Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement

Liver Transplantation Clinical Trial

Official title:

Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement for Heart or Liver Transplantation Recipients in Early Postoperative Period

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01705015
• Other study ID #: NSC101-2314-B-002-006-MY3
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2012
• Last updated: October 15, 2012
• Start date: September 2012

Study information

• Verified date: September 2012
• Source: National Taiwan University Hospital
• Contact: SSU-YUAN CHEN, MD, PhD
• Phone: +886-2-23123456
• Email: ssuyuan[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aims of this 3-year randomized, single-blinded clinical trial are to compare the effect of high and low feedback about performance on the bedside exercise device in heart or liver transplantation recipients during the hospitalization immediately after transplantation. The hypotheses of the study are heart/liver transplantation recipients who have high feedback about performance on the bedside exercise device will progressively increase their level of exercise over the course of their hospitalization, more independent in ambulation level, better walking speed and 6-minute walk test at discharge, and better cardiorespiratory fitness at 4-8 weeks after transplantation than those who receive low feedback. The adult patients who newly receive heart or liver transplantation at National Taiwan University Hospital will be evaluated for eligibility of the study in the acute postoperative period. The study will be conducted in both the intensive care unit and ward environments. The study subjects will be randomized to either high or low feedback about performance on the bedside exercise device which uses hand/foot pedals that record exerted forces against adjustable resistances, measure repetitions of upper and lower extremity cycling 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 trial by using triaxial accelerometers, and the activity recognition algorithms developed by engineers and computer scientists at University of California Los Angeles. The outcome measures include level of independence for walking, walking speed, 6-minute walk test, and cardiopulmonary exercise testing by the blinded observers. The study expects to enroll at least 50 heart transplantation recipients and 60 liver transplantation recipients in 3 years. The results of this study will offer much insight into activity levels of heart or liver transplantation recipients during early postoperative period. Besides, heart transplantation recipients will receive routine phase I cardiac rehabilitation program by the physical therapists during the study but not liver transplantation recipients. We might be able to evaluate the interaction effects of routine physical therapy and UCFit exercise among our study subjects. Our data will also provide insight into just how active or inactive transplantation recipients may be and help generate ideas of organ transplantation rehabilitation program to increase their fitness-related activity prior to discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• just received heart or liver transplantation at National Taiwan University Hospital during admission

• over age 18 years old

• living and walking independently, based on the Functional Independence Measure of activities of daily living, within 6 weeks prior to admission

• no major contraindication to participating in light-to-moderate exertion and Per their primary physician in the hospital

• be able to follow and retain 3 minutes later verbal directions to carry out a simple upper and a lower extremity repetitive exercise, such as leg lifts.

Exclusion Criteria:

• unlikely to survive for 3 months

• body mass index >30

• progressive decline in medical status by symptoms or laboratory data (e.g., new onset renal failure or transplant rejection) at the time of entry that is likely to interfere with exercise capacity (subjects may participate once stable);

• skin breakdown that will interfere with positioning for exercise

• inability to lift each leg so that the heel is 6 inches above the bed

• cardiopulmonary contraindication to modest exercise per the care team, such as angina, deep vein thrombosis or hypoxia

• fractures or contractures that prevent use of an extremity for pedaling

• A hemiparesis that is mild enough to permit voluntary placement of the hand and foot onto the apparatus will not be an exclusion, but lesser motor control will.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation
• Liver Transplantation

Intervention

Behavioral:
• direct feedback about exercise

• PLacebo
UCFit plus encouraged exercise

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A.Level of independence for walking 150 feet and the ratio of subjects who achieve independence in walking 150 feet. B. Walking speed for 50 feet. C. 6-minute walk test. D. Findings of cardiopulmonary exercise testing	A.* Level of independence for walking 150 feet (or only for 50 feet if that is feasible) and the ratio of subjects who achieve independence in walking 150 feet in each group based on the criteria of the 7-level scale; B.* Walking speed for 50 feet (or for a subject's lesser feasible distance);C.* 6-minute walk test (including the walking distance in 3 and 6 minutes); D.* Peak oxygen uptake of cardiopulmonary exercise testing (if the exercise testing is not feasible at discharge, findings within 8 weeks after transplantation will be acceptable)	At discharge of hospital stay, an expected average of 5 weeks, up to 8 weeks after transplantation	No
Secondary	A.Total amount of exercise. B.Short Form-36. C. Length of stay in the intensive care unit and hospital. D.Rate of rehospitalization. E.Adverse responses and complications related to exercise.	A.* Total number of daily sessions and total minutes of exercise during the hospital stay; B.* Health-related quality of life by Short Form-36 questionnaire; C.* Length of stay in the intensive care unit and hospital post transplantation; D.* Rate of rehospitalization within 30 days of discharge; E.* Adverse responses and complications related to exercise.	At discharge of hospital stay, an expected average of 5 weeks, up to 8 weeks after transplantation, and 30 days after discharge	Yes