Effects of Singing in Chronic Obstructive Pulmonary Disease

June 27, 2008 updated by: University of Sao Paulo

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sao Paulo
      • Ribeirão Preto, Sao Paulo, Brazil, 14048-900
        • Hospital das Clinicas de Ribeirao Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Singing Group
Patients who will receive singing classes
Other: 2 Control group
Patients who will attend hand craft classes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced vital capacity, forced expiratory volume, functional residual capacity, inspiratory capacity, maximal respiratory pressures
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
General quality of life score: SF-36 questionnaire.Specific quality of life score : Saint George's Questionnaire; Basal dyspnea index
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: José B Martinez, MD, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Estimate)

July 2, 2008

Last Update Submitted That Met QC Criteria

June 27, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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