12-Week-Combined Physical Training In Heart Failure Patients

NCT ID: NCT02571270

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31

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.

Conditions

Heart Failure Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active lifestyle

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

Group Type: ACTIVE_COMPARATOR

Combined aerobic and resistance physical training program

Intervention Type: OTHER

Lifestyle counseling

Lifestyle counseling helps patients to have better self-care.

Group Type: ACTIVE_COMPARATOR

Combined aerobic and resistance physical training program

Intervention Type: OTHER

secondary prevention

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

Group Type: ACTIVE_COMPARATOR

Combined aerobic and resistance physical training program

Intervention Type: OTHER

survival

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

Group Type: ACTIVE_COMPARATOR

Combined aerobic and resistance physical training program

Intervention Type: OTHER

Interventions

Combined aerobic and resistance physical training program

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Tainá Fabri

Master's degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UEPJMF-001

Identifier Type: -

Identifier Source: org_study_id