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Clinical Trials/NCT02571270
NCT02571270
Completed
Not Applicable

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

Universidade Estadual Paulista Júlio de Mesquita Filho0 sites28 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure Patients
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Enrollment
28
Primary Endpoint
Questionnaire about quality of life
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Responsible Party
Principal Investigator
Principal Investigator

Tainá Fabri

Master's degree

Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Outcomes

Primary Outcomes

Questionnaire about quality of life

Time Frame: up to 12 weeks of research

Cardiorespiratory evaluation (VO2 in Mets)

Time Frame: up to 12 weeks of research

Morphological echocardiographic variables (mm)

Time Frame: up to 12 weeks of research

Sistolic Function echocardiographic variables (Percentage)

Time Frame: up to 12 weeks of research

Diastolic Function echocardiographic variables (cm/s)

Time Frame: up to 12 weeks of research

Secondary Outcomes

  • 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)

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