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PARQUE 70+ Studying Sleep Disorder

19 de agosto de 2019 actualizado por: Marcia Uchoa Rezende, University of Sao Paulo General Hospital
The emerging Brazilian population is accompanied by the emergence of patients in an age group, including osteoarthritis. Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases, affecting 4% of the Brazilian population. By 2050, 30% of Brazil's population is over 60 years old. This has a higher degree of elderly with morbades as unbass on the association, such as osteoarthritis. Proper management of OA involves educational program, multidisciplinary team care and therapeutic maneuvers with weight loss and maintenance of mobility. Insomnia is the most frequent sleep disorder in the elderly and its execution almost always harms young women. Sleep quality is interfered with fatigue and pain exacerbation in people with OA, ie a sleep approach should be diagnosed in patients with comorbidity. In addition, chronic patients usually have insomnia and pressure in the use of opioids, sedatives and antidepressants, pointing to insomnia and mood swings for polypharmacy. To evaluate a quality of sleep as an intervention of the PARQVE 70+ Project. Prospective, case-control study. Patients over 70 years old treated at a geriatric outpatient clinic with eye or polyarticular osteoarthesis and clinical OA treatment indicator will be allocated and matched in two groups of 30 elderly. Patients underwent Pittsburgh Sleep Quality Index questionnaires and the Epworth Scale before the study began, 3 and 6 months after PARQVE interventions and number of analysts, and compared those who did not perform an intervention. The study aims to improve sleep quality, decrease pain, reduce quality and decrease daytime sleepiness in elderly with OA.

Descripción general del estudio

Estado

Desconocido

Descripción detallada

The growing Brazilian population aging is accompanied by the emergence of common diseases in this age group, including osteoarthritis. Osteoarthritis (OA) is the most prevalent musculoskeletal disease, affecting 4% of the Brazilian population. There is important morbidity which progressively leads to chronic use of drugs harmful to this age group, such as anti-inflammatory drugs, increasing the risk of complications and pharmacological interactions. In addition to culminating with disabling functional impairment, osteoarthritis may progress, leading to the need for arthroplasty. Obesity and longevity are important risk factors for osteoarthritis, and both are very prevalent in Brazil.

2010 IBGE census progressions suggest a growing population increase, with 13% of the Brazilian population in 2018. By 2050, 30% of Brazil's population will be over 60 years old. This reflects a gradual increase in the elderly with common morbidities in this age group, such as osteoarthritis. Proper management of OA involves an educational program, multidisciplinary team care, and therapeutic measures aimed at weight loss and maintaining mobility.

Insomnia is the most frequent sleep disorder in the elderly and its prevalence almost doubles compared to young adults. In addition to aging, other factors such as the presence of clinical comorbidities, including OA, psychiatric disorders, primary sleep disorders and poor habits (poor sleep hygiene) contribute to this prevalence. During the aging process, in addition to increased nighttime awakenings and increased total waking time at night, there is a reduction in time spent in the deepest stages of sleep, which may be compromised in the presence of pain.

Sleep quality is affected by severe fatigue and pain exacerbation in people with OA, ie the sleep approach should always be considered in patients with such comorbidity. In addition to OA, patients with chronic pain usually have insomnia and depression, increasing the use of opioids, sedatives and antidepressants, indicating insomnia and mood changes contributing factors to polypharmacy.

A systematic review of chronic OA pain and spinal pain suggests that interventions such as cognitive behavioral therapy and sleep hygiene have good repercussions in people with OA.

The study of sleep improvement can facilitate the elderly's quality of life, decrease pain and reduce polypharmacy. This study aims to evaluate the improvement of sleep quality and decrease of daytime sleepiness in elderly with OA.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

60

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.

Estudio Contacto

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Classified as Kelgreen and Lawrence grades I to III (K-L), ie any degree of gonarthritis without obliteration of the joint space;
  • Indication of clinical treatment of OA;
  • Patients without moderate to advanced dementia syndrome;
  • Patients without neuropsychiatric diseases whose symptoms may impair the assimilation of the given guidelines.

Exclusion Criteria:

  • Missing interventions and not performing the tasks determined by professionals;
  • Patients with low family support;
  • Prescription in the last three months, during the study, some type of hypnotic or sleep inducing medication, which may interfere with the study analysis.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental
30 Patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times).
Two days of lectures about knee OA, come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved, participate in a group therapy session with the psychologists and sessions with the physical educators.
Comparador activo: Control
Should remain under geriatric care after randomization.
Remain under geriatric care as usual

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Evaluate changes in the quality of sleep after the multiprofessional intervention
Periodo de tiempo: 6 months
Answer questionnaires about sleep disorders - Ranges Min: 0 Better - Max: 24 Worse
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change of the insomnia severity index
Periodo de tiempo: Baseline, 3 months and 6 months
Answer insomnia severity index - Ranges Min: 0 Better - Max: 24 Worse
Baseline, 3 months and 6 months
Change of the Epworth Sleepiness Scale
Periodo de tiempo: Baseline, 3 months and 6 months
Answer Epworth Sleepiness Scale - Ranges Min: 0 Better - Max: 24 Worse
Baseline, 3 months and 6 months
Change of the subjective complaint of perception of sleep
Periodo de tiempo: Baseline, 3 months and 6 months
Answer the subjective complaint of perception of sleep - Ranges Min: 0 Better - Max: 24 Worse
Baseline, 3 months and 6 months
Change in the amount of pain medication
Periodo de tiempo: Baseline, 3 months and 6 months
Take notes day by day amount of medication
Baseline, 3 months and 6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Guilherme Ocampos, MD, University of Sao Paulo General Hospital

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.

Publicaciones Generales

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 (Anticipado)

1 de noviembre de 2019

Finalización primaria (Anticipado)

28 de febrero de 2020

Finalización del estudio (Anticipado)

31 de mayo de 2020

Fechas de registro del estudio

Enviado por primera vez

14 de agosto de 2019

Primero enviado que cumplió con los criterios de control de calidad

15 de agosto de 2019

Publicado por primera vez (Actual)

16 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de agosto de 2019

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

19 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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 PARQVE Program

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