- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03853668
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting (exercises)
Descripción general del estudio
Descripción detallada
OBJECTIVE/BACKGROUND:
There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the cardiac population. Thus, the objective of the present study was to compare the quality of sleep in subjects who underwent coronary artery bypass surgery submitted to two types of training (ie, aerobic exercise alone or combined aerobic and resistance training).
PATIENTS/METHODS:
80 Participants aged 45-65 years were randomized to two groups: aerobic group (AG), combined aerobic and resistance group (ARG). Training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one minute intervals. The participants kept the device for a period of 96 hours before the first and last training sessions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo
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Giza, Cairo, Egipto, 11262
- National Heart Institute
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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:
- Patients who have underwent CABG surgery since 6-8 weeks
- Their ages ranges from 40 and 80 years of age
- Medically stable patients.
- patients did CABG-only treatment (not combined with valve replacement surgery)
- Current complaint of poor Sleep quality (SQ) (score > 5 of the SQ scale)
- Body mass index ≤ 35 kg/m2 (no obstructive sleep apnea)
Exclusion Criteria:
- Any patient is known to have any unstable medical condition
- History of chronic insomnia for at least one year before surgery
- Indication of receiving treatments for depression and anxiety
- Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: aerobic exercise group
aerobic exercises (intervention) on treadmill for 10 weeks, 3 times/week for duration of 30-45 min/session. Exercise intensity is 50-65%of maximal heart rate (MHR) |
control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
Otros nombres:
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Experimental: aerobic and resisted exercise
combined resisted and aerobic exercises (intervention) for 10 weeks (circuit weight training and treadmill training respectively) 2 times/week for a duration of 30-45 min/session Exercise intensity is 50-65%of maximal heart rate (MHR) for aerobic part and 50% of 1 repetition maximum (1RM) for resistance part.
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control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
sleep quality to be assessed by Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: up to 12 months
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1.The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
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up to 12 months
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sleep fragmentation index to be assessed by actigraphy
Periodo de tiempo: up to 12 months
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2.Actigraphy is a valid tool to assist in determining sleep patterns in normal, healthy adult populations, normal infants and children, and patients suspected of certain sleep disorders.
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up to 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functional aerobic capacity to be assessed by 6 minute walk test (6MWT)
Periodo de tiempo: 6 months
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The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hady Atef, Master, Assistant lecturer of physical therapy,Cairo 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
- Sleep and Exercise
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.
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