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
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
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
NCT ID
NCT02571270
First Posted
October 2, 2015
Last Updated
October 6, 2015
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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
Learn more about this trial
12-Week-Combined Physical Training In Heart Failure Patients
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