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Effects of Singing in Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Singing practice

Singing classes

Hand craft classes

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pulmonary function, Respiratory muscle, Dyspnea, Quality of life

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital das Clínicas de Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1 Singing Group

2 Control group

Arm Description

Patients who will receive singing classes

Patients who will attend hand craft classes

Outcomes

Primary Outcome Measures

Forced vital capacity, forced expiratory volume, functional residual capacity, inspiratory capacity, maximal respiratory pressures

Secondary Outcome Measures

General quality of life score: SF-36 questionnaire.Specific quality of life score : Saint George's Questionnaire; Basal dyspnea index

Full Information

NCT ID

NCT00500526

First Posted

July 11, 2007

Last Updated

June 27, 2008

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00500526

Brief Title

Effects of Singing in Chronic Obstructive Pulmonary Disease

Official Title

Effects of Singing on Dyspnea, Quality of Life and Pulmonary Function Parameters of COPD Patients in Stable Conditions.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Pulmonary function, Respiratory muscle, Dyspnea, Quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Singing Group

Arm Type

Experimental

Arm Description

Patients who will receive singing classes

Arm Title

2 Control group

Arm Type

Other

Arm Description

Patients who will attend hand craft classes

Intervention Type

Other

Intervention Name(s)

Singing practice

Intervention Type

Other

Intervention Name(s)

Singing classes

Intervention Type

Other

Intervention Name(s)

Hand craft classes

Primary Outcome Measure Information:

Title

Forced vital capacity, forced expiratory volume, functional residual capacity, inspiratory capacity, maximal respiratory pressures

Time Frame

6 months

Secondary Outcome Measure Information:

Title

General quality of life score: SF-36 questionnaire.Specific quality of life score : Saint George's Questionnaire; Basal dyspnea index

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José B Martinez, MD, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clínicas de Ribeirão Preto

City

Ribeirão Preto

State/Province

Sao Paulo

ZIP/Postal Code

14048-900

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19436683

Citation

Bonilha AG, Onofre F, Vieira ML, Prado MY, Martinez JA. Effects of singing classes on pulmonary function and quality of life of COPD patients. Int J Chron Obstruct Pulmon Dis. 2009;4:1-8. Epub 2009 Apr 15.

Results Reference

derived

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Effects of Singing in Chronic Obstructive Pulmonary Disease

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