- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04169620
Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial
The aim of this study is to determine the effect of an aquatic Ai Chi training program on the perception of pain, the maintenance of balance and the functional independence of patients with Parkinson's disease.
Fifteen patients diagnosed with Parkinson's disease (Hoehn and Yahr range: 1-3) participated in a program of Aquatic Ai Chi lasting ten weeks with sessions held twice weekly. These were compared to a group of 15 Parkinson patients (control group) who received therapy on dry land.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
All study participants met the following inclusion criteria: individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation). The exclusion criteria were: individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.
The procedure of randomization was performed for the overall sample using stratified randomization controlling for the Hoehn & Yahr stage employing Excell software (Microsoft Excell 2013: Microsoft Corp. Redmond WA).
The participants received an initial assessment on dry land lasting 30-45 minutes, performed by a physiotherapist not involved in the study. Timetable norms were disclosed as well as recommendations regarding appropriate clothing for the activity. A baseline assessment was performed prior to commencing therapy. This was repeated upon completion of all sessions while a follow-up assessment took place one month later.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Almería
-
La CAñada de San Urbano, Almería, España, 04120
- University of Almería
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation).
Exclusion Criteria:
- individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: variable aquatic Ai Chi
The 15 patients assigned to the aquatic therapy group (experimental group) received 20 twice-weekly sessions in total, during the same period of time as the control group. These 20 sessions consisted of group sessions lasting 45-minutes. The sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements. |
The sessions took place in a pool measuring 20 m x 6 m, at a depth of 110 cm. The water temperature was 30oC (with variations of less than 0.5o) and the room temperature was 27.5oC (with variations of less than 1o). The proportions of the pool were ideally suited for collective treatment. The sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements. |
Comparador de placebos: variable dry land
These sessions consisted of group sessions of supervised training lasting 45 minutes each.
These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs.
The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups.
Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching.
|
These sessions consisted of group sessions of supervised training lasting 45 minutes each.
These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs.
The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups.
Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain assessed with VAS scale
Periodo de tiempo: ten weeks
|
VAS scale
|
ten weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Balance assessed with Berg Balance scale
Periodo de tiempo: ten weeks
|
Berg Balance scale
|
ten weeks
|
Functionality assessed with UPDRS scale
Periodo de tiempo: ten weeks
|
UPDRS scale
|
ten weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- spd205
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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
-
ProgenaBiomeReclutamientoEnfermedad de Parkinson | Enfermedad de Parkinson con demencia | Síndrome de Parkinson-Demencia | Enfermedad de Parkinson 2 | Enfermedad de Parkinson 3 | Enfermedad de Parkinson 4Estados Unidos
-
National Heart, Lung, and Blood Institute (NHLBI)TerminadoEnfermedad de Parkinson 6, inicio temprano | Enfermedad de Parkinson (autosómica recesiva, aparición temprana) 7, humana | Enfermedad de Parkinson Autosómica Recesiva, Inicio Temprano | Enfermedad de Parkinson, autosómica recesiva de aparición temprana, digénica, Pink1/Dj1Estados Unidos
-
Assiut UniversityAún no reclutandoMri en Parkinson
-
Medical College of WisconsinRetirado
-
Hacettepe UniversityTerminadoEnfermedad de Parkinson idiopáticaPavo
-
Pôle Saint HélierRennes University Hospital; Réseau Parkinson BretagneTerminadoEnfermedad de Parkinson | Síndrome de ParkinsonFrancia
-
UCB PharmaTerminadoEnfermedad de Parkinson idiopáticaAlemania
-
King's College LondonGlaxoSmithKlineTerminadoEnfermedad de Parkinson | Enfermedad de Parkinson idiopática | Enfermedad de Parkinson, PARK8Reino Unido
-
UCB PharmaTerminadoENFERMEDAD DE PARKINSON IDIOPÁTICAPorcelana
-
AbbVie (prior sponsor, Abbott)Quintiles, Inc.TerminadoEnfermedad de Parkinson avanzadaEstados Unidos, Nueva Zelanda
Ensayos clínicos sobre aquatic Ai Chi
-
Universidade Federal do Rio Grande do NorteDesconocidoEnfermedades de las vías respiratorias | Trastornos de la respiración | Niño | Asma | Hipersensibilidad Respiratoria | Hidroterapia | Enfermedad respiratoriaBrasil
-
Canopy Growth CorporationTerminadoDolor muscular de aparición tardía (DOMS)Estados Unidos
-
National Institute on Aging (NIA)National Center for Complementary and Integrative Health (NCCIH)TerminadoEnvejecimiento | Infección de herpesEstados Unidos
-
Lidian ChenPeking University Third HospitalAún no reclutando
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalTerminado
-
Canopy Growth CorporationJames Madison UniversityTerminado
-
Jonsson Comprehensive Cancer CenterNational Center for Research Resources (NCRR)Activo, no reclutandoDesordenes mentales | Enfermedades del Sistema Nervioso | Disomnias | Trastornos de iniciación y mantenimiento del sueño | Trastornos del sueñoEstados Unidos
-
University of KansasTerminado
-
Sheba Medical CenterTel Aviv UniversityRetiradoCáncer de ovarios | Cáncer peritoneal primario | Otros cánceres ginecológicosIsrael
-
National Center for Complementary and Integrative...TerminadoArtritis ReumatoideEstados Unidos