Clinical trial NCT03653104: Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
Official title: Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Dyspnea
Breathlessness
Emphysema
Chronic Bronchitis
Keywords: Melodica
pursed lip breathing
breathing exercise
Music
Lead sponsor: VA Quality Enhancement Research Intiative
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety: Adverse Events
timeFrame: Measured at baseline and before and after each of 16 program training sessions (8 week duration).
measure: Safety: Dyspnea Visual Analog Line
timeFrame: Baseline, before and after each training session (16 sessions over 8 weeks)
Secondary outcomes:
measure: Feasibility: Program Participation
timeFrame: Measured at baseline
measure: Feasibility: Attendance
timeFrame: Measured at every intervention session (total of 16 sessions over 8 weeks)
Other outcomes:
measure: Pilot-Efficacy: Dyspnea Visual Analog Line
timeFrame: Baseline, before and after each intervention sessions (16 sessionis over 8 weeks).
measure: Secondary Efficacy: Quality of Life (SF-20)
timeFrame: Measured at baseline, 4-weeks, 8-weeks
measure: Secondary Efficacy: Exercise Endurance (6-Minute Walk)
timeFrame: Measured at baseline, 4-weeks, 8-weeks
Locations:
city: Indianapolis
country: United States
facility: Veteran Health Indiana, Richard L. Roudebush VA Medical Center
state: Indiana
Study officials:
affiliation: VA Quality Enhancement Research Initiative
name: Dawn M Bravata, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.