- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
29 de abril de 2021 actualizado por: Mei-Wun Tsai, National Yang Ming University
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Descripción general del estudio
Descripción detallada
This study examines the relationship between circulations and walking speeds.
Most studies in the field of stretching exercises have only focused on improvements of endothelial functions in younger population; however, I aim to emphasize its effects on different populations, such as people with frailty, low physical activity level, weakness and postoperative status.
Previous research has established that stretching exercises can improve walking function by modulations of musculoskeletal or neuromuscular system.
The importance and originality of this study are that it explores the relationship between circulation and walking speed.
Due to the inability to extrapolate outcomes; short-term effect of improved blood vessel function; the unclear mechanism of stretching exercises; and considering the different physical fitness groups, I design a home-based, low-dose, and anatomic chain-based stretching exercises to verify the possible mechanism and effects.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
48
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mei-Wun Tsai, Ph.D
- Número de teléfono: +886+2+28267939
- Correo electrónico: tmwk@ym.edu.tw
Ubicaciones de estudio
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Taipei, Taiwán, 112
- Reclutamiento
- National Yang Ming University
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Contacto:
- Mei-Wun Tsai, Ph.D
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Contacto:
- Liang-Ying Lai
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Investigador principal:
- Liang-Ying Lai
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- age between 20-85 years old
- Follow instructions
- Walk with/without assistive technology
Exclusion Criteria:
- Unstable acute or chronic health conditions
- Peripheral vascular diseases
- Non-musculoskeletal problems that would limit stretching exercises
- Participate in other exercise programs
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Stretching exercises
Interventions are home-based stretching exercises.
The experimental group will receive 6 stretching exercises which stretch 20-30 seconds, relax for 10 seconds, and repeat 5 times for each side.
It will take 25-30 minutes every day for continuous 8 weeks.
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Our interventions are home-based stretching exercises.
The experimental group will receive 6 stretching exercises which stretch 20-30 seconds, relax for 10 seconds, and repeat 5 times for each side.
It will take 25-30 minutes every day for continuous 8 weeks.
Those include stretching of the deep front line, spiral line, superficial front line, lateral line, superficial back line, and plantar flexors.
Designed concepts are the following three: 1) based on ''Anatomy- Train'' theory, 2) emphasize on movements of trunk and pelvis, and 3) stress on the stretching of lower extremities.
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Sin intervención: Control group
Maintain their daily activity level in the 8 weeks.
We use the study desigh-''waiting list control'' in this group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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vascular functions-Stiffness index(1)
Periodo de tiempo: pre-intervention(1st week)
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(Stiffness index, SI,unit:m/s)
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pre-intervention(1st week)
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vascular functions-Stiffness index(2)
Periodo de tiempo: during intervention(4th week)
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(Stiffness index, SI,unit:m/s)
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during intervention(4th week)
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vascular functions-Stiffness index(3)
Periodo de tiempo: post-intervention(8th week)
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(Stiffness index, SI,unit:m/s)
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post-intervention(8th week)
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vascular functions-Reflective index(1)
Periodo de tiempo: pre-intervention(1st week)
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(Reflective index, RI,unit:%)
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pre-intervention(1st week)
|
|
vascular functions-Reflective index(2)
Periodo de tiempo: during intervention(4th week)
|
(Reflective index, RI,unit:%)
|
during intervention(4th week)
|
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vascular functions-Reflective index(3)
Periodo de tiempo: post-intervention(8th week)
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(Reflective index, RI,unit:%)
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post-intervention(8th week)
|
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vascular functions-Vascular age
Periodo de tiempo: pre-intervention(1st week)
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(Vascular age, VA,unit:year-old)
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pre-intervention(1st week)
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Ultrasound parameters-peak-systolic velocity(1)
Periodo de tiempo: pre-intervention(1st week)
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(peak-systolic velocity, PSV)
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pre-intervention(1st week)
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Ultrasound parameters-peak-systolic velocity(2)
Periodo de tiempo: during intervention(4th week)
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(peak-systolic velocity, PSV)
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during intervention(4th week)
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Ultrasound parameters-peak-systolic velocity(3)
Periodo de tiempo: post-intervention(8th week)
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(peak-systolic velocity, PSV)
|
post-intervention(8th week)
|
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Ultrasound parameters-end-diastolic velocity(1)
Periodo de tiempo: pre-intervention(1st week)
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(end-diastolic velocity, EDV)
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pre-intervention(1st week)
|
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Ultrasound parameters-end-diastolic velocity(2)
Periodo de tiempo: during intervention(4th week)
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(end-diastolic velocity, EDV)
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during intervention(4th week)
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Ultrasound parameters-end-diastolic velocity(3)
Periodo de tiempo: post-intervention(8th week)
|
(end-diastolic velocity, EDV)
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post-intervention(8th week)
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Ultrasound parameters-mean velocity(1)
Periodo de tiempo: pre-intervention(1st week)
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(mean velocity, mV)
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pre-intervention(1st week)
|
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Ultrasound parameters-mean velocity(2)
Periodo de tiempo: during intervention(4th week)
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(mean velocity, mV)
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during intervention(4th week)
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Ultrasound parameters-mean velocity(3)
Periodo de tiempo: post-intervention(8th week)
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(mean velocity, mV)
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post-intervention(8th week)
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Ultrasound parameters-mean volume flow(1)
Periodo de tiempo: pre-intervention(1st week)
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(mean volume flow, vFl)
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pre-intervention(1st week)
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Ultrasound parameters-mean volume flow(2)
Periodo de tiempo: during intervention(4th week)
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(mean volume flow, vFl)
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during intervention(4th week)
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Ultrasound parameters-mean volume flow(3)
Periodo de tiempo: post-intervention(8th week)
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(mean volume flow, vFl)
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post-intervention(8th week)
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Ultrasound parameters-resistance index(1)
Periodo de tiempo: pre-intervention(1st week)
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(resistance index, RI)
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pre-intervention(1st week)
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Ultrasound parameters-resistance index(2)
Periodo de tiempo: during intervention(4th week)
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(resistance index, RI)
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during intervention(4th week)
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Ultrasound parameters-resistance index(3)
Periodo de tiempo: post-intervention(8th week)
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(resistance index, RI)
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post-intervention(8th week)
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Ultrasound parameters-pulsatility index(1)
Periodo de tiempo: pre-intervention(1st week)
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(pulsatility index, PI)
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pre-intervention(1st week)
|
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Ultrasound parameters-pulsatility index(2)
Periodo de tiempo: during intervention(4th week)
|
(pulsatility index, PI)
|
during intervention(4th week)
|
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Ultrasound parameters-pulsatility index(3)
Periodo de tiempo: post-intervention(8th week)
|
(pulsatility index, PI)
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post-intervention(8th week)
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Ultrasound parameters-diameter(1)
Periodo de tiempo: pre-intervention(1st week)
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(diameter, D)
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pre-intervention(1st week)
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Ultrasound parameters-diameter(2)
Periodo de tiempo: during intervention(4th week)
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(diameter, D)
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during intervention(4th week)
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Ultrasound parameters-diameter(3)
Periodo de tiempo: post-intervention(8th week)
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(diameter, D)
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post-intervention(8th week)
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Ultrasound parameters-area(1)
Periodo de tiempo: pre-intervention(1st week)
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(area, A)
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pre-intervention(1st week)
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Ultrasound parameters-area(2)
Periodo de tiempo: during intervention(4th week)
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(area, A)
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during intervention(4th week)
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Ultrasound parameters-area(3)
Periodo de tiempo: post-intervention(8th week)
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(area, A)
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post-intervention(8th week)
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walking speed-preferred(1)
Periodo de tiempo: pre-intervention(1st week)
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Timed 10-Meter Walk Test (preferred)
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pre-intervention(1st week)
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walking speed-preferred(2)
Periodo de tiempo: during intervention(4th week)
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Timed 10-Meter Walk Test (preferred)
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during intervention(4th week)
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walking speed-preferred(3)
Periodo de tiempo: post-intervention(8th week)
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Timed 10-Meter Walk Test (preferred)
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post-intervention(8th week)
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walking speed-fast(1)
Periodo de tiempo: pre-intervention(1st week)
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Timed 10-Meter Walk Test (fast)
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pre-intervention(1st week)
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walking speed-fast(2)
Periodo de tiempo: during intervention(4th week)
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Timed 10-Meter Walk Test (fast)
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during intervention(4th week)
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walking speed-fast(3)
Periodo de tiempo: post-intervention(8th week)
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Timed 10-Meter Walk Test (fast)
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post-intervention(8th week)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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body composition-height
Periodo de tiempo: pre-intervention(1st week)
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height(cm)
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pre-intervention(1st week)
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body composition-weight
Periodo de tiempo: pre-intervention(1st week)
|
weight(kg)
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pre-intervention(1st week)
|
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body composition-waist circumference
Periodo de tiempo: pre-intervention(1st week)
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waist circumference(cm)
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pre-intervention(1st week)
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vital sign-blood pressure(1)
Periodo de tiempo: pre-intervention(1st week)
|
blood pressure(mmHg)
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pre-intervention(1st week)
|
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vital sign-blood pressure(2)
Periodo de tiempo: during intervention(4th week)
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blood pressure(mmHg)
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during intervention(4th week)
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vital sign-blood pressure(3)
Periodo de tiempo: post-intervention(8th week)
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blood pressure(mmHg)
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post-intervention(8th week)
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vital sign-heart rate(1)
Periodo de tiempo: pre-intervention(1st week)
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heart rate(bpm)
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pre-intervention(1st week)
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vital sign-heart rate(2)
Periodo de tiempo: during intervention(4th week)
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heart rate(bpm)
|
during intervention(4th week)
|
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vital sign-heart rate(3)
Periodo de tiempo: post-intervention(8th week)
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heart rate(bpm)
|
post-intervention(8th week)
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flexibility-chair sit and reach test (1)
Periodo de tiempo: pre-intervention(1st week)
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chair sit and reach test (cm)
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pre-intervention(1st week)
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flexibility-chair sit and reach test (2)
Periodo de tiempo: during intervention(4th week)
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chair sit and reach test (cm)
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during intervention(4th week)
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flexibility-chair sit and reach test (3)
Periodo de tiempo: post-intervention(8th week)
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chair sit and reach test (cm)
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post-intervention(8th week)
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grip strength
Periodo de tiempo: pre-intervention(1st week)
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hand dynamometer
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pre-intervention(1st week)
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cognitive function
Periodo de tiempo: pre-intervention(1st week)
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Montreal Cognitive Assessment.Minimum value is 0 and maximum value is 30, and higher scores mean a better outcome
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pre-intervention(1st week)
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frailty
Periodo de tiempo: pre-intervention(1st week)
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SOF (Study of Osteoporotic Fractures).
Minimum value is 0 and maximum value is 3, and higher scores mean a worse outcome
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pre-intervention(1st week)
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basic data
Periodo de tiempo: pre-intervention(1st week)
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gender, age, education, living status, smoking, and exercise habits
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pre-intervention(1st week)
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ACSM-PAR-Q+
Periodo de tiempo: pre-intervention(1st week)
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The Physical Activity Readiness Questionnaire for Everyone AND follow-up questions about their medical conditions (PAR-Q+) is used to identify whether subjects are at risk in engaging in exercises.
Thus, researchers can prescribe individual exercise prescriptions.
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pre-intervention(1st week)
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IPAQ
Periodo de tiempo: pre-intervention(1st week)
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International Physical Activity Questionnaire to investigate their physical activity levels.
Higher the amount of physical activity (min-METs/week) means a more active life-style(physical activity level).
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pre-intervention(1st week)
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fitness
Periodo de tiempo: pre-intervention(1st week)
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(Duke activity status index, DASI) Minimum value is 0 and maximum value is 58.2, and higher scores mean a better physical activity level.
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pre-intervention(1st week)
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adherence of exercise
Periodo de tiempo: post-intervention(8th week)
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usage records from the Line app
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post-intervention(8th week)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Liang-Ying Lai, National Yang Ming University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2020
Finalización primaria (Anticipado)
30 de junio de 2021
Finalización del estudio (Anticipado)
30 de junio de 2021
Fechas de registro del estudio
Enviado por primera vez
26 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2021
Publicado por primera vez (Actual)
4 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- YM109100E
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .