2014-08-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/657014摘要：研究目的：本研究為三年期單盲隨機對照試驗，其目的是想探討術後初期的心臟或肝臟移植病患，在使用床邊運動器材並獲得不同程度的活動增強回饋(activity reinforcement)時，對其獨立行走能力、行走速度、以及心肺耐力之作用。本研究之假說為：術後初期的心臟或肝臟移植病患，在使用床邊運動器材並獲得較多的活動增強回饋時(「活動增強回饋組」)，與僅獲得一般性的活動增強回饋(「一般運動組」)受試者相較，其將會在術後住院期間比較積極的增加其活動量、恢復獨立行走能力的時間較短、出院時的行走速度較快、6 分鐘行走測試的距離較遠、以及擁有較佳的運動心肺功能。背景：當以保守治療方式治療心臟衰竭或肝臟衰竭患者而效果不彰時，心臟或肝臟移植手術是合理且重要的治療方式。心臟或肝臟移植病患術後皆會在加護病房及普通病房住院一段期間後，方能出院。由於病患手術前的嚴重病況以及術後的傷口及多種管路，這些患者往往經歷了長期臥床；而長期臥床會造成患者姿勢性低血壓、心跳變快、心肺功能衰退、肌肉萎縮、關節僵硬、影響其站立及行走之功能。心臟或肝臟移植病患術後住院期間接受運動訓練或復健，應可協助加速其恢復日常活動功能及改善心肺耐力，然而目前僅心臟移植病患會常規性的接受術後復健治療。此外，文獻回顧也發現僅有少數的研究探討心臟或肝臟移植病患術後初期接受運動訓練或復健之成效。研究方法：本研究將邀請在臺大醫院剛接受心臟或肝臟移植的成年病患加入本研究，除了在住院期間(包括加護病房及普通病房)提供其床邊運動器材，並以隨機分派方式分成「活動增強回饋組」及「一般運動組」。本研究之床邊運動器材可透過智慧型手機將患者實際從事之運動量及資料上傳，且受試者須於兩下肢踝部佩戴三向式活動測量計以記錄其活動型式、活動量與活動品質，這兩種活動量監測之技術主要是由加州大學洛杉磯分校的研究團隊協助支援。「活動增強回饋組」患者將可獲得較多的活動增強回饋資訊。主要預後變項為出院時的獨立行走能力、行走速度、6 分鐘行走測試的距離、以及最大運動心肺功能測驗之結果。預期成果：本三年期的研究計畫預計完成50 位心臟移植患者以及60 位肝臟移植患者的收案、隨機分派、運動介入(提供床邊運動器材及不同程度的活動增強回饋)與結果分析。本研究成果將可了解心臟或肝臟移植患者在術後初期的住院期間，其行走能力進步時程及運動參與情況。由於僅心臟移植患者會在住院期間內常規性的接受術後復健治療，本研究也可分析「住院期復健治療」與「提供其床邊運動器材」兩種運動介入方式的交互作用。本研究成果，也可對器官移植術後住院期間的復健計畫及患者運動處方設計提供重要之參考。<br> Abstract: Purpose of study:The aims of this 3-year randomized, single-blinded clinical trial are to compare the effect ofhigh and low feedback about performance on the bedside exercise device in heart or livertransplantation recipients during the hospitalization immediately after transplantation. Thehypotheses of the study are heart/liver transplantation recipients who have high feedbackabout performance on the bedside exercise device will progressively increase their level ofexercise over the course of their hospitalization, more independent in ambulation level,better walking speed and 6-minute walk test at discharge, and better cardiorespiratoryfitness at 4-8 weeks after transplantation than those who receive low feedback.Background:Heart or liver transplantation is widely regarded as a viable alternative for individuals withend-stage heart or liver disease nowadays. These transplantation recipients are admitted tointensive care units in the acute postoperative period. The immobility may lead to increasedpostural hypotension and tachycardia, putting patients at risk for syncope, falls, and aninability to stand or exercise. Rehabilitation for patients who have had heart or livertransplants is often necessary to restore functional mobility in the acute postoperativeperiod. Currently, only heart transplantation recipients receive routine phase I cardiacrehabilitation program by the physical therapists in Taiwan. The problem is how toaccomplish exercise in patients who encounter great difficulty moving without help andwhile tethered to intravenous lines and monitors. Scarce small sample studies havedemonstrated the exercise benefits of heart or liver transplantation recipients in the earlypostoperative period.Study protocol: The adult patients who newly receive heart or liver transplantation atNational Taiwan University Hospital will be evaluated for eligibility of the study in the acutepostoperative period. The study will be conducted in both the intensive care unit and wardenvironments. The study subjects will be randomized to either high or low feedback aboutperformance on the bedside exercise device which uses hand/foot pedals that record exertedforces against adjustable resistances, measure repetitions of upper and lower extremitycycling movements, and give feedback about performance via a wireless internet connection.The study will also monitor the amount of daily movement activity of all subjects in this trialby using triaxial accelerometers, and the activity recognition algorithms developed byengineers and computer scientists at University of California Los Angeles. The outcomemeasures include Level of independence for walking, walking speed, 6-minute walk test, andcardiopulmonary exercise testing by the blinded observers.Expected achievement: The study expects to enroll at least 50 heart transplantationrecipients and 60 liver transplantation recipients in 3 years. The results of this study will offermuch insight into activity levels of heart or liver transplantation recipients during earlypostoperative period. Besides, heart transplantation recipients will receive routine phase Icardiac rehabilitation program by the physical therapists during the study but not livertransplantation recipients. We might be able to evaluate the interaction effects of routinephysical therapy and UCFit exercise among our study subjects. Our data will also provideinsight into just how active or inactive transplantation recipients may be and help generateideas of organ transplantation rehabilitation program to increase their fitness-related activityprior to discharge.心臟移植肝臟移植最大運動心肺功能檢查運動訓練復健heart transplantationliver transplantationcardiopulmonary exercise testingexercise trainingrehabilitation