Clinical trial NCT02571270: 12-Week-Combined Physical Training In Heart Failure Patients
Official title: Impact Of Supervised 12-Week-Combined Physical Training In Heart Failure Patients: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure Patients
Keywords: Exercise
quality of life
healthy
cardiac remodeling
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Questionnaire about quality of life
timeFrame: up to 12 weeks of research
measure: Cardiorespiratory evaluation (VO2 in Mets)
timeFrame: up to 12 weeks of research
measure: Morphological echocardiographic variables (mm)
timeFrame: up to 12 weeks of research
measure: Sistolic Function echocardiographic variables (Percentage)
timeFrame: up to 12 weeks of research
measure: Diastolic Function echocardiographic variables (cm/s)
timeFrame: up to 12 weeks of research
Secondary outcomes:
measure: Anthropometric measurements (cm)
timeFrame: up to 12 weeks of research
measure: Body composition (%fat percentage)
timeFrame: up to 12 weeks of research
measure: Presence of comorbidities
timeFrame: up to 12 weeks of research
measure: Blood pressure measurement (mmHg)
timeFrame: up to 12 weeks of research
Other outcomes:
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