12-Week-Combined Physical Training In Heart Failure Patients

NCT02571270 | Completed

• 1 other identifier: UEPJMF-001
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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

Keywords

Exercise; quality of life; healthy; cardiac remodeling

Outcome Measures

Primary Outcomes (5)

• Questionnaire about quality of life

  up to 12 weeks of research

• Cardiorespiratory evaluation (VO2 in Mets)

  up to 12 weeks of research

• Morphological echocardiographic variables (mm)

  up to 12 weeks of research

• Sistolic Function echocardiographic variables (Percentage)

  up to 12 weeks of research

• Diastolic Function echocardiographic variables (cm/s)

  up to 12 weeks of research

Secondary Outcomes (4)

• 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

Study Arms (4)

Active lifestyle

ACTIVE COMPARATOR

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

Other: Combined aerobic and resistance physical training program

Lifestyle counseling

ACTIVE COMPARATOR

Lifestyle counseling helps patients to have better self-care.

Other: Combined aerobic and resistance physical training program

secondary prevention

ACTIVE COMPARATOR

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

Other: Combined aerobic and resistance physical training program

survival

ACTIVE COMPARATOR

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

Other: Combined aerobic and resistance physical training program

Interventions

Combined aerobic and resistance physical training program OTHER

Active lifestyle; Lifestyle counseling; secondary prevention; survival

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with heart failure with LVEF \<50%;
• Patients with optimized drug therapy;
• Age over 18 years.

You may not qualify if:

• Heart failure NYHA class IV and/or Stage D;
• Decompensated HF in the last three months;
• Patients with chronic obstructive pulmonary disease (COPD);
• Patients with biomechanical limitations of physical activity.

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 8, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2015
• Last Updated: October 8, 2015

Record last verified: 2015-10