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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00500526
Other study ID # 4626/2004HCFMRP-USP
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received July 11, 2007
Last updated June 27, 2008
Start date January 2005
Est. completion date December 2007

Study information

Verified date June 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of the practice of singing for a long period of time on pulmonary function data, quality of life, and dyspnea sensation of patients with COPD in stable clinical conditions. As singing is a type of respiratory training, the study hypothesis is that singing would improve maximal respiratory pressures, dyspnea sensation, and overall quality of life of these patients.


Description:

Thirty COPD patients in stable clinical conditions are going to be randomized in two groups: the first one is going to have singing classes for six months; the other one is going to have classes of general manual arts for a similar period of time. The patients of both groups are going to perform spirometry, measurements of maximal respiratory pressures and answer the health related quality of life questionnaires SF-36 and Saint George's before the beginning of practice and after 6 months.Both singing and manual arts practices are going to be administered one hour a week by specialized teachers.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis of COPD according GOLD criteria

- Stable clinical conditions for the previous two months

Exclusion Criteria:

- Severe comorbidities other than COPD

- Hypoxemia with partial arterial oxygen pressure lower than 50 mmHg

- Incapacity to come to the research center in a weekly basis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Singing practice

Singing classes

Hand craft classes


Locations

Country Name City State
Brazil Hospital das Clínicas de Ribeirão Preto Ribeirão Preto Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced vital capacity, forced expiratory volume, functional residual capacity, inspiratory capacity, maximal respiratory pressures 6 months
Secondary General quality of life score: SF-36 questionnaire.Specific quality of life score : Saint George's Questionnaire; Basal dyspnea index 6 months
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