The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
8 de noviembre de 2017 actualizado por: Robert Wen-Wei Hsu, Chang Gung Memorial Hospital
Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life.
The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program.
However, it is still unclear regarding the optimal exercise prescription after TKA.
In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment.
The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively.
Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined.
Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups.
Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients.
The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness.
This project will establish the scientific basis for rehabilitation protocol involving knee surgery.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
110
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Chiayi City, Taiwán, 613
- Sports Medicine Center, Chang Gung Memorial Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
65 años a 85 años (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
Exclusion Criteria:
- The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
TKA patients without exercise intervention
|
|
|
Experimental: Exercise
TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )
|
cyclic exercise, aerobic exercise and resistant training exercise
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline bone mineral density
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA).
Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline lower extremity muscle strength
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
Lower extremity muscle strength, including extension and flexion of the hip, knee and ankle were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.
The participants are assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up and received verbal encouragement during the exertion of peak torque.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
|
Motion analysis
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
Gait analysis by VICON three-dimensional, 8-camera motion capture system.The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
|
Change from baseline SF-36 questionnaire assessment
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower score the more disability.
The higher the score the less disability.
Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score.
The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
|
Change from baseline KOOS questionnaire assessment
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life.
Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms).
The User's Guide, is available from www.koos.nu.
The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
|
Physical fitness---6-minutes' walk test
Periodo de tiempo: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
|
The 6-minutes' walk test measures the distance an individual is able to walk over a total of 6 minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in 6 minutes and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month , six month and nine month after operation; twelve-month follow-up
|
|
Physical fitness---2.44 m up and go
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
The 2.44 m up and go test indicates the level of the participant's motor agility and dynamic balance and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
|
Physical fitness---30-sec sit to stand
Periodo de tiempo: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
30-sec sit to stand (times in 30sec) is assessed lower body strength, needed for numerous tasks such as climbing stairs, walking and getting out of a chair.
Also reduces the chance of falling.
Number of full stands that can be completed in 30 seconds with arms folded across chest and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
|
pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2013
Finalización primaria (Actual)
31 de octubre de 2017
Finalización del estudio (Actual)
31 de octubre de 2017
Fechas de registro del estudio
Enviado por primera vez
18 de septiembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
7 de octubre de 2016
Publicado por primera vez (Estimar)
10 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de noviembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
8 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CORPG6C0021-23
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .