- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02757456
Exercise and Vascular Parameters in Hemodialysis
Aerobic Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators propose a pilot project to assess the effect of a 16 week aerobic exercise program on arterial stiffness and cardiovascular risk in the hemodialysis population. The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter. The secondary objectives will assess the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP, hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin, hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.
Study Design:
Randomized-controlled study of end stage renal disease patients between the age of 18 and 90 years to assess the effect of exercise on arterial stiffness. Our aim is to have 23 patients in both groups. The study period will be 24 weeks-4 weeks for recruitment, 16 weeks for the intervention and 4 weeks for data collection and analysis. The protocol will be submitted to the MUHC Research Ethics Board.
The following outcomes are of interest:
- change in gait speed before and after the exercise program
- change in pulse wave velocity before and after the exercise program
- change in BNP, blood pressure, dialysis ultrafiltration, hemoglobin, micro RNAs before and after the exercise program
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Montreal, Quebec, Canadá, H3A 1A1
- Royal Victoria Hospital
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female, aged 18-95 years
- Able to comply with the study procedures and medication
- Written informed consent given
- On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment
- Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program
Exclusion Criteria:
- Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment
- Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia
- Serum iPTH > 250 pmol/L within 30 days prior to screening visit
- Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to recruitment
- Severe peripheral vascular disease
- Severe hyperkalemia (>6.5 mmol/L) consistently for the last 2 weeks
- Current active cancer (excluding basal cell carcinoma of the skin)
- Poorly controlled hypertension (systolic > 180mmHg or diastolic > 100mmHg) within 4 weeks prior to recruitment
- Anticipated live donor kidney transplant or any other planned major surgery over the study duration
- History of poor adherence to hemodialysis or medical regimen
- Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Aerobic Exercise program
Intervention of aerobic exercise
|
The 16-week program will consist of aerobic-type steady-state or interval exercises using a pedals attachable to the dialysis chairs.
The purpose will be to slowly increase exercise duration by 5 minute increments to reach the goal of 30 min/treatment.
The exercise program during hemodialysis sessions will contain a combination of aerobic and flexibility exercises, about 30 minutes of cycling with 10 minutes of warm up/stretching exercises and 10-15 minutes cool down.
The frequency of exercise will be three sessions a week, during the first hour of dialysis treatment for the duration of 16 weeks.
Blood pressure and heart continuous monitoring will be carried out during the exercise program.
Exercise log sheets will be filled for each session for the 16 weeks.
|
Otro: Control
no aerobic exercise program
|
No aerobic exercise is offered but baseline and end of study testing of the outcomes occur
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Baseline in Gait speed
Periodo de tiempo: at 24 weeks and 48 weeks
|
The gait speed will be measured with a timer (in seconds) as the subject will be asked to walk a 10 foot or 3 meter course and back as quickly as possible.
Two readings will be taken and the average will be recorded.
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at 24 weeks and 48 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Baseline Pulse wave velocity (PWV)
Periodo de tiempo: at 24 weeks and 48 weeks
|
PWV measurements will be performed between the carotid and femoral artery sites, to primarily measure the stiffness of the aorta.
A 3-lead ECG will be used in conjunction with a tonometer to measure the pressure pulse waveform sequentially in the two peripheral artery sites
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at 24 weeks and 48 weeks
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Change from Baseline Pulse wave analysis
Periodo de tiempo: at 24 and 48 weeks
|
Wave Reflections and Arterial Stiffness.
Analysis of the systolic part of the central pressure waveform will be performed to evaluate PWV and the LV afterload.
The main indices that were described above (in hemodynamic measurements) will be obtained by aortic PWA.
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at 24 and 48 weeks
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Change from baseline Rand survey
Periodo de tiempo: at 24 weeks and 48 weeks
|
RAND 36-item survey will be used to assess physical functioning and fatigue.
This survey has been validated in the Hemodialysis population.
The survey consists of 36 items and takes approximately 5-10 minutes to complete.
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at 24 weeks and 48 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change from baseline micro RNA levels
Periodo de tiempo: at 24 weeks and 48 weeks
|
micro RNAs (21, 126, 133, 146a, 221/222 and 210): blood sample will be taken before initiation of dialysis week of baseline measurements and end of study.
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at 24 weeks and 48 weeks
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change from baseline Brain Natuiretic Peptide
Periodo de tiempo: at 24 weeks and 48 weeks
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Brain Natuiretic Peptide: measure before initiation of dialysis at baseline and at the end of study period.
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at 24 weeks and 48 weeks
|
change from baseline troponin levels
Periodo de tiempo: at 24 weeks and 48 weeks
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to assess myocardial injury during dialysis at baseline and at the end of the study
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at 24 weeks and 48 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sameena Iqbal, McGill University Health Centre/Research Institute of the McGill University Health Centre
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 (Actual)
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
- 12-309-GEN
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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