- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03155750
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course.
Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8.
Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training or SHE groups in a 1: 1 ratio.
Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.
Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training group.
Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx will be evaluated.
Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Hong Kong, Hong Kong
- School of Nursing, The Hong Kong Polytechnic University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults age 18-65 years old;
- Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
- A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months;
- Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
- Willing to give informed consent and comply with the trial protocol;
- Ambulant and independent in activities of daily living;
- Physically inactive which refers to less than 150 minutes moderate-intensity activity per week or less than 75 minutes vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous- intensity activity.
Exclusion Criteria:
- Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;
- Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
- Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
- cognitive impairment preventing informed consent or understanding of instructions (score < 22 in Montreal Cognitive Assessment Hong Kong version);
- Shift work;
- body mass index equal to or over 27.5, the obese criteria for Asians;
- Unsafe conditions or incapable to exercise as recommended by their physician.
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 |
|---|---|
|
Experimental: Zero Time Exercise training
Subjects in this group will attend two 2-hour ZTEx training lessons.
Each subject will receive a handout and an exercise log.
The handout includes a picture-illustrating ZTEx step-by-step protocol.
The exercise log is for them to record their time spending on performing the ZTEx every day during the 8-week study period.
|
Zero Time Exercise alienta a las personas a aumentar el ejercicio físico mediante movimientos simples que se pueden realizar en cualquier momento y en cualquier lugar.
Ofrecemos un curso de formación de 2 sesiones para entrenar a los sujetos para hacer ejercicio de tiempo cero.
|
|
Comparador activo: sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
|
Ofrecemos un curso educativo de 2 sesiones para enseñar a los sujetos sobre la práctica de la higiene del sueño.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Insomnia Severity Index
Periodo de tiempo: week 8
|
The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
|
week 8
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep diary (7-day)
Periodo de tiempo: Baseline, week 4, week 8
|
The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.
|
Baseline, week 4, week 8
|
|
Multidimensional fatigue inventory-20
Periodo de tiempo: Baseline, week 4, week 8
|
Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
|
Baseline, week 4, week 8
|
|
Hospital Anxiety and Depression Scale
Periodo de tiempo: Baseline, week 4, week 8
|
The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms
|
Baseline, week 4, week 8
|
|
Actigraphy (7-day)
Periodo de tiempo: Baseline, week 8
|
Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device
|
Baseline, week 8
|
|
Short Form-6 Dimension
Periodo de tiempo: Baseline, week 4, week 8
|
The Short Form-6 Dimension is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis.
|
Baseline, week 4, week 8
|
|
Hand grip strength
Periodo de tiempo: Baseline, week 8
|
Objective hand grip strength
|
Baseline, week 8
|
|
Level of activity
Periodo de tiempo: Baseline, week4, week 8
|
Self-report level of activity in moderate and vigorous intensity
|
Baseline, week4, week 8
|
|
Weight
Periodo de tiempo: Baseline, week 8
|
Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
|
Baseline, week 8
|
|
Height
Periodo de tiempo: Baseline, week 8
|
Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)
|
Baseline, week 8
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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
- ZTEInsomnia
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. .
Ensayos clínicos sobre Ejercicio de tiempo cero
-
The Hong Kong Polytechnic UniversityTerminadoInsomnio PrimarioHong Kong
-
GE HealthcareTerminadoImagen mental | Imágenes de cuerpo enteroEstados Unidos
-
Synthes USA HQ, Inc.TerminadoEnfermedad del disco cervicalEstados Unidos
-
University of RijekaPharmamedMado d.o.o., Zagreb, CroatiaDesconocidoHipotermia | Signos y síntomas | Hemorragia intracerebral primariaCroacia
-
Aalborg University HospitalLund University; Catholic University of the Sacred Heart; University of Lausanne... y otros colaboradoresDesconocidoDolor del miembro fantasmaDinamarca
-
Oregon Research Behavioral Intervention Strategies...Oregon Research InstituteTerminadoRelaciones familiares | Relaciones entre hermanosEstados Unidos
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute... y otros colaboradoresTerminadoCarrera | Actividades de la vida diaria | Limitación de movilidad | EquilibrioCanadá
-
Medical College of WisconsinAún no reclutandoDiabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes tipo 1 | Edulcorante No NutritivoEstados Unidos
-
University Hospital, Clermont-FerrandService Biologie de la reproduction-CECOSDesconocidoParámetros espermáticos | Cinética embrionariaFrancia
-
Sohag UniversityAún no reclutando