Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot (MELODY)

This project seeks to pilot-test the feasibility of using a melodica training program to teach pursed lip breathing for Veterans with chronic obstructive pulmonary disease (COPD) with moderate to severe dyspnea (shortness of breath). Dyspnea occurs commonly among COPD patients and can limit activities of daily living. Pursed lip breathing is a strategy that can improve dyspnea and exercise capacity among COPD patients. The melodica is a musical instrument that looks like a keyboard with a mouthpiece on the side. The melodica is played by exhaling through the mouthpiece while pressing the keys. The MELODY pilot project protocol has been grounded on concepts from occupational therapy; specifically, providing participants with a meaningful new activity that is enjoyable, that can be provided across a spectrum of skill levels, that can provide participants with a new sense of self, and that can improve health outcomes (i.e., dyspnea and exercise endurance).

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease; Emphysema; COPD; Chronic Bronchitis; Dyspnea; Breathlessness
• Intervention / Treatment: Behavioral: Melodica Intervention; Behavioral: Pulmonary Health Education

Detailed Description

SPECIFIC AIMS:

Primary Aim 1: Evaluate the safety of a melodica training program to teach pursed lip breathing among Veterans with COPD with moderate to severe dyspnea. We hypothesize that a melodica training program can be safely implemented among COPD patients with severe dyspnea.

Primary Aim 2: Evaluate the feasibility of implementing a melodica training program to teach pursed lip breathing among Veterans with COPD with dyspnea. We hypothesize that it will be feasible to implement a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea; specifically that enrolled participants will attend >50% of sessions. We also hypothesize that transportation to the VA Medical Center to attend sessions will be identified as a significant barrier to participation.

Secondary Aim: Collect pilot-efficacy data of a melodica training program to teach pursed lip breathing among Veterans with COPD and dyspnea. The objective is to understand whether melodica training improves dyspnea both in the short-term and in the longer-term over the course of the 8-week training program. We hypothesize that a melodica training program will reduce dyspnea by 30% in the short-term and 10% in the long-term. We also hypothesize that intervention participants will show gains in the secondary efficacy outcome measures of exercise endurance, pulmonary function, entering pulmonary rehabilitation, quality of life, patient global impression of change, and anxiety relative to controls.

RANDOMIZATION AND INTERVENTION:

Randomization:

Participants will be randomized in a 1:1:1 ratio to the intervention group (N=50), usual care control group (N=50), and education control group (N=50) using a block randomization design. We will also seek to identify N=30 Veterans who met the COPD diagnosis and spirometry eligibility criteria but who chose not to participate in the intervention; these Veterans will be invited to participate in a brief interview to identify barriers to participation.

Melodica Program Intervention:

The intervention program will include: education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica playing group which will meet twice-weekly for a 8-week period. Participants will be given instructional materials for use in practicing the instrument in their homes and encouragement to use pursed lip breathing not only while playing the instrument but also in their activities of daily living. Each session will last one hour in duration with approximately 20 minutes for instruction, 30 minutes in group music-making, and 10 minutes allocated for educational information about COPD, tobacco cessation, and pulmonary rehabilitation.

Education Group:

The patients in the education control group will receive the same educational materials that are provided to the intervention group; however, they will receive them in a single educational session. As described above, the educational materials include information about pursed lip breathing, COPD, medications used to treat COPD, how to use an inhaler, smoking cessation, pulmonary rehabilitation, oxygen therapy, exercise, and travelling with COPD. The materials include handouts as well as links to web pages.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Veteran Health Indiana, Richard L. Roudebush VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• spirometry-confirmed COPD defined as a FEV1/FVC <0.7
• moderate or severe dyspnea defined as a grade ≥3 on the ATS Dyspnea scale

Exclusion Criteria:

• visual or hearing impairments
• do not speak English
• do not have an intact airway
• have cognitive impairment
• are unable to make a seal with their mouths
• have a history of at least one hospital admission for congestive heart failure in the prior year
• receiving Hospital-Based Home Care (HBHC) or Telehealth care for COPD management

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melodica Intervention; An 8-week group intervention including twice-weekly sessions. Each session will last one hour in duration with approximately 20 minutes for instruction, 30 minutes in group music-making, and 10 minutes allocated for educational information about COPD, tobacco cessation, and pulmonary rehabilitation.	Behavioral: Melodica Intervention; The melodica program will include education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica training group which meets twice-weekly for an 8-week period. Each session will include musical instruction, group music-making, and education about COPD and related health topics.; Other Names: Melodica Training Program
Active Comparator: Education Control; A single 90-120 minute education session including the same educational information about COPD, tobacco cessation, and pulmonary rehabilitation provided to the melodica intervention group.	Behavioral: Pulmonary Health Education; A single session including education about COPD and related health topics.
No Intervention: Usual Care Control; Usual care at Richard L. Roudebush VA Medical Center.
No Intervention: Interview Only; Semi-structured interviews will be conducted with Veterans who meet eligibility criteria, but who do not agree to participate in the intervention, to identify potential barriers to participation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Adverse Events	We will describe the frequency with which patients reported any adverse events they experienced as a consequence of participation in the program as well as specify the types of adverse events.	Measured at baseline and before and after each of 16 program training sessions (8 week duration).
Safety: Dyspnea Visual Analog Line	We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)	Baseline, before and after each training session (16 sessions over 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Program Participation	Feasibility will be measured in terms of the proportion of eligible Veterans who agree to participate	Measured at baseline
Feasibility: Attendance	Feasibility will be measured in terms of the proportion of sessions that enrolled participants attend	Measured at every intervention session (total of 16 sessions over 8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pilot-Efficacy: Dyspnea Visual Analog Line	We will measure dyspnea with a visual-analog line (100mm line with anchors at 0=no dyspnea, 100=severe dyspnea)	Baseline, before and after each intervention sessions (16 sessionis over 8 weeks).
Secondary Efficacy: Quality of Life (SF-20)	We will assess quality of life based on the 20-item Short Form Health Survey (SF-20)	Measured at baseline, 4-weeks, 8-weeks
Secondary Efficacy: Exercise Endurance (6-Minute Walk)	We will assess exercise endurance measured by the 6-Minute Walk Test (6MWT).	Measured at baseline, 4-weeks, 8-weeks

Collaborators and Investigators

• Sponsor: VA Quality Enhancement Research Intiative
• Investigators: Principal Investigator: Dawn M Bravata, MD, VA Quality Enhancement Research Initiative

Publications and helpful links

General Publications

• McGrath M, Smith J, Rattray NA, Lillie A, Crow S, Myers LJ, Myers J, Perkins AJ, Wasmuth S, Burns DS, Cheatham AJ, Patel H, Bravata DM. Teaching pursed-lip breathing through music: MELodica Orchestra for DYspnea (MELODY) trial rationale and protocol. Arts Health. 2022 Feb;14(1):49-65. doi: 10.1080/17533015.2020.1827277. Epub 2020 Oct 16.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Music; breathing exercise; Melodica; pursed lip breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis; Bronchitis, Chronic; Dyspnea
• Other Study ID Numbers: 1802361245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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