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Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease (CKD) (SLIMM)

16 de septiembre de 2019 actualizado por: Srinvasan Beddhu

Sedentary behavior is engaging in activities in the seated or lying position that barely raise the energy expenditure level and has emerged as an important risk factor for obesity, diabetes, cardiovascular disease and mortality.

The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing casual walking duration and thereby, increase physical activity energy expenditure.

Descripción general del estudio

Estado

Terminado

Descripción detallada

There are an estimated 15.5 million adults with stage 3 chronic kidney disease (CKD) while only about 600,000 patients have end-stage renal disease (ESRD) in the United States. This is because most of the people with CKD die before they reach ESRD. In order to decrease the high mortality in the CKD population, the "non-renal" issues that contribute to increased morbidity and mortality in this population need to be addressed.

Relevance of sedentary behavior in CKD: Prolonged sitting time (as assessed by a questionnaire or television viewing time) was associated with lower kidney function. Total and light physical activities, measured objectively with an accelerometer were found to be positively associated with kidney function in a study of community dwelling adults. In an analysis of National Health and Nutrition Examination Survey (NHANES) data, it was noted that participants with CKD spent more than two-thirds of the awake time in sedentary activities and longer sedentary duration was associated with increased mortality. It was also noted in another study that compared to those with CKD, those on maintenance hemodialysis had 3.4 fold higher odds of being sedentary independent of demographics, co-morbidity, body size, serum C-Reactive Protein (CRP) and albumin. Thus, sedentary behavior is very common in CKD, appears to worsen with more advanced kidney failure and increases mortality risk in this population.

Feasibility of replacing sedentary activities with moderate/ vigorous physical activities: Moderate/ vigorous physical activities are less likely to be an effective replacement for sedentary activities as most Americans do not reach even the current goals and achieving the currently recommended levels of 2.5 hrs/ week of moderate/ vigorous activities would account only for 2% of the total awake time (112 hours/week). Therefore, decreasing sedentary activities must involve an increase in activities that are less intensive than moderate/ vigorous activities.

The concept of Non- Exercise Activity Thermogenesis (NEAT) and biological relevance of light intensity activity: In a overfeeding study, it was demonstrated that increase (average 336 kcal/day) in non- exercise activity thermogenesis accounted for 10-fold differences in fat storage, directly predicted resistance to fat gain and explained most of the variations in weight gain between participants. Obese persons have less non-exercise activity thermogenesis and spend an average of 2 hrs/d more in a seated position compared to lean persons. Objectively measured light activity was inversely associated with insulin resistance and cardiometabolic risk factors. Daily lifestyle activities were negatively associated with insulin resistance. Thus, replacing sedentary activities with non-exercise intensity activities of daily living could increase energy expenditure and decrease adiposity.

Determining what kind of light activity would be most beneficial in replacing sedentary activity: As standing (~ 1.5 Metabolic Equivalents of Task (METs)) is by definition non-sedentary (i.e. not sitting or lying down), one might consider replacing sitting duration with standing duration in order to decrease sedentary behavior. However, replacing sitting duration with casual walking (2 to 2.9 METs) duration might be even more beneficial. This notion is supported by the following theoretical calculations of energy expenditure. Assuming 16 hrs/day of awake time, it was calculated that the weekly energy expenditure for a person weighing 80 kg for trade-off of 1 to 5 min/hr of sedentary activity at 1.2 METs with 1.5 METs (standing intensity activities) or 2.5 METs (casual walking intensity activities). Additional kcal/week was calculated as the difference in energy expenditure between sedentary activity and 1.5 or 2.5 METs activity using the equation Kcal/ week = (METs/hr) x weight in kg X weekly duration of the physical activity. Trade-off of 1-5 min/hr of sedentary duration with standing intensity activities duration is expected to result in additional weekly expenditure of 50-250 Kcal only. On the other hand, similar trade off of sedentary duration with casual walking intensity activities duration is expected to result in ~ 200 to 1000 Kcal/ week of additional energy expenditure. This is consistent with prior observation that increase in non-exercise activities could lead to an additional 350 Kcal/d of energy expenditure in obese individuals.

Indeed, in the NHANES analyses, it was noted that trade-off sedentary duration for light intensity (2.0 to 2.9 METs) activities but not for very light intensity (1.5 to 1.9 METs) duration was associated with significantly lower risk of mortality. Thus, replacing sedentary duration with casual walking duration could increase energy expenditure and decrease mortality in CKD.

Tipo de estudio

Intervencionista

Inscripción (Actual)

106

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

    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84132
        • University of Utah

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Stage 3/4 Chronic Kidney Disease, as defined by estimated glomerular filtration rate (eGFR) 15 to < 60 ml/min/1.73m^2
  • Body Mass Index (BMI): 25 to 39.9 kg/m^2
  • Able to achieve gait speed of > 1 m/sec and able to walk ≥ 320 meters in the 6-minute walk test

Exclusion Criteria:

  • Previous renal replacement therapy
  • Life expectancy < 1 year
  • Pregnancy
  • Prison incarceration

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: SLIMM Intervention
Sit Less, Interact, Move More (SLIMM): instruction and monitoring feedback to promote decrease in sedentary activity duration, increase in casual walking duration, and increase in sedentary breaks
Sin intervención: Standard of Care
Subjects will receive standard of care treatment for chronic kidney disease, with no instruction or feedback to alter sedentary or casual walking durations

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Sedentary Activity Duration
Periodo de tiempo: Baseline and 24 Weeks
Change in sedentary activity duration (average sedentary minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks
Baseline and 24 Weeks
Change in Casual Walking Duration
Periodo de tiempo: Baseline and 24 Weeks
Change in casual walking activity duration (average walking minutes per hour), as measured by a validated accelerometry monitor from baseline to 24 weeks
Baseline and 24 Weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Waist Circumference
Periodo de tiempo: Baseline and 24 Weeks
Change in waist circumference, measured in centimeters, from baseline to 24 weeks
Baseline and 24 Weeks
Change in Non-Exercise Activity Thermogenesis
Periodo de tiempo: Baseline and 24 Weeks
Change in non-exercise activity thermogenesis, measured in kilocalorie/kilogram/hour, from baseline to 24 weeks
Baseline and 24 Weeks
Change in Physical Function
Periodo de tiempo: Baseline and 24 Weeks
Change in walking distance, measured in meters, using the 6-minute walk test from baseline to 24 weeks
Baseline and 24 Weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Srinivasan Beddhu, M.D., University of Utah

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 (Actual)

1 de diciembre de 2016

Finalización primaria (Actual)

12 de septiembre de 2019

Finalización del estudio (Actual)

12 de septiembre de 2019

Fechas de registro del estudio

Enviado por primera vez

17 de noviembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

17 de noviembre de 2016

Publicado por primera vez (Estimar)

21 de noviembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de septiembre de 2019

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

16 de septiembre de 2019

Última verificación

1 de septiembre de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB_00093477
  • 1R21DK106574-01A1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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. .

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