- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01443455
Adherence and Health Effects of Video Dance in Postmenopausal Women
Phase 2 Trial of Video Dance Versus Walking in Postmenopausal Sedentary Overweight Women
This is a 6 month randomized clinical trial comparing video dance, brisk walking and delayed entry controls. The interventions have two phases; a 12 week initiation phase with substantial structure and supervision, followed by a 12 week transition phase, with reduced structure and supervision. Participants are 168 overweight or obese, sedentary postmenopausal women aged 50 to 65; 60 in each exercise arm and 48 in the wait list control group.
The following research questions will be assessed:
- Is exercise adherence at 6 months better with video dance games compared to brisk walking?
- Does video dance game exercise compared to wait list controls, induce beneficial changes in physical and mental health?
- Does video dance game exercise compared to brisk walking better promote balance, attention and visual spatial skills, without loss of benefit to cardiovascular fitness?
- Is video dance preferred to brisk walking for exercise among postmenopausal women? If so, who and why?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants must be female
- age 50-65
- not currently exercising at least 20 minutes
- three times per week
- a BMI of 25 or higher
Exclusion Criteria:
- Exclusions are largely related to medical safety and include history of osteoporosis, osteoporotic fractures, active cardiovascular disease, uncontrolled hypertension, weight bearing pain that would limit exercise, seizure disorder or any medical condition or medication that would limit the safety of the study.
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: VideoDance
|
Using a commercially available product called Dance Dance Revolution (DDR) this video-game based dancing system uses a game player, force sensing pad and software.
The step sequences are set to a wide range of music and become more complex and frequent as the dancer gains skill.
Participants are oriented over 2 weeks.
For the rest of the first 3 months, the participant attends at least one supervised session per week.
Participants may use the center for additional, unsupervised sessions and/or they can take a dance system home.
They also receive brief behavioral intervention sessions for safety orientation, exercise education and adherence promotion.
For the following 3 months, the participant enters the transition phase in which she is encouraged to continue to exercise but no formal supervision is provided.
Otros nombres:
|
Comparador activo: Brisk Walking
|
The overall goal is to increase the duration and speed of walking, using structure and supervision for the first three months, followed by reduced support in the second three months.
For the first two weeks, each participant comes to the center at least twice a week to walk.They are encouraged to gradually increase effort and duration to a target of 150 minutes per week of brisk walking.Participants are taught to use Borg's ratings of perceived exertion and self-monitored heart rate to target their level of activity.
The next 10 weeks include once weekly supervised sessions and additional sessions either at the center or in preferred community settings.
The recommended goal is a minimum of 150 minutes per week of exercise in sessions of at least 10 -15 minutes duration.Participants are given pedometers in order to help them monitor their progress.
After 12 weeks, the participant enters a transition phase for a further 3 months.
|
Otro: Delayed entry control
Participants who are randomized to the delayed entry non-exercise control group receive the American Heart Association pamphlet, but no direct support for exercise implementation.
After they have completed six months of follow up, they are invited to select any combination of dancing and walking that they prefer and then receive support and instruction according to the protocols described above.
|
Participants who are randomized to the delayed entry non-exercise control group receive the American Heart Association pamphlet, but no direct support for exercise implementation. After they have completed six months of follow up, they are invited to select any combination of dancing and walking that they prefer and then receive support and instruction according to the protocols described above. -------------------------------------------------------------------------------- |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adherence
Periodo de tiempo: six months after randomization
|
minutes per week of moderate or greater physical exercise activity assessed using accelerometers and activity diaries
|
six months after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Endurance
Periodo de tiempo: 3 and 6 months
|
timed 2 km walk
|
3 and 6 months
|
body composition
Periodo de tiempo: 6 months
|
Lunar Prodigy DXA scanner for lean body mass and total fat mass
|
6 months
|
vascular health
Periodo de tiempo: 6 months
|
blood pressure, pulse, lipid levels, fasting glucose, fasting insulin and C reactive protein
|
6 months
|
balance
Periodo de tiempo: 3 and 6 months
|
timed one foot stand and timed narrow walk
|
3 and 6 months
|
personality
Periodo de tiempo: baseline
|
NEO Personality Inventory
|
baseline
|
sleep quality
Periodo de tiempo: 3 and 6 monhts
|
Pittsburgh Sleep Quality Index
|
3 and 6 monhts
|
visuospatial/constructional function
Periodo de tiempo: 3 and 6 monhts
|
domain of the Repeatable Battery for the Assessment of Neuropsychological Status
|
3 and 6 monhts
|
attention domain
Periodo de tiempo: 3 and 6 monhts
|
subtests of the Repeatable Battery for the Assessment of Neuropsychological Status
|
3 and 6 monhts
|
Useful Field of View
Periodo de tiempo: 3 and 6 monhts
|
Useful Field of View test
|
3 and 6 monhts
|
step reaction time
Periodo de tiempo: 3 and 6 months
|
Step Reaction Tasks
|
3 and 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Stephanie A Studenski, MD MPH, University of Pittsburgh
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 (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
Otros números de identificación del estudio
- PRO08080012
- P30AG024827 (Subvención/contrato del NIH de EE. UU.)
- T32AG021885 (Subvención/contrato del NIH 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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