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 anticipated during the ongoing pandemic. We have discussed the study with Inova Advanced Lung Disease Clinic contacts who report that self-identified patients have expressed higher levels of worry and concern about infection and family members during the pandemic, thus making them more hesitant to participate in pulmonary rehabilitation or a research study at this time. Our research/exercise lab in the NIH Clinical Center, Rehabilitation Medicine Department continues to be extremely busy with post COVID-19 subjects and studies. At this time, we have not returned to actively pursuing recruitment due to the pandemic and coupled with the hesitancy of the ILD patient population concerning their lung disease and the nature of SARS-CoV2. A reliance agreement was initiated in June, 2021 between the NIH and Inova Fairfax Hospital and remains in place, naming the NIH as the only IRB of record. We plan to continue our collaboration with Inovas Advanced Lung Disease Clinic for direct referrals of patients into the research study once the ILD population is ready. We continue to incorporate a range of strategies to protect our patients and will continue to accept referrals from local pulmonologists once active recruitment resumes. With the increasing numbers of COVID-19 cases during the past two years, and the exercise study intervention for subjects with ILD to include as many as 54 study visits to the NIH during their 14 to 26 weeks of participation, the current public health situation remains challenging for recruitment and retention. At this time, the study remains in the 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