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Harmonica Playing Improves Quality of Life in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442140
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
15 patients who have completed the Baylor Martha Foster Lung Center Pulmonary Rehabilitation Program at least six months ago will be selected to participate in a 12 week training program with six months of follow up.

Condition or disease Intervention/treatment Phase
COPD Other: Harmonica playing Not Applicable

Detailed Description:

Subjects will be consented and evaluated prior to beginning the Harmonica Training. Subjects will undergo spirometry testing, six minute walk testing and inspiratory capacity, inspiratory and expiratory respiratory muscle strength will be measured. A music therapist will evaluate their ability to assess the participant's ability to play the harmonica and offer assistance during the training. Subjects will complete a self-reported depression, shortness of breath, and quality of life questionnaire. All evaluations and questionnaires will be completed before and after the 12 week program and six months after the training program.

They will be trained to play the Harmonica and practice as a group during a twelve week program, for one hour a day, one day a week with the Instructors, one is a Registered Respiratory Therapist and the other is a music therapist, who will evaluate their ability and offer assistance. The music therapist will meet individually with each study participant at the beginning of the study to assess participants' harmonica playing ability.

They are required to practice at home (individually) in between classes for 30 minutes five days a week outside the formal training hour with the group. They may use oxygen as prescribed by their physician during the training. The training booklet includes information to help the subject with COPD understand how this program is designed to help them. They will also be given instructions on how to clean the harmonica and infection control measures to use during the program to prevent infections that could occur using the harmonica.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Harmonica Playing Improves Inspiratory and Expiratory Muscle Strength, Reduces Shortness of Breath With Activity, and Improves Quality of Life in Patients With COPD
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Patients who completed the Baylor Martha Foster Lung Center Pulmonary Rehabilitation Program at least six months ago will participate in the 12-week harmonica program
Other: Harmonica playing
Patients will play the harmonica for up to 6 months




Primary Outcome Measures :
  1. Reduction in Shortness of Breath [ Time Frame: 6 months ]
    Change 6-minute walk test and spirometry from baseline to 12 weeks and 6 months.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]
    Change in self-reported measures on quality of life questionnaires.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness to attend 12 weeks of harmonica training for one hour a day per week
  • Practice playing at home 30 minutes x 5 days a week
  • Documented diagnosis of COPD
  • Ability to perform spirometry, IC, MIP, and MEP maneuver and 6 minute walk
  • Willing to complete depression, quality of life, shortness of breath, functional evaluation questionnaires
  • Willing to perform in a group setting

Exclusion Criteria:

  • Current COPD exacerbation
  • Inability to perform spirometry, IC, MIP and MEP maneuver
  • Inability to commit to weekly one hour sessions for 12 weeks and practice for 5 days/week.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442140


Locations
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United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03442140     History of Changes
Other Study ID Numbers: 017-135
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baylor Research Institute:
COPD
Shortness of breath
Harmonica

Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms