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- Klinische proef NCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
29 april 2021 bijgewerkt door: Mei-Wun Tsai, National Yang Ming University
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Mei-Wun Tsai, Ph.D
- Telefoonnummer: +886+2+28267939
- E-mail: tmwk@ym.edu.tw
Studie Locaties
-
-
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Taipei, Taiwan, 112
- Werving
- National Yang Ming University
-
Contact:
- Mei-Wun Tsai, Ph.D
-
Contact:
- Liang-Ying Lai
-
Hoofdonderzoeker:
- Liang-Ying Lai
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
vascular functions-Stiffness index(1)
Tijdsspanne: pre-intervention(1st week)
|
(Stiffness index, SI,unit:m/s)
|
pre-intervention(1st week)
|
vascular functions-Stiffness index(2)
Tijdsspanne: during intervention(4th week)
|
(Stiffness index, SI,unit:m/s)
|
during intervention(4th week)
|
vascular functions-Stiffness index(3)
Tijdsspanne: post-intervention(8th week)
|
(Stiffness index, SI,unit:m/s)
|
post-intervention(8th week)
|
vascular functions-Reflective index(1)
Tijdsspanne: pre-intervention(1st week)
|
(Reflective index, RI,unit:%)
|
pre-intervention(1st week)
|
vascular functions-Reflective index(2)
Tijdsspanne: during intervention(4th week)
|
(Reflective index, RI,unit:%)
|
during intervention(4th week)
|
vascular functions-Reflective index(3)
Tijdsspanne: post-intervention(8th week)
|
(Reflective index, RI,unit:%)
|
post-intervention(8th week)
|
vascular functions-Vascular age
Tijdsspanne: pre-intervention(1st week)
|
(Vascular age, VA,unit:year-old)
|
pre-intervention(1st week)
|
Ultrasound parameters-peak-systolic velocity(1)
Tijdsspanne: pre-intervention(1st week)
|
(peak-systolic velocity, PSV)
|
pre-intervention(1st week)
|
Ultrasound parameters-peak-systolic velocity(2)
Tijdsspanne: during intervention(4th week)
|
(peak-systolic velocity, PSV)
|
during intervention(4th week)
|
Ultrasound parameters-peak-systolic velocity(3)
Tijdsspanne: post-intervention(8th week)
|
(peak-systolic velocity, PSV)
|
post-intervention(8th week)
|
Ultrasound parameters-end-diastolic velocity(1)
Tijdsspanne: pre-intervention(1st week)
|
(end-diastolic velocity, EDV)
|
pre-intervention(1st week)
|
Ultrasound parameters-end-diastolic velocity(2)
Tijdsspanne: during intervention(4th week)
|
(end-diastolic velocity, EDV)
|
during intervention(4th week)
|
Ultrasound parameters-end-diastolic velocity(3)
Tijdsspanne: post-intervention(8th week)
|
(end-diastolic velocity, EDV)
|
post-intervention(8th week)
|
Ultrasound parameters-mean velocity(1)
Tijdsspanne: pre-intervention(1st week)
|
(mean velocity, mV)
|
pre-intervention(1st week)
|
Ultrasound parameters-mean velocity(2)
Tijdsspanne: during intervention(4th week)
|
(mean velocity, mV)
|
during intervention(4th week)
|
Ultrasound parameters-mean velocity(3)
Tijdsspanne: post-intervention(8th week)
|
(mean velocity, mV)
|
post-intervention(8th week)
|
Ultrasound parameters-mean volume flow(1)
Tijdsspanne: pre-intervention(1st week)
|
(mean volume flow, vFl)
|
pre-intervention(1st week)
|
Ultrasound parameters-mean volume flow(2)
Tijdsspanne: during intervention(4th week)
|
(mean volume flow, vFl)
|
during intervention(4th week)
|
Ultrasound parameters-mean volume flow(3)
Tijdsspanne: post-intervention(8th week)
|
(mean volume flow, vFl)
|
post-intervention(8th week)
|
Ultrasound parameters-resistance index(1)
Tijdsspanne: pre-intervention(1st week)
|
(resistance index, RI)
|
pre-intervention(1st week)
|
Ultrasound parameters-resistance index(2)
Tijdsspanne: during intervention(4th week)
|
(resistance index, RI)
|
during intervention(4th week)
|
Ultrasound parameters-resistance index(3)
Tijdsspanne: post-intervention(8th week)
|
(resistance index, RI)
|
post-intervention(8th week)
|
Ultrasound parameters-pulsatility index(1)
Tijdsspanne: pre-intervention(1st week)
|
(pulsatility index, PI)
|
pre-intervention(1st week)
|
Ultrasound parameters-pulsatility index(2)
Tijdsspanne: during intervention(4th week)
|
(pulsatility index, PI)
|
during intervention(4th week)
|
Ultrasound parameters-pulsatility index(3)
Tijdsspanne: post-intervention(8th week)
|
(pulsatility index, PI)
|
post-intervention(8th week)
|
Ultrasound parameters-diameter(1)
Tijdsspanne: pre-intervention(1st week)
|
(diameter, D)
|
pre-intervention(1st week)
|
Ultrasound parameters-diameter(2)
Tijdsspanne: during intervention(4th week)
|
(diameter, D)
|
during intervention(4th week)
|
Ultrasound parameters-diameter(3)
Tijdsspanne: post-intervention(8th week)
|
(diameter, D)
|
post-intervention(8th week)
|
Ultrasound parameters-area(1)
Tijdsspanne: pre-intervention(1st week)
|
(area, A)
|
pre-intervention(1st week)
|
Ultrasound parameters-area(2)
Tijdsspanne: during intervention(4th week)
|
(area, A)
|
during intervention(4th week)
|
Ultrasound parameters-area(3)
Tijdsspanne: post-intervention(8th week)
|
(area, A)
|
post-intervention(8th week)
|
walking speed-preferred(1)
Tijdsspanne: pre-intervention(1st week)
|
Timed 10-Meter Walk Test (preferred)
|
pre-intervention(1st week)
|
walking speed-preferred(2)
Tijdsspanne: during intervention(4th week)
|
Timed 10-Meter Walk Test (preferred)
|
during intervention(4th week)
|
walking speed-preferred(3)
Tijdsspanne: post-intervention(8th week)
|
Timed 10-Meter Walk Test (preferred)
|
post-intervention(8th week)
|
walking speed-fast(1)
Tijdsspanne: pre-intervention(1st week)
|
Timed 10-Meter Walk Test (fast)
|
pre-intervention(1st week)
|
walking speed-fast(2)
Tijdsspanne: during intervention(4th week)
|
Timed 10-Meter Walk Test (fast)
|
during intervention(4th week)
|
walking speed-fast(3)
Tijdsspanne: post-intervention(8th week)
|
Timed 10-Meter Walk Test (fast)
|
post-intervention(8th week)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
body composition-height
Tijdsspanne: pre-intervention(1st week)
|
height(cm)
|
pre-intervention(1st week)
|
body composition-weight
Tijdsspanne: pre-intervention(1st week)
|
weight(kg)
|
pre-intervention(1st week)
|
body composition-waist circumference
Tijdsspanne: pre-intervention(1st week)
|
waist circumference(cm)
|
pre-intervention(1st week)
|
vital sign-blood pressure(1)
Tijdsspanne: pre-intervention(1st week)
|
blood pressure(mmHg)
|
pre-intervention(1st week)
|
vital sign-blood pressure(2)
Tijdsspanne: during intervention(4th week)
|
blood pressure(mmHg)
|
during intervention(4th week)
|
vital sign-blood pressure(3)
Tijdsspanne: post-intervention(8th week)
|
blood pressure(mmHg)
|
post-intervention(8th week)
|
vital sign-heart rate(1)
Tijdsspanne: pre-intervention(1st week)
|
heart rate(bpm)
|
pre-intervention(1st week)
|
vital sign-heart rate(2)
Tijdsspanne: during intervention(4th week)
|
heart rate(bpm)
|
during intervention(4th week)
|
vital sign-heart rate(3)
Tijdsspanne: post-intervention(8th week)
|
heart rate(bpm)
|
post-intervention(8th week)
|
flexibility-chair sit and reach test (1)
Tijdsspanne: pre-intervention(1st week)
|
chair sit and reach test (cm)
|
pre-intervention(1st week)
|
flexibility-chair sit and reach test (2)
Tijdsspanne: during intervention(4th week)
|
chair sit and reach test (cm)
|
during intervention(4th week)
|
flexibility-chair sit and reach test (3)
Tijdsspanne: post-intervention(8th week)
|
chair sit and reach test (cm)
|
post-intervention(8th week)
|
grip strength
Tijdsspanne: pre-intervention(1st week)
|
hand dynamometer
|
pre-intervention(1st week)
|
cognitive function
Tijdsspanne: pre-intervention(1st week)
|
Montreal Cognitive Assessment.Minimum value is 0 and maximum value is 30, and higher scores mean a better outcome
|
pre-intervention(1st week)
|
frailty
Tijdsspanne: pre-intervention(1st week)
|
SOF (Study of Osteoporotic Fractures).
Minimum value is 0 and maximum value is 3, and higher scores mean a worse outcome
|
pre-intervention(1st week)
|
basic data
Tijdsspanne: pre-intervention(1st week)
|
gender, age, education, living status, smoking, and exercise habits
|
pre-intervention(1st week)
|
ACSM-PAR-Q+
Tijdsspanne: pre-intervention(1st week)
|
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.
|
pre-intervention(1st week)
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IPAQ
Tijdsspanne: pre-intervention(1st week)
|
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).
|
pre-intervention(1st week)
|
fitness
Tijdsspanne: pre-intervention(1st week)
|
(Duke activity status index, DASI) Minimum value is 0 and maximum value is 58.2, and higher scores mean a better physical activity level.
|
pre-intervention(1st week)
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adherence of exercise
Tijdsspanne: post-intervention(8th week)
|
usage records from the Line app
|
post-intervention(8th week)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Liang-Ying Lai, National Yang Ming University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2020
Primaire voltooiing (Verwacht)
30 juni 2021
Studie voltooiing (Verwacht)
30 juni 2021
Studieregistratiedata
Eerst ingediend
26 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2021
Eerst geplaatst (Werkelijk)
4 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 mei 2021
Laatste update ingediend die voldeed aan QC-criteria
29 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- YM109100E
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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