- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00029809
Chinese Exercise Modalities in Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The long-term goal of this project is to study the effects of different exercise modalities on Parkinson's disease (PD). PD is a disorder whose primary disability stems from motor dysfunction including balance. Recent studies have shown that the risk of falling in the elderly can be reduced through the practice of the Chinese complementary and alternative medicine (CAM) such as T'ai Chi Chuan (TCC). This finding may be highly significant to PD. Although a recent report from Emory suggests PD patients can do well with aerobic (walk-run) exercise training (AET), it is still unclear whether the potential anti-Parkinsonian effect of such modalities is secondary to improved physical fitness (CRF), motor control or both. CAM interventions such as TCC may offer a unique opportunity to examine these fundamental questions.
In PD we hypothesize that exercise training will reduce primary and secondary disability and that some of these changes represent adaptive reprogramming of central motor pathways. We will conduct a controlled double-blind, 16-week dose-response study of exercise based on caloric expenditure and thus on the cardiorespiratory fitness effects of exercise (CRF). The treatments will be Qi Gong (minimal caloric expenditure), TCC (low expenditure), and walk-cycle AET (moderate expenditure).
We will examine exercise-induced change in motor control using quantitative measures of motor disability, including dynamic gait stability measures. We will also examine exercise effects on central and peripheral indices of Parkinsonian motor disability.
A caloric "dose-response" effect of exercise would suggest CRF is a major determinant of the anti-Parkinsonian effects of exercise. If the Chinese modalities are as effective or superior to AET however, this would suggest that other mechanisms such as change in central motor programming may be playing a role (e.g. relaxation effects, reinforcement of central motor programs?). A better understanding of exercise-induced neural plasticity and motor control would offer a significant, and heretofore unexploited rehabilitative potential in PD.
Tipo de estudio
Inscripción
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30329
- Emory University School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ambulatory patients with Parkinson's Disease, defined as a clinical state in which at least two of these four cardinal features are present- 1) slowness of movement, 2) tremor at rest, 3) muscular rigidity, 4) gait disturbance or posture imbalance.
- Ambulatory patients with Parkinson's Disease not exercising regularly more than 2x per week. Willing to be randomly assigned to 1 of the 3 exercise modalities: Tai Chi, Qi Gong and Aerobic exercise.
NOTE THAT PARTICIPATION IN THE STUDY REQUIRES BI-WEEKLY PARTICIPATION IN A 16-WEEK SUPERVISED EXERCISE PROGRAM PLUS RELATED EVALUATIONS AT EMORY. ACCORDINGLY, RECRUITMENT IS LIMITED TO LOCAL PATIENTS.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
Colaboradores e Investigadores
Investigadores
- Investigador principal: Jorge L. Juncos, MD, Emory University
Fechas de registro del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01AT000612-01 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre Enfermedad de Parkinson
-
Duke UniversityMedical University of South Carolina; Massachusetts General Hospital; Mayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) y otros colaboradoresAún no reclutandoMicrobiota intestinal | Microbioma intestinal | Enfermedad de Parkinson (EP) | ENFERMEDAD DE PARKINSON (Trastorno) | Enfermedad de Parkinson ProdrómicaEstados Unidos
-
ProgenaBiomeRetiradoEnfermedad de Parkinson | Enfermedad de Parkinson con demencia | Síndrome de Parkinson-Demencia | Enfermedad de Parkinson 2 | Enfermedad de Parkinson 3 | Enfermedad de Parkinson 4Estados Unidos
-
Bezmialem Vakif UniversityReclutamientoEnfermedad de Parkinson | Párkinson | Enfermedad de Parkinson (EP) | ENFERMEDAD DE PARKINSON (Trastorno) | Enfermedad de ParkinsonTurquía (Türkiye)
-
University of Kansas Medical CenterAún no reclutandoEnfermedad de Parkinson (EP)Estados Unidos
-
AbbVieReclutamiento
-
Michael J. Fox Foundation for Parkinson's ResearchReclutamientoEnfermedad de Parkinson ProdrómicaEstados Unidos, Israel, Canadá, Reino Unido, Alemania, Países Bajos
-
EicOsis Human Health Inc.University of California, Davis; Michael J. Fox Foundation for Parkinson's ResearchReclutamientoEnfermedad de Parkinson (EP)Estados Unidos
-
Serina TherapeuticsReclutamientoEnfermedad de Parkinson avanzada | ENFERMEDAD DE PARKINSON (Trastorno)Australia, Estados Unidos
-
University of MinnesotaParkinson's FoundationReclutamientoEnfermedad de Parkinson (EP) | ENFERMEDAD DE PARKINSON (Trastorno)Estados Unidos
-
Bezmialem Vakif UniversityIstanbul University - CerrahpasaAún no reclutandoEnfermedad de Parkinson | ENFERMEDAD DE PARKINSON (Trastorno) | Enfermedad de Parkinson (PD), equilibrio postural