Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot

NCT03653104 | Withdrawn

• 1 other identifier: 1802361245
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

COPD; Chronic Obstructive Pulmonary Disease; Dyspnea; Breathlessness; Emphysema; Chronic Bronchitis

Keywords

Melodica; pursed lip breathing; breathing exercise; Music

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Feasibility: Program Participation

  Measured at baseline

• Feasibility: Attendance

  Measured at every intervention session (total of 16 sessions over 8 weeks)

Other Outcomes (3)

• Pilot-Efficacy: Dyspnea Visual Analog Line

  Baseline, before and after each intervention sessions (16 sessionis over 8 weeks).

• Secondary Efficacy: Quality of Life (SF-20)

  Measured at baseline, 4-weeks, 8-weeks

• Secondary Efficacy: Exercise Endurance (6-Minute Walk)

  Measured at baseline, 4-weeks, 8-weeks

Study Arms (4)

Melodica Intervention

EXPERIMENTAL

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

Education Control

ACTIVE COMPARATOR

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

Usual Care Control

NO INTERVENTION

Usual care at Richard L. Roudebush VA Medical Center.

Interview Only

NO INTERVENTION

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

Interventions

Melodica Intervention BEHAVIORAL

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.

Also known as: Melodica Training Program

Melodica Intervention

Pulmonary Health Education BEHAVIORAL

A single session including education about COPD and related health topics.

Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Quality Enhancement Research Intiative: lead

Study Sites (1)

Veteran Health Indiana, Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 33064621 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Dawn M Bravata, MD

  VA Quality Enhancement Research Initiative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine & Adjunct Professor of Neurology

Model Details: This is a safety and feasibility pilot with a single intervention arm, an education control arm, a usual care control arm, and an interview only arm. The intervention arm includes participation in the melodica training program and education about pulmonary health. The education control arm includes pulmonary health education only. The interview only arm includes participation in a semi-structured interview about facilitators and barriers to participation.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 31, 2018
• Study Start: June 12, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 15, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)