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12-Week-Combined Physical Training In Heart Failure Patients

Primary Purpose

Heart Failure Patients

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combined aerobic and resistance physical training program
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure Patients focused on measuring Exercise, quality of life, healthy, cardiac remodeling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Active lifestyle

    Lifestyle counseling

    secondary prevention

    survival

    Arm Description

    Active lifestyle involves nutritional education, physical activity and active recreation.

    Lifestyle counseling helps patients to have better self-care.

    Secondary prevention it is essential to prevent a new unfavorable event.

    The survival of patients with heart failure may increase with exercise training.

    Outcomes

    Primary Outcome Measures

    Questionnaire about quality of life
    Cardiorespiratory evaluation (VO2 in Mets)
    Morphological echocardiographic variables (mm)
    Sistolic Function echocardiographic variables (Percentage)
    Diastolic Function echocardiographic variables (cm/s)

    Secondary Outcome Measures

    Anthropometric measurements (cm)
    Body composition (%fat percentage)
    Presence of comorbidities
    Blood pressure measurement (mmHg)

    Full Information

    First Posted
    October 2, 2015
    Last Updated
    October 6, 2015
    Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02571270
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Estadual Paulista Júlio de Mesquita Filho

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure Patients
    Keywords
    Exercise, quality of life, healthy, cardiac remodeling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active lifestyle
    Arm Type
    Active Comparator
    Arm Description
    Active lifestyle involves nutritional education, physical activity and active recreation.
    Arm Title
    Lifestyle counseling
    Arm Type
    Active Comparator
    Arm Description
    Lifestyle counseling helps patients to have better self-care.
    Arm Title
    secondary prevention
    Arm Type
    Active Comparator
    Arm Description
    Secondary prevention it is essential to prevent a new unfavorable event.
    Arm Title
    survival
    Arm Type
    Active Comparator
    Arm Description
    The survival of patients with heart failure may increase with exercise training.
    Intervention Type
    Other
    Intervention Name(s)
    Combined aerobic and resistance physical training program
    Primary Outcome Measure Information:
    Title
    Questionnaire about quality of life
    Time Frame
    up to 12 weeks of research
    Title
    Cardiorespiratory evaluation (VO2 in Mets)
    Time Frame
    up to 12 weeks of research
    Title
    Morphological echocardiographic variables (mm)
    Time Frame
    up to 12 weeks of research
    Title
    Sistolic Function echocardiographic variables (Percentage)
    Time Frame
    up to 12 weeks of research
    Title
    Diastolic Function echocardiographic variables (cm/s)
    Time Frame
    up to 12 weeks of research
    Secondary Outcome Measure Information:
    Title
    Anthropometric measurements (cm)
    Time Frame
    up to 12 weeks of research
    Title
    Body composition (%fat percentage)
    Time Frame
    up to 12 weeks of research
    Title
    Presence of comorbidities
    Time Frame
    up to 12 weeks of research
    Title
    Blood pressure measurement (mmHg)
    Time Frame
    up to 12 weeks of research

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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    12-Week-Combined Physical Training In Heart Failure Patients

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