- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04099953
Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?
Atılım University, Physiotherapy and Rehabilitation Department
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ankara
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Gölbaşı, Ankara, Pavo, 06830
- Atılım University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
In study group,
- with cooperation
- hemodialysis treatment for at least 3 months
- with single-sided fistula
In the control group,
- healthy volunteers with no history of trauma or surgery in the upper extremity,
- with cooperating
Exclusion Criteria:
- Individuals with orthopedic problems associated with chronic renal failure,
- Upper limb functions affected
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: dialysis patients
Dialysis patients were evaluated by objective diagnostic tests.
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Hand grip force with Jamar Hand Dynamometer, joint range of motion with Baseline Digital Goniometer, functional level of the upper extremity with the Shoulder-Arm and Hand Problems Questionnaire(DASH), physical activity levels with International Physical Activity Questionnaire Short Form(IPAQ-short form) and physical functions with Human Activity Profile (HAP) were evaluated.
|
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Experimental: Control group
Healthy individuals
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Hand grip force with Jamar Hand Dynamometer, joint range of motion with Baseline Digital Goniometer, functional level of the upper extremity with the Shoulder-Arm and Hand Problems Questionnaire(DASH), physical activity levels with International Physical Activity Questionnaire Short Form(IPAQ-short form) and physical functions with Human Activity Profile (HAP) were evaluated.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of The Upper Extremity Functional Level
Periodo de tiempo: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
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Turkish version of the Shoulder, Arm and Hand Problems Questionnaire (The DASH-T) was used to asses the functional level of the upper extremity.
Turkish version of the shoulder, arm and hand problems questionnaire consists of 30 questions.
The first 20 questions are to examine physical competence, and the last 10 questions question pain and related functional and environmental constraints.
As the score is closer to zero, the functional level of the person is high; as the score is far from zero the functional level of the person is low .
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Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of Physical Activity Level
Periodo de tiempo: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
To asses the level of physical activity, The Turkish version of International Physical Activity Questionnaire Short Form was used .
In the turkish version of international physical activity questionnaire short form, physical activities were made at least 10 minutes at a time.
In the last 7 days of the survey; Severe physical activity duration (min), moderate physical activity duration (min), walking and one day sitting time (min) were questioned.
According to the total physical activity score, the physical activity levels of the participants were classified as low level (under 600 MET min /week), intermediate level (600-3000 MET-min /week) and high level (over 3000 MET-min / week) .
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Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
|
Evaluation of Physical Function Level
Periodo de tiempo: Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
The Human Activity Profile (HAP) was used to measure the physical function level. Human activity profile is a scale consisting of 94 items developed to determine the level of physical function in healthy individuals or individuals with chronic diseases at different ages . For each of the 94 items the respondent is asked to indicate whether they are still doing the activity, stopped doing the activity or have never done the activity before. Two scores are calculated: the maximum activity score (MAS) and the adjusted activity score (AAS). The physical activity level of the person is in one of 3 subgroups according to the adjusted activity score: <53 points: insufficient activity level, 53-74 points: moderately active and > 74 points: active . |
Evaluations were made after hemodialysis patients rested for half an hour after treatment.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Fatma Cansu AKTAŞ, MsC, Atılım University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 23/23
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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