Vendetti Melissa L, Esther Moon Seol Ju, Imes Christopher C, Hergenroeder Andrea, Sciurba Frank, Lendermon Elizabeth, Pilewski Joseph, Ren Dianxu, Parmanto Bambang, Dewhirst Barbara, Willey Bryan, Jones Kristen, Morrell Matthew R, Sanchez Pablo, DeVito Dabbs Annette
University of Pittsburgh, School of Nursing, Department of Acute and Tertiary Care, Pittsburgh, PA, USA.
University of Pittsburgh, School of Health and Rehabilitation Sciences, Department of Physical Therapy, Pittsburgh, PA, USA.
Contemp Clin Trials Commun. 2023 Feb 28;33:101097. doi: 10.1016/j.conctc.2023.101097. eCollection 2023 Jun.
Lung transplantation is an established treatment option for persons with advanced lung disease. After transplantation, lung function typically returns to near normal levels, however exercise capacity remains low due to chronic deconditioning, limited physical function, and inactive lifestyles which undermine the intended benefits of the highly selective, resource-intensive transplant procedure. Pulmonary rehabilitation is recommended to improve fitness and activity tolerance, however due to multiple barriers, lung transplant recipients either never participate, or fail to complete, pulmonary rehabilitation programs.
To describe the design of Lung Transplant Go (LTGO), a trial modified for the remote environment based on recommendations to preserve trial integrity during COVID. The aims are to evaluate a behavioral exercise intervention to improve physical function, physical activity, and blood pressure control in lung transplant recipients conducted safely and effectively using a telerehabilitation (telerehab) platform, and to explore the role of potential mediators and moderators of the relationship between LTGO and outcomes.
Single-site, 2-group randomized controlled trial with lung transplant recipients randomized 1:1 to either the LTGO intervention (a 2-phased, supervised, telerehab behavioral exercise program), or to enhanced usual care (activity tracking and monthly newsletters). All study activities, including intervention delivery, recruitment, consenting, assessment, and data collection, will be performed remotely.
If efficacious, this fully scalable and replicable telerehab intervention could be efficiently translated to reach large numbers of lung recipients to improve and sustain self-management of exercise habits by overcoming barriers to participation in existing, in-person pulmonary rehabilitation programs.
肺移植是晚期肺部疾病患者既定的治疗选择。移植后,肺功能通常会恢复到接近正常水平,然而,由于慢性失健、身体功能受限以及久坐不动的生活方式,削弱了这种高选择性、资源密集型移植手术的预期益处,运动能力仍然较低。建议进行肺康复以提高体能和活动耐量,然而,由于多种障碍,肺移植受者要么从未参加过肺康复计划,要么未能完成该计划。
描述“肺移植行动(LTGO)”试验的设计,该试验是根据在新冠疫情期间保持试验完整性的建议而针对远程环境进行调整的。目的是评估一种行为运动干预措施,以改善肺移植受者的身体功能、身体活动和血压控制,该干预措施使用远程康复(远程康复治疗)平台安全有效地进行,并探讨LTGO与结果之间关系的潜在中介因素和调节因素的作用。
单中心、两组随机对照试验,肺移植受者按1:1随机分为LTGO干预组(一个分两阶段、有监督的远程康复行为运动计划)或强化常规护理组(活动跟踪和月度时事通讯)。所有研究活动,包括干预实施、招募、同意参与、评估和数据收集,都将远程进行。
如果有效,这种完全可扩展且可复制的远程康复治疗干预措施可以有效地推广应用,以惠及大量肺移植受者,通过克服参与现有面对面肺康复计划的障碍,改善并维持运动习惯的自我管理。