NCT03442140

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

February 8, 2018

Last Update Submit

January 28, 2026

Conditions

COPD

Keywords

COPDShortness of breathHarmonica

Outcome Measures

Primary Outcomes (1)

  • Reduction in Shortness of Breath

    Change 6-minute walk test and spirometry from baseline to 12 weeks and 6 months.

    6 months

Secondary Outcomes (1)

  • saint George Quality of Life

    6 months

Study Arms (1)

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

Interventions

Harmonica playingOTHER

Patients will play the harmonica for up to 6 months

Experimental

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Mark Millard

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 22, 2018

Study Start

August 1, 2017

Primary Completion

March 1, 2018

Study Completion

December 1, 2019

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

US(1)