Harmonica Playing Improves Quality of Life in Patients With COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Harmonica playing

• Registration Number: NCT03442140
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Primary Completion: 2018-03-01
• Study Completion: 2019-12-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Harmonica playing	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

Primary Outcome Measures

Name	Time	Method
Reduction in Shortness of Breath	6 months	Change 6-minute walk test and spirometry from baseline to 12 weeks and 6 months.

Secondary Outcome Measures

Name	Time	Method
saint George Quality of Life	6 months	Change in self-reported measures on St. George quality of life questionnaires.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States