Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients with Interstitial Lung Disease

Clinical Center

Investigators

Abstract

AET is generally safe, inexpensive, and can easily be made available and accessible to almost everyone. It requires no approval by regulatory agencies and is thus available as a medically prescribed and supervised intervention almost immediately following confirmation of its safety and efficacy. Six-minute walk distance is associated with improved HRQoL in patients with ILD and in specific subsets. Effective use of AET as a rehabilitative intervention could have a high degree of impact on personal and public health outcomes in this advanced lung disease subset. Total Number of Subjects Screened= 175 (over the life of the protocol) Total Number of Subjects Enrolled = 46 Total Number of Subjects Enrolled in the current year =0 Total Number of Subjects Enrolled that dropped this year =0 Number consented (including screen failures and withdrawals/dropouts):46 over the life of the protocol = 46 since last CR = 0 All of the enrolled study subjects have completed the 1 year follow up phase of the protocol. The study is still in collection phase and there have been no findings thus far from this research. The total accrual reported during the last CR remain the same this year due to the pandemic. To date we have pre-screened over 175 patients, demonstrating the interest of this study for patients and referring physicians. However, the comprehensive list of inclusion/exclusion for co-morbidities and stabilization of treatments, as well as developing conditions as a result of the disease process is among the primary reasons interested patients do not for qualify for this study. Our ability to meet our target enrollment by the end of this year or next is not expected given the COVID-19 health crisis. We will be meeting with Inova Hospital to discuss the way forward. Our research/exercise lab at the NIH and Inovas pulmonary rehabilitation department have been extremely busy with post COVID-19 subjects and studies. We have not returned to actively pursuing recruitment during the pandemic as the ILD patient population tends to be limited due to their lung disease and the nature of SARS-CoV2. A reliance agreement was recently put in place in June 2021 between the NIH and Inova Fairfax Hospital, naming the NIH as the only IRB of record. We will continue the collaboration with Inova Fairfax Advanced Lung Disease Clinic for direct referrals of patients recommended for pulmonary rehabilitation, as well as the occasional referrals from other pulmonologists in the area. During this past CR year, Dr. Randall Keyser retired from his position at George Mason University so we are no longer affiliated with George Mason University. Dr. Keyser will likely return as a special volunteer or in some capacity, yet to be determined. Of note, in this exercise study intervention, subjects with ILD may make as many as 54 study visits to the NIH during their 14 to 26 weeks of participation, making the current public health emergency extra challenging for recruitment and retention. The study remains in collection phase and there have been no findings thus far from this research. Publications generated by this year's research: No publications are associated with this Annual Report Publications generated by this year's research: No publications are associated with this Annual Report