12-Week-Combined Physical Training In Heart Failure Patients

Heart Failure Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571270
• Other study ID #: UEPJMF-001
• Status: Completed
• Phase: N/A
• First received: October 2, 2015
• Last updated: October 6, 2015
• Start date: March 2015

Study information

• Verified date: October 2015
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure Patients

Intervention

Other:
• Combined aerobic and resistance physical training program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire about quality of life		up to 12 weeks of research	Yes
Primary	Cardiorespiratory evaluation (VO2 in Mets)		up to 12 weeks of research	Yes
Primary	Morphological echocardiographic variables (mm)		up to 12 weeks of research	Yes
Primary	Sistolic Function echocardiographic variables (Percentage)		up to 12 weeks of research	Yes
Primary	Diastolic Function echocardiographic variables (cm/s)		up to 12 weeks of research	Yes
Secondary	Anthropometric measurements (cm)		up to 12 weeks of research	Yes
Secondary	Body composition (%fat percentage)		up to 12 weeks of research	Yes
Secondary	Presence of comorbidities		up to 12 weeks of research	Yes
Secondary	Blood pressure measurement (mmHg)		up to 12 weeks of research	Yes