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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00966303
Other study ID # FR150091
Secondary ID
Status Completed
Phase N/A
First received August 25, 2009
Last updated October 5, 2009
Start date June 2008
Est. completion date June 2009

Study information

Verified date October 2009
Source Fortaleza University
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date June 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Fortaleza University - Nucleus of Integrated Medical Attention Fortaleza Ceará

Sponsors (2)

Lead Sponsor Collaborator
Fortaleza University Edson Queiroz Foundation

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks / Twice a week Yes
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