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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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controlled, supervised exercise protocol

controlled, supervised exercise protocol within a cardiac rehabilitation program

Group Type ACTIVE_COMPARATOR

controlled, supervised exercise protocol

Intervention Type OTHER

exercise program within a cardiac rehabilitation program

community based exercise

educational program and not supervises exercise program

Group Type PLACEBO_COMPARATOR

exercise protocol no supervised

Intervention Type OTHER

Exercise program at the community

Interventions

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controlled, supervised exercise protocol

exercise program within a cardiac rehabilitation program

Intervention Type OTHER

exercise protocol no supervised

Exercise program at the community

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No