Clinical trial NCT05621967: Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
Official title: Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2022-11-18
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: Randomized control trial. Randomization for each subject occurs twice. First: One of two types of intervention. Second: Sequence for intervention and normal breathing sessions.
Primary purpose: TREATMENT

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.

1. Comparing tonation breathing technique (TBT) to normal breathing:

   1. 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.
   2. 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.
2. Comparing MDVE to normal breathing:

   1. Of the 8 weeks of PR, the first 4 weeks will be sessions of normal breathing exercises for 20 minutes, then the subsequent 4 weeks will be with Music Driven Vocal Exercises (MDVE) intervention for 20 minutes.
   2. Of the 8 weeks of PR, the first 4 weeks will be with MDVE intervention for 20 minutes, then the next 4 weeks will be of sessions of normal breathing exercises for 20 minutes.

These interventions would be performed after the usual PR time when patients would be normally discharged home. Therefore, no additional monitoring is expected.

Pulmonary function testing is standard for all patients who receive PR - testing before and after PR is routine clinical course. The investigators propose an additional pulmonary function test (PFT) study at 4 weeks, as part of the research protocol (covered by the Department of Medicine funding)

In summary, the interventions for research purposes will include:

1. 20-minute sessions after PR for intervention (TBT or MDVE) or normal breathing for twice a week for the 8 weeks they are participating in PR.
2. PFT at end of week 4

Proposed subjective outcomes are routinely asked of PR patients, but will be collected at baseline, at 4 weeks (mid-way), and at 8 weeks (end) of PR. Proposed objective outcomes:

1. For FEV1, FVC - these are routinely collected at baseline and at end of PR. The investigators propose an additional PFT study at 4 weeks, covered by the DOM Faculty Development Fund.
2. For peak flow and NIF - these are procedures that ask for patients to breathe maximally for inspiration and expiration. They are not routine measures collected but are routine bedside measurements for pulmonary patients that can be collected for any person without any additional risk or cost.

Eligibility criteria: 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.

Primary outcomes:
measure: Borg dyspnea score
timeFrame: 8 weeks
Secondary outcomes:
measure: FEV1
timeFrame: 4 and 8 weeks
measure: Borg dyspnea score
timeFrame: 4 weeks
measure: Breath hold
timeFrame: 4 weeks, 8 weeks
measure: quality of life (QOL)
timeFrame: 4 weeks, 8 weeks
measure: forced vital capacity (FVC)
timeFrame: 4 weeks, 8 weeks
measure: peak flow
timeFrame: 4 weeks, 8 weeks
measure: negative inspiratory force (NIF)
timeFrame: 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, MetroHealth Campus
name: Vidya Krishnan, MD, MHS
role: PRINCIPAL_INVESTIGATOR
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