Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
|ClinicalTrials.gov Identifier: NCT01705015|
Recruitment Status : Unknown
Verified September 2012 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : October 12, 2012
Last Update Posted : October 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplantation Liver Transplantation||Behavioral: direct feedback about exercise Behavioral: PLacebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement for Heart or Liver Transplantation Recipients in Early Postoperative Period|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||August 2015|
Experimental: UCFit plus direct feedback about exercise
Subjects assigned to higher feedback will be encouraged to look at the summary of daily data about pedaling and will be encouraged to progress activity - more repetitions per minute (RPM range from 10-60), more frequent sessions (up to 3 times daily), longer sessions (from 5-20 minutes), and exertion against larger forces (no resistance, mild, moderate) for the legs. These subjects will also be encouraged to carry out pedaling with the upper extremities once a day, if the arms are free of lines that could be damaged. Progression of leg exercises would be within the capability and motivation of each subject, but would not exceed increments of 10% from one day to the next in any one of these parameters. Graphical displays that can be used for feedback will be available at the patient's bedside. The staff, patient and family will be able to view these bar graphs.
|Behavioral: direct feedback about exercise|
Placebo Comparator: UCFit plus encouraged exercise
These subjects will receive a graph of the total number of minutes cycled each day and the average RPMs. The coordinator will only encourage these subjects to try to increase their total cycling time. These bar graphs will not be posted, but will be left by the bedside.
UCFit plus encouraged exercise
- 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 [ Time Frame: At discharge of hospital stay, an expected average of 5 weeks, up to 8 weeks after transplantation ]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)
- 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. [ Time Frame: At discharge of hospital stay, an expected average of 5 weeks, up to 8 weeks after transplantation, and 30 days after discharge ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705015
|Contact: SSU-YUAN CHEN, MD, PhD||+886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10002|
|Principal Investigator: SSU-YUAN CHEN, MD, PhD|
|Principal Investigator:||SSU-YUAN CHEN, MD PhD||National Taiwan University Hospital|