monitor (Polar, S810, Kempele, Finland) | Before and after 8-weeks |
| Prevalence of cardiac events and arrhythmia | by a 24-hours holter system for continuous recording of ambulatory electrocardiographic signs | Before and after 8-weeks |
| Change in international Physical Activity Questionnaire (IPAQ) | Patients will be classified as sedentary, irregularly active, active or verry active according to Matsudo's classification (2001). | Before and after 8-weeks |
| Change in quality of life using Minnesota Questionnaire | by Short Form-36 and by Minnesota Living with Heart Failure Questionnaire - Minnesota living with heart failure questionaire: contains 21 questions of physical, social, economic and emotional aspects. Each question ranges from zero to five points, with a total score of 105 points which is the maximum severity degree related to personal perception of quality of life. | Before and after 8-weeks |
| Change in brain natriuretic peptide (BNP) analysis | A blood sample of 5 ml will be collected in a tube and BNP measured | Before and after 8-weeks |
| Nov 22, 2016 |
| Apr 17, 2018 | Nov 9, 2018 |