Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05621967
Study type Interventional
Source MetroHealth Medical Center
Contact Vidya Krishnan, MD, MHS
Phone 216-778-4527
Email vkrishnan@metrohealth.org
Status Recruiting
Phase N/A
Start date September 7, 2022
Completion date September 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Active, not recruiting NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Active, not recruiting NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Recruiting NCT05542862 - Spikogen Booster Study Phase 3
Recruiting NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Recruiting NCT05200832 - Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
Recruiting NCT05383560 - Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults Phase 2
Enrolling by invitation NCT05089305 - Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection Phase 2
Recruiting NCT04528901 - Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Completed NCT04357990 - Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 N/A
Recruiting NCT05041907 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Phase 2