- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05004480
Influence of Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
Influence of Surgical Mask on Functional Capacity and Quality of Life During Controlled Endurance Exercise in Sedentary Adults
Descripción general del estudio
Descripción detallada
Group (A):
- Each subject will sign a consent form after receiving a detailed explanation about the procedure.
- Functional capacity and Quality of life will be evaluated before the start of the training.
- Subjects in group A will wear surgical mask before starting of the session. 4.3 sessions will be done every week for 3 months.
5.The session will start with warming up for 5 minutes then 25 minutes of aerobic exercise on the treadmill with moderate intensity followed by cooling down for 5 minutes.
6.After finishing the program, the participant will be evaluated to detect the effect of the exercise.
Group (B):
- Each subject will sign a consent form after receiving a detailed explanation about the procedure.
- Functional capacity and Quality of life will be evaluated before the start of the training.
- Subjects in group A will not wear any mask during the session. 4.3 sessions will be done every week for 3 months.
5.The session will start with warming up for 5 minutes then 25 minutes of aerobic exercise on the treadmill with moderate intensity followed by cooling down for 5 minutes.
6.After finishing the program, the participant will be evaluated to detect the effect of the exercise.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rana H El Banna, PHD
- Número de teléfono: 00201062070686
- Correo electrónico: rana.elbanna@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: Sherif O Elabd, master
- Número de teléfono: 0096871174218
- Correo electrónico: shiref.osama@yahoo.com
Ubicaciones de estudio
-
-
-
Giza, Egipto, 12613
- Reclutamiento
- Outpatient clinic faculty of physical therapy at Cairo University
-
Contacto:
- Mohamed O Hesham, PHD
- Número de teléfono: 00201067227404
- Correo electrónico: shiref.elabd@yahoo.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 100 participants
- 30 to 40 years of age
- both sex
Exclusion Criteria:
- uncontrolled cardiopulmonary conditions,
- sever un treated orthopedic condition
- uncontrolled neurological conditions,)
- uncontrolled diabetes,
- claustrophobia,
- pregnancy
- Recent COVID-19 infection,)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Surgical Mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill while wearing surgical mask
|
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
|
Experimental: Non mask Group
participants of both sexes who will perform controlled endurance exercise on treadmill without wearing surgical mask
|
Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Influence of surgical mask on Blood pressure during controlled endurance exercise in sedentary adults
Periodo de tiempo: three months
|
Measuring Blood pressure before and after the all program
|
three months
|
Influence of surgical mask on Resting and post exercise heart rate during controlled endurance exercise in sedentary adults
Periodo de tiempo: three months
|
Measuring Resting and post exercise heart rate before and after the all program
|
three months
|
Influence of surgical mask on resting and post exercise respiratory rate during controlled endurance exercise in sedentary adults
Periodo de tiempo: three months
|
Measuring resting and post exercise respiratory rate before and after the all program
|
three months
|
Influence of surgical mask on oxygen saturation, maximum oxygen consumption during controlled endurance exercise in sedentary adults
Periodo de tiempo: three months
|
Measuring oxygen saturation, maximum oxygen consumption before and after the all program
|
three months
|
Influence of surgical mask on quality of life during controlled endurance exercise in sedentary adults
Periodo de tiempo: three months
|
quality of life will be measured using short form quality of life 36 questionnaire, with score ranging from 0 to 100.
Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
|
three months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Influence of surgical mask on rate of perceived exertion during controlled endurance exercise in sedentary adults
Periodo de tiempo: three months
|
rate of perceived exertion will be measured by Borg scale with score ranged from 6-20 before and after intervention.
|
three months
|
Influence of surgical mask on submaximal exercise capacity during controlled endurance
Periodo de tiempo: three months
|
submaximal exercise capacity will be detected by six-minutes walking test and the distance which will be obtained will be measured by meter before and after the all program
|
three months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rana H El Banna, PHD, Outpatient clinic faculty of physical therapy at Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Otros números de identificación del estudio
- Personal (Ain Shams)
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. .
Ensayos clínicos sobre Treadmill
-
Assaf-Harofeh Medical CenterBen-Gurion University of the NegevDesconocidoParálisis Cerebral (PC)Israel