Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The Effect of Resistance Training in Parkinson Disease: A Pilot Study

17 de abril de 2019 actualizado por: University of Sao Paulo General Hospital

The Effect of Resistance Training on Balance in Patients With Parkinson Disease: A Pilot Study

To investigate if resistance training exercises performed twice a week with or without gym equipment assistance in a 12-week period could improve balance in patients with Parkinson Disease (PD).

Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and preserved cognitive function will participate in this study. Patients will be randomized among three intervention groups: resistance training with free weights, resistance training with gym equipment and control group. Investigators will use static platform balance variables to assess the primary end-point outcome measures. For the secondary outcomes measures, most common clinical functional balances tests for PD will be applied: Berg Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and variables from dynamic posturography.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Parkinson's disease is a progressive neurodegenerative disease that affects motor functions and is characterized by bradykinesia, resting tremor, rigidity, and postural instability. Despite of pharmacological treatments, patients remain with deficits in balance, gait, autonomic system functions and cognition which impact on their quality of life.

The effects of resistance training on PD are still controversial when balance and improvement on functional tests are the targets.

Since the results of previous studies about resistance training on balance are still controversial, more interventions are required to address the question if strengthening exercise may improve or not the balance of PD patients. Our exercises will target the trunk, leg and shoulder muscles because of their contribution on patient's posture.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

63

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

  • Brasil
      • Sao Paulo, Brasil, 05403010
        • Department of Neurology of University of Sao Paulo

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

50 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age between 50 to 75 years old;
  • Hoehn and Yahr stages II or III;
  • Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
  • Ability to walk independently without walking devices aid;
  • Absence of orthopedic injuries or pain in joints that could interfere on training program;
  • Stable medication regimen for PD treatment at recruitment stage;
  • Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
  • No cardiovascular instability;
  • No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
  • Availability to come to the clinic twice a week;
  • Not participating in other physical rehabilitation programs during and six months prior to the study.

Exclusion Criteria:

  • Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Gym Group
With gym equipments, twice per week for 12 weeks.
Otro: Gym Group

Patients from Gym Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period.

The initial load is established as 60% of one-repetition maximum strength test (1RM) applied for each exercise at the beginning of program. Patients will be encouraged to perform 3 sets of 8 to 12 repetitions. All subjects will be instructed to rest for 30-60 second intervals between sets.
Comparador activo: Free Weights Group
With dumbbells, elastics, twice per week for 12 weeks.
Otro: Free Weights Group
Patients from Free Weights Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The program aim to recruit the same muscles requested in Gym Group. Investigators will apply six different exercises with patients lying supine,standing in stance, sitting and in four points kneeling. All exercises aim to strengthen abdominal muscles, trunk extensors, gluteus, quadriceps and scapula adductors. Patients will perform 3 sets of 8 to 12 repetitions, the load will be offered with dumbbells, elastics with different resistances and anklets.
Comparador de placebos: Control Group
The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.
Otro: Control Group
All three groups will be instructed to perform stretching exercises of trunk, leg and shoulder muscles, according to an illustrated booklet. Only the Control Group patients will be instructed to perform stretching exercises at home in the same 12-week period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postural sway on Static Posturography
Periodo de tiempo: 12 weeks
Static Posturography is a technique used to objectively assess postural sway with patients standing still on a fixed platform that measures center of pressure displacement. Tests were standardized such as the feet position, the eye gaze and environment light, with three trials of 60-second test in eyes - open, eyes closed and eyes open in dual task condition. Investigators will analyze the anteroposterior displacement, medial-lateral displacement, area, velocity and path length.
12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Balance on Berg Balance Scale
Periodo de tiempo: 12 weeks
Berg Balance Scale is used to assess balance and falls in elderly using different tasks. It consists of 14 tasks scoring from zero to four, zero means that the patient is unable to perform the task and four means that the task is performed independently.
12 weeks
Balance Evaluation on Mini-BESTest
Periodo de tiempo: 12 weeks
The Mini-BESTest contains 14 items that assess dynamic balance focusing on anticipatory postural adjustments, postural responses, sensory orientation and stability in gait. Items are scored from 0 to 2 (normal performance in balance).
12 weeks
Functional balance and gait on Timed Up and Go test (TUG)
Periodo de tiempo: 12 weeks
The TUG test measures individual speed while performing the sequence: rising from a chair, walking for three meters of distance, turning around and returning to the starting position, sitting on a chair. When the examination exceeds 13 seconds, patients have higher risk of falls.
12 weeks
Quality of life on PDQ-39 Questionnaire
Periodo de tiempo: 12 weeks
The PDQ-39 assess quality of life of Parkinson's disease patients over the last month. Contains 39 items and eight dimensions (Mobility, Activities of daily living, Emotional well-being, Stigma, Social support, Cognitions and Bodily discomfort).
12 weeks
Functional balance on Dynamic Posturography
Periodo de tiempo: 12 weeks
Dynamic posturography is a quantitative method to assess balance. This system have sensors located below two platforms and measures vertical and horizontal forces produced by the center of gravity during a pre-determined task (sit to stand, tandem walk and step over).
12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Sao Paulo General Hospital

Investigadores

  • Director de estudio: Egberto Reis Barbosa, MD, PhD, Department of Neurology, Clinics Hospital of University of São Paulo Faculty of Medicine, São Paulo, Brazil.

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

1 de enero de 2016

Finalización primaria (Actual)

1 de mayo de 2018

Finalización del estudio (Actual)

8 de octubre de 2018

Fechas de registro del estudio

Enviado por primera vez

14 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

1 de febrero de 2016

Publicado por primera vez (Estimar)

4 de febrero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

17 de abril de 2019

Última verificación

1 de octubre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Department of Neurology

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. .

Ensayos clínicos sobre Enfermedad de Parkinson

Ensayos clínicos sobre Gym Group

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Zimbabwe

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir