Harmonica Playing Improves Quality of Life in Patients With COPD

Harmonica Playing Improves Inspiratory and Expiratory Muscle Strength, Reduces Shortness of Breath With Activity, and Improves Quality of Life in Patients With COPD

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Harmonica playing

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Shortness of Breath	Change 6-minute walk test and spirometry from baseline to 12 weeks and 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
saint George Quality of Life	Change in self-reported measures on St. George quality of life questionnaires.	6 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COPD; Shortness of breath; Harmonica
• Other Study ID Numbers: 017-135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No