Cardiac Rehabilitation in Cardiomyopathies

This study has been completed.
Sponsor:
Collaborator:
Edson Queiroz Foundation
Information provided by:
Fortaleza University
ClinicalTrials.gov Identifier:
NCT00966303
First received: August 25, 2009
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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 Intervention
Cardiomyopathies
Other: Cardiac Rehabilitation with diaphragmatic muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Fortaleza University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Davi Simões Sales, Fortaleza University
ClinicalTrials.gov Identifier: NCT00966303     History of Changes
Other Study ID Numbers: FR150091
Study First Received: August 25, 2009
Last Updated: October 5, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Fortaleza University:
rehabilitation
dyspnea
strength

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014