2016-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646730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，在每日使用床邊運動器材25 分鐘以上時，對其獨立行走能力、行走速度、六分鐘行走測試距離、健康相關生活品質、心率變異性、心肺耐力以及膝伸肌肌力之作用。本研究之假說為：術後初期的心臟或肝臟移植病患，在每日使用床邊運動器材25 分鐘以上時(「運動訓練組」)，與僅獲得一般性的術後照護(「一般照護組」)受試者相較，其將會在術後住院期間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、擁有較佳的健康相關生活品質、心率變異性、心肺耐力以及膝伸肌肌力。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。本研究團隊目前進行中之3 年期研究計畫為第一個利用床邊運動器材針對剛接受心臟或肝臟移植的成年病患在住院期間(包括加護病房及普通病房)的介入性復健訓練臨床試驗，我們初步的資料分析顯示，心臟或肝臟移植病患術後初期可以安全並有效的使用床邊運動器材從事復健運動訓練，然而「活動增強回饋」並無法有效的增進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。我們若將所有受試者重新分組，每日使用床邊運動器材25 分鐘以上的24 位受試者其行走速度、6 分鐘行走測試的距離、健康生活品質以及最大運動心肺功能顯著優於另外每日使用床邊運動器材少於25 分鐘的27 位受試者。因此，每日使用床邊運動器材25 分鐘以上對心臟或肝臟移植病患術後之復健作用，值得並需要進一步的研究。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在住院期間(包括加護病房及普通病房)加入本研究，並以隨機分派方式分成「運動訓練組」及「一般照護組」。「運動訓練組」除了提供可透過智慧型手機將患者實際從事之運動量及資料上傳的床邊運動器材，並將鼓勵其達到每日25 分鐘以上的預設目標，這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。主要預後變項為出院時的獨立行走能力、行走速度、六分鐘行走測試距離、健康相關生活品質、心率變異性、心肺耐力以及膝伸肌肌力之結果。預期成果：本三年期的研究計畫預計完成30 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活動量資訊回饋)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, assessor-blinded clinical trial are to investigate the effectof exercise 25 min or more per day on the bedside exercise device in heart or livertransplantation recipients who are at-risk for functional deterioration during a long inpatientstay after transplantations. The hypotheses of the study are heart/liver transplantationrecipients who perform the UCFit exercise 25 min or more per day will be more independentin ambulation level, better walking speed, 6-minute walk test, heart rate variability, andhealth-related quality of life at discharge, and better cardiorespiratory and muscular fitnessat 1-2 months after transplantation than those in control group.Background:Heart or liver transplantation is widely regarded as a viable alternative for individuals withend-stage heart or liver disease nowadays. Rehabilitation for patients who have had heart orliver transplants 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. In preliminary analysis of our ongoing study, the first trial of bedsideexercise device with remote monitoring for inpatient organ transplantation rehabilitation,augmented feedback alone did not improve outcomes of interest. Exercise training usingbedside exercise device is feasible and safe in heart or liver transplantation recipients in theearly postoperative period. In secondary data analysis, patients using bedside exercise devicefor 25 minutes or more per day (n=24) had significantly better independence for walking,walking speed, 6-min walk distance, health-related quality of life scores in physicalfunctioning and vitality, and cardiorespiratory fitness during cardiopulmonary exercise testcompared with patients using bedside exercise device for less than 25 minutes per day (n=27).The effect of using bedside exercise device for 25 minutes or more per day during inpatientorgan transplantation rehabilitation warrants further investigation.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 UCFit exercise group or usualcare group. Patients assigned to UCFit exercise group will exercise on the bedside exercisedevice which uses hand/foot pedals that record exerted forces against adjustable resistances,measure repetitions of upper and lower extremity cycling movements, and give feedbackabout performance via a wireless internet connection. The outcome measures include Levelof independence for walking, walking speed, 6-minute walk test, health-related quality of life,heart rate variability, cardiopulmonary exercise testing and isokinetic strength of kneeextensors by the blinded observers.Expected achievement: The study expects to enroll at least 30 heart transplantationrecipients and 60 liver transplantation recipients in 3 years. The results of this study willconfirm the utility of the inexpensive, small, lightweight bedside device with remotemonitoring on organ transplantation rehabilitation. Besides, heart transplantation recipientswill receive routine phase I cardiac rehabilitation program by the physical therapists but notliver transplantation recipients. We might be able to evaluate the interaction effects ofroutine physical therapy and UCFit exercise among our study subjects. Our data will alsoprovide insight into just how active or inactive patients may be and help generate ideas toincrease their fitness-related activity prior to discharge.心臟移植肝臟移植最大運動心肺功能檢查運動訓練床邊運動器材復 健heart transplantationliver transplantationcardiopulmonary exercise testingexercise trainingbedside exercise devicerehabilitation