Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- MetroHealth Medical Center
- Locations
- 2
- Primary Endpoint
- Borg dyspnea score
Study Overview
Brief Summary
To investigate Phonation therapy to improve symptoms and lung physiology in patients referred for pulmonary rehabilitation. The study design will be a randomized controlled trial. The primary outcome is improvement in patient symptoms (Borg dyspnea score). Secondary outcomes are improvement in time of breath hold, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), negative inspiratory force (NIF) and improvement in quality of life. The investigators will be investigating tonation breathing techniques (TBT) exercises and music-driven vocal exercises (MDVE). The study population would be patients who are referred to pulmonary rehabilitation (PR) for symptomatic chronic lung disease. The calculated sample size for the study would be 16 patients and the duration of the study would be 8 weeks. The study would be performed after the participant's pulmonary rehabilitation session.
Detailed Description
Patients who are referred for pulmonary rehabilitation for chronic lung disease and/or post-COVID19 therapy, and who have had pulmonary function testing already will be approached. Pulmonary rehabilitation is an 8-week program (meeting 3 times per week for the 8 weeks). Pulmonary rehabilitation (PR) is the standard of care for patients with chronic lung diseases and or post-COVID-19 therapy. Eligible study participants will be called prior to their introductory PR session to explain the research project, and those who are interested will be given full information and offered time to ask questions. The investigators find this necessary for logistics, given many of the PR patients rely on scheduled transportation to/from PR and this will allow those who are interested in obtaining more information and to consent to the study to arrange for appropriate transportation. Informed consent will be done in person on an individual basis at their introductory PR session, with 1:1 discussion with the study staff and the patient.
As this is a pilot study to determine feasibility, and preliminary data (as no data are currently available for this patient population), the investigators propose 16 participants in total, 4 in each arm of the study. Randomization will occur by random number generator (1-4 for each arm proposed).
Once informed consent is obtained, patients will be randomized to 4 arms of the study. Randomization will be performed using a random number generator.
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Comparing tonation breathing technique (TBT) to normal breathing:
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Of the 8 weeks of PR, first 4 weeks will be sessions of normal breathing exercises for 20 minutes, then subsequent 4 weeks will be with TBT intervention for 20 minutes.
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Of the 8 weeks of PR, the first 4 weeks will be with TBT intervention for 20 minutes, then the next 4 weeks will be of sessions of normal breathing exercises for 20 minutes.
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Comparing MDVE to normal breathing:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and older
- •English-speaking and reading patient
- •Able to consent for study
- •Referred for pulmonary rehabilitation for chronic lung disease (including long COVID19 syndrome, COPD, ILD, PH)
- •Baseline Borg dyspnea score as moderate (score 3) or higher.
- •Has baseline pulmonary function testing available in electronic medical record.
Exclusion Criteria
- •Cannot commit to staying an extra 30 min after Pulmonary Rehabilitation sessions for the study.
Outcomes
Primary Outcomes
Borg dyspnea score
Time Frame: 8 weeks
subjective score of dyspnea
Secondary Outcomes
- FEV1(4 and 8 weeks)
- quality of life (QOL)(4 weeks, 8 weeks)
- peak flow(4 weeks, 8 weeks)
- negative inspiratory force (NIF)(4 weeks, 8 weeks)
- forced vital capacity (FVC)(4 weeks, 8 weeks)
- Borg dyspnea score(4 weeks)
- Breath hold(4 weeks, 8 weeks)
Investigators
Vidya Krishnan
Professor of Medicine: Pulmonary, Critical Care and Sleep Medicine
MetroHealth Medical Center