Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
15 de outubro de 2012 atualizado por: National Taiwan University Hospital
Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement for Heart or Liver Transplantation Recipients in Early Postoperative Period
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.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
110
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Taipei, Taiwan, 10002
- Recrutamento
- National Taiwan University Hospital
-
Investigador principal:
- SSU-YUAN CHEN, MD, PhD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
|
Comparador de Placebo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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
Prazo: 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)
|
At discharge of hospital stay, an expected average of 5 weeks, up to 8 weeks after transplantation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: 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.
|
At discharge of hospital stay, an expected average of 5 weeks, up to 8 weeks after transplantation, and 30 days after discharge
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: SSU-YUAN CHEN, MD PhD, National Taiwan University Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2012
Conclusão Primária (Antecipado)
1 de agosto de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
11 de setembro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de outubro de 2012
Primeira postagem (Estimativa)
12 de outubro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de outubro de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de outubro de 2012
Última verificação
1 de setembro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- NSC101-2314-B-002-006-MY3
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Transplante de Fígado
-
Fondazione Policlinico Universitario Agostino Gemelli...Ainda não está recrutandoCirrose hepática | Hipertensão Portal Não Cirrótica | Hipertensão portal relacionada à cirrose | Elastografia Ultrassônica | Ultrassom com contraste | Porto-sinusoidal Vascular Liver DisorderItália