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Cardiac Rehabilitation in Cardiomyopathies

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ClinicalTrials.gov Identifier: NCT00966303
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : October 6, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiomyopathies Other: Cardiac Rehabilitation with diaphragmatic muscle training

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy
Study Start Date : June 2008
Primary Completion Date : April 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966303


Locations
Brazil
Fortaleza University - Nucleus of Integrated Medical Attention
Fortaleza, Ceará, Brazil
Sponsors and Collaborators
Fortaleza University
Edson Queiroz Foundation
Investigators
Principal Investigator: Davi S Sales, Bachelor Fortaleza University
Study Director: Daniela GB Mont'Alverne, Doctor Fortaleza University
More Information

Responsible Party: Davi Simões Sales, Fortaleza University
ClinicalTrials.gov Identifier: NCT00966303     History of Changes
Other Study ID Numbers: FR150091
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009

Keywords provided by Fortaleza University:
rehabilitation
dyspnea
strength

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases