Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT03653104
Status:
WITHDRAWN
Last Update Posted:
2021-03-15
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
Sponsor:
VA Quality Enhancement Research Intiative
Organization:
Study Overview
Official Title:
Melodica Orchestra for Dyspnea: Safety and Feasibility Pilot
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not initiate study intervention.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MELODY
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: