Back to resultsCardiac Rehabilitation in Cardiomyopathies
Primary Purpose
Cardiomyopathies
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cardiac Rehabilitation with diaphragmatic muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Cardiomyopathies focused on measuring rehabilitation, dyspnea, strength
Eligibility 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
Sites / Locations
- Fortaleza University - Nucleus of Integrated Medical Attention
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac Rehabilitation
Arm Description
9 patients with cardiomyopathy in functional class III or IV, submitted to an 8-week program with exercises and respiratory muscle training.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00966303
First Posted
August 25, 2009
Last Updated
October 5, 2009
Sponsor
Fortaleza University
Collaborators
Edson Queiroz Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00966303
Brief Title
Cardiac Rehabilitation in Cardiomyopathies
Official Title
The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fortaleza University
Collaborators
Edson Queiroz Foundation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies
Keywords
rehabilitation, dyspnea, strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Rehabilitation
Arm Type
Experimental
Arm Description
9 patients with cardiomyopathy in functional class III or IV, submitted to an 8-week program with exercises and respiratory muscle training.
Intervention Type
Other
Intervention Name(s)
Cardiac Rehabilitation with diaphragmatic muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davi S Sales, Bachelor
Organizational Affiliation
Fortaleza University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela GB Mont'Alverne, Doctor
Organizational Affiliation
Fortaleza University
Official's Role
Study Director
Facility Information:
Facility Name
Fortaleza University - Nucleus of Integrated Medical Attention
City
Fortaleza
State/Province
Ceará
Country
Brazil
12. IPD Sharing Statement
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Cardiac Rehabilitation in Cardiomyopathies
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