- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01962597
Trial of Hemodialysis Based Exercise for Strength Improvement Study (THESIS)
Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.
Brief Summary:
Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:
(i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Hamilton, Ontario, Canadá, L8N 4A6
- St. Josephs Healthcare Hamilton
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At least 18 years of age
- On hemodialysis minimum of 3 times per week
- On hemodialysis > 3 consecutive months
Exclusion Criteria:
- Inability to provide consent
- Inability to walk 4-metres
- Chest pain with exertion or myocardial infarction in past 6-months
- Pre-dialysis systolic blood pressure > 200 mm Hg or diastolic BP > 100 mm Hg in past 2-weeks
- Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
- Joint replacement or lower extremity fracture in previous 6-months
- Severe cognitive impairment
- Currently using corticosteroids >5 mg/day
- Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
- Attending nephrologist feels exercise is medically contraindicated
- Scheduled living related kidney transplant in next 6 months
Plan de estudios
¿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 |
---|---|
Comparador activo: aerobic exercise
patients will undergo supervised exercise on a bike ergometer for 30 minutes three times per week during hemodialysis
|
|
Comparador activo: resistance training
patients will undergo supervised lower extremity strength training three times per week pre-hemodialysis
|
|
Experimental: aerobic exercise and resistance training
patients will undergo a combination of aerobic exercise and resistance training on an alternating schedule three time per week
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in walking speed over 20 weeks
Periodo de tiempo: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change in short physical performance battery over 20 weeks
Periodo de tiempo: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
change in EuroQOL-5D-5L over 20 weeks
Periodo de tiempo: 10 and 20 weeks
|
Health-related quality of life.
Repeated measures analysis
|
10 and 20 weeks
|
change in dialysis recovery time over 20 weeks
Periodo de tiempo: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
change in Nottingham extended activities of daily living index over 20 weeks
Periodo de tiempo: 10 and 20 weeks
|
repeated measures analysis
|
10 and 20 weeks
|
change in body anthropometry and composition over 20 weeks.
Periodo de tiempo: 10 and 20 weeks
|
weight, waist-hip ratio, bioimpedance analysis-determined fat-free mass, percentage body fat, phase angle.
Repeated measures analysis
|
10 and 20 weeks
|
change in inflammation measures over 20 weeks
Periodo de tiempo: 10 and 20 weeks
|
serum albumin, C-reactive protein, interleukin-6 and tumor necrosis factor-alpha.
Repeated measures analysis
|
10 and 20 weeks
|
hospitalization
Periodo de tiempo: continuous over 20 weeks
|
continuous over 20 weeks
|
|
death
Periodo de tiempo: continuous over 20 weeks
|
continuous over 20 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-468
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