Physical Activity and Functioning in Home Dialysis Patients
Descripción general del estudio
Descripción detallada
Aim 1: To determine levels of physical functioning, physical activity, incidence of frailty and inflammation status in prevalent home dialysis patients in the University of Utah Home Dialysis program and compare them to in-center hemodialysis patients who are matched for age, gender, comorbidities and dialysis vintage. Hypothesis 1: Patients on home therapies will have higher physical functioning, be more active and fewer will be frail compared to matched patients treated with in-center hemodialysis.
Aim 2: To determine the patterns of change in physical functioning and physical activity over the first 18 months of initiating dialysis therapy. Hypothesis 2: Physical functioning and physical activity will be maintained in patients initiating home dialysis therapy, whereas, those initiating in-center dialysis will deteriorate in physical functioning and physical activity.
Aim 3: To determine the effects of counseling and encouragement of physical activity in prevalent home dialysis patients on physical functioning, physical activity. Hypothesis 3: Compared to usual care, patients who are counseled and encouraged to participate in independent home walking exercise will improve physical functioning and health-related quality of life.
Aim 4: To determine the association of inflammation with physical functioning in home dialysis patients and with changes in physical activity. Hypothesis 4: Lower physical functioning is associated with inflammation and increased physical activity will improve physical functioning and reduce the associated inflammation.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- on dialysis for 3 months (for prospective study and for pilot intervention)
- 18 years of age
- ambulatory
- no progressive neuromuscular disease
- no orthopedic or rheumatologic problems that would be exacerbated by physical function testing
- English speaking
- able to understand and provide consent for participation
Exclusion Criteria:
- progressive neuromuscular disease that may result in limitations
- orthopedic or rheumatologic disease that may be exacerbated by physical function testing
- physical functioning
- unstable angina or angina upon exertion
- terminal illness with life expectancy less than 12 months
- MI or CABG within the last year
- NYHA Class III or IV CHF
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Physical Function/Activity
cross-sectional comparison study of physical function/activity, frailty and inflammation measures in prevalent home Dx and prevalent in-center hemodialysis patients. Subjects: Forty-five prevalent home dialysis patients will be recruited and tested once for all outcome measures. Forty-five prevalent in-center hemodialysis patients will be identified from prevalent patients in the University of Utah in-center dialysis system who are matched for gender, age, comorbidities and time on dialysis as the home dialysis patients who have been tested. Consenting patients will be tested for all outcome measures once and compared to the home dialysis group. |
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Sin intervención: Incident Patients
Study 2: is a longitudinal cohort study of incident patients starting either home dialysis or in-center hemodialysis. Consenting patients will be tested upon initiation of dialysis therapy and every 6 months for 18 months to track physical functioning /activity, frailty and inflammation over time. |
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Otro: Independent Home Exercise
pilot study of independent home exercise training in home dialysis (PD only) patients.
Consenting patients will be tested at baseline, then randomized into exercise training or usual care (no prescribed change in activity levels) and retested after 3 months.
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Pilot study of independent home exercise training (walking or cycling exercise plus low level resistance exercise) for 3 months.
Patients will be given specific recommendations for type, frequency, duration and progression of their program and will be contacted weekly by study staff to assess progress and evaluation for any problems.
This is a 3 month exercise training intervention in 15 subjects (and 15 no-exercise controls).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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change in short physical performance battery
Periodo de tiempo: baseline, 3 months, 6 months 12 mo, 18 mo
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baseline, 3 months, 6 months 12 mo, 18 mo
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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change in inflammation
Periodo de tiempo: baseline, 6 mo, 12 mo, 18 mo
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baseline, 6 mo, 12 mo, 18 mo
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patricia Painter, U of U PHYSICAL THERAPY - COH
Publicaciones y enlaces útiles
Publicaciones Generales
- Painter P, Carlson L, Carey S, Paul SM, Myll J. Physical functioning and health-related quality-of-life changes with exercise training in hemodialysis patients. Am J Kidney Dis. 2000 Mar;35(3):482-92. doi: 10.1016/s0272-6386(00)70202-2.
- Lo CY, Li L, Lo WK, Chan ML, So E, Tang S, Yuen MC, Cheng IK, Chan TM. Benefits of exercise training in patients on continuous ambulatory peritoneal dialysis. Am J Kidney Dis. 1998 Dec;32(6):1011-8. doi: 10.1016/s0272-6386(98)70076-9.
- Painter P, Messer-Rehak D, Hanson P, Zimmerman SW, Glass NR. Exercise capacity in hemodialysis, CAPD, and renal transplant patients. Nephron. 1986;42(1):47-51. doi: 10.1159/000183632.
- Cheema BS, Singh MA. Exercise training in patients receiving maintenance hemodialysis: a systematic review of clinical trials. Am J Nephrol. 2005 Jul-Aug;25(4):352-64. doi: 10.1159/000087184. Epub 2005 Jul 22.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- IRB_00053828
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