NCT00500526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

Enrollment Period

2.9 years

First QC Date

July 11, 2007

Last Update Submit

June 27, 2008

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDPulmonary functionRespiratory muscleDyspneaQuality of life

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

1 Singing Group

EXPERIMENTAL

Patients who will receive singing classes

Other: Singing practiceOther: Singing classes

2 Control group

OTHER

Patients who will attend hand craft classes

Other: Hand craft classes

Interventions

Singing practiceOTHER
1 Singing Group
Singing classesOTHER
1 Singing Group
Hand craft classesOTHER
2 Control group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD according GOLD criteria
  • Stable clinical conditions for the previous two months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 19436683DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • José B Martinez, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

BR(1)