12-Week-Combined Physical Training In Heart Failure Patients

October 6, 2015 updated by: Tainá Fabri, Universidade Estadual Paulista Júlio de Mesquita Filho

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEPJMF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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