12-Week-Combined Physical Training In Heart Failure Patients

Study Overview
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Brief Summary
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Purpose: Physical exercise exerts favorable impact on functional capacity (FC) and quality of life (QL) in patients with heart failure (HF). It is believed that the combined aerobic and resistance physical training (CPT) supervised by physical educator is better than only prescription of unsupervised exercise. The aim of this study is to compare the effects of a CPT program on the FC and QL of HF patients with reduced ejection fraction (HFREF) with the practice medical routine prescription of regular physical activity and correlate these findings with clinical and echocardiographic variables. Methods: A longitudinal prospective study included 28 consecutive HFREF patients randomly divided in two age- and gender- matched groups: Trained Group (TG, n = 17), patients undergoing 12 weeks of supervised CPT and Non Trained Group (NTG, n = 11), patients receiving only medical prescription to practice regular physical exercise. All patients were submitted to clinical evaluation, transthoracic echocardiography, Cooper walk test and QL questionnaire before and after the study protocol. Student t test or Mann-Whitney test were performed for groups comparison and correlation tests for the same group variable associations.

Official Title
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Impact Of Supervised 12-Week-Combined Physical Training In Heart Failure Patients: A Randomized Trial

Conditions
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Heart Failure Patients

Intervention / Treatment
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* Other: Combined aerobic and resistance physical training program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with heart failure with LVEF <50%; Patients with optimized drug therapy; Age over 18 years. Exclusion Criteria: Heart failure NYHA class IV and/or Stage D; Decompensated HF in the last three months; Atrial fibrillation and/or implantable device at the moment of inclusion; Patients with chronic obstructive pulmonary disease (COPD); Patients with biomechanical limitations of physical activity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active lifestyle<br>Active lifestyle involves nutritional education, physical activity and active recreation. | Other: Combined aerobic and resistance physical training program<br> <br> |
| Active Comparator: Lifestyle counseling<br>Lifestyle counseling helps patients to have better self-care. | Other: Combined aerobic and resistance physical training program<br> <br> |
| Active Comparator: secondary prevention<br>Secondary prevention it is essential to prevent a new unfavorable event. | Other: Combined aerobic and resistance physical training program<br> <br> |
| Active Comparator: survival<br>The survival of patients with heart failure may increase with exercise training. | Other: Combined aerobic and resistance physical training program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire about quality of life |  | up to 12 weeks of research | 
| Cardiorespiratory evaluation (VO2 in Mets) |  | up to 12 weeks of research | 
| Morphological echocardiographic variables (mm) |  | up to 12 weeks of research | 
| Sistolic Function echocardiographic variables (Percentage) |  | up to 12 weeks of research | 
| Diastolic Function echocardiographic variables (cm/s) |  | up to 12 weeks of research | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements (cm) |  | up to 12 weeks of research | 
| Body composition (%fat percentage) |  | up to 12 weeks of research | 
| Presence of comorbidities |  | up to 12 weeks of research | 
| Blood pressure measurement (mmHg) |  | up to 12 weeks of research | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, quality of life, healthy, cardiac remodeling