Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Other: exercise protocol no supervised; Other: controlled, supervised exercise protocol

• Registration Number: NCT02087670
• Lead Sponsor: Grupo Rehabilitacion en Salud

Brief Summary

Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.

Detailed Description

Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Results First Submitted: 2014-04-22
• Results First Submitted QC: 2014-07-14
• Results First Posted: 2014-08-07
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months

Exclusion Criteria

• patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
community based exercise	exercise protocol no supervised	educational program and not supervises exercise program
controlled, supervised exercise protocol	controlled, supervised exercise protocol	controlled, supervised exercise protocol within a cardiac rehabilitation program

Primary Outcome Measures

Name	Time	Method
Natriuretic Brain Pro-peptid	8 weeks

Secondary Outcome Measures

Name	Time	Method
Oxygen Consumption	8 weeks

Trial Locations

Locations (1)

Universidad de Antioquia; 🇨🇴 Medellín, Antioquia, Colombia