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OpenTrials
Completed

NCT Number: NCT02571270

12-Week-Combined Physical Training In Heart Failure Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined aerobic and resistance physical training program

Other

Primary outcomes

  1. Questionnaire about quality of life

    Time frame: up to 12 weeks of research

  2. Cardiorespiratory evaluation (VO2 in Mets)

    Time frame: up to 12 weeks of research

  3. Morphological echocardiographic variables (mm)

    Time frame: up to 12 weeks of research

  4. Sistolic Function echocardiographic variables (Percentage)

    Time frame: up to 12 weeks of research

  5. Diastolic Function echocardiographic variables (cm/s)

    Time frame: up to 12 weeks of research

Secondary outcomes

  1. Anthropometric measurements (cm)

    Time frame: up to 12 weeks of research

  2. Body composition (%fat percentage)

    Time frame: up to 12 weeks of research

  3. Presence of comorbidities

    Time frame: up to 12 weeks of research

  4. Blood pressure measurement (mmHg)

    Time frame: up to 12 weeks of research

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
First posted
Oct 8, 2015
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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