Cardiac Rehabilitation in Cardiomyopathies

October 5, 2009 updated by: Fortaleza University

The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy

This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life in patients after cardiac rehabilitation associated with the diaphragmatic muscle training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Fortaleza University - Nucleus of Integrated Medical Attention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Cardiomyopathies in functional class III or IV (New York Heart Association)
  • Aged over 18 years
  • Body mass index below 30 kg/m2

Exclusion Criteria:

  • Confused and depressed patients
  • Cardiac instability and worsening dyspnea after initiation of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cardiac Rehabilitation
9 patients with cardiomyopathy in functional class III or IV, submitted to an 8-week program with exercises and respiratory muscle training.
Other: Cardiac Rehabilitation with diaphragmatic muscle training
Stretching and aerobic exercises and respiratory muscle training with a Threshold ® device, with load of 40% of the maximal inspiratory pressure (MIP), two times a week during one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effectiveness of a cardiac rehabilitation in patients with cardiomyopathy, evaluating the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life.
Time Frame: 8 weeks / Twice a week
8 weeks / Twice a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fortaleza University

Collaborators

Edson Queiroz Foundation

Investigators

  • Principal Investigator: Davi S Sales, Bachelor, Fortaleza University
  • Study Director: Daniela GB Mont'Alverne, Doctor, Fortaleza University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (ESTIMATE)

August 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2009

Last Update Submitted That Met QC Criteria

October 5, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR150091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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