- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
29. april 2021 oppdatert av: Mei-Wun Tsai, National Yang Ming University
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Forventet)
48
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mei-Wun Tsai, Ph.D
- Telefonnummer: +886+2+28267939
- E-post: tmwk@ym.edu.tw
Studiesteder
-
-
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Taipei, Taiwan, 112
- Rekruttering
- National Yang Ming University
-
Ta kontakt med:
- Mei-Wun Tsai, Ph.D
-
Ta kontakt med:
- Liang-Ying Lai
-
Hovedetterforsker:
- Liang-Ying Lai
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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vascular functions-Stiffness index(1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: post-intervention(8th week)
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(Stiffness index, SI,unit:m/s)
|
post-intervention(8th week)
|
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vascular functions-Reflective index(1)
Tidsramme: pre-intervention(1st week)
|
(Reflective index, RI,unit:%)
|
pre-intervention(1st week)
|
|
vascular functions-Reflective index(2)
Tidsramme: during intervention(4th week)
|
(Reflective index, RI,unit:%)
|
during intervention(4th week)
|
|
vascular functions-Reflective index(3)
Tidsramme: post-intervention(8th week)
|
(Reflective index, RI,unit:%)
|
post-intervention(8th week)
|
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vascular functions-Vascular age
Tidsramme: 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)
Tidsramme: pre-intervention(1st week)
|
(peak-systolic velocity, PSV)
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pre-intervention(1st week)
|
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Ultrasound parameters-peak-systolic velocity(2)
Tidsramme: 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)
Tidsramme: post-intervention(8th week)
|
(peak-systolic velocity, PSV)
|
post-intervention(8th week)
|
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Ultrasound parameters-end-diastolic velocity(1)
Tidsramme: pre-intervention(1st week)
|
(end-diastolic velocity, EDV)
|
pre-intervention(1st week)
|
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Ultrasound parameters-end-diastolic velocity(2)
Tidsramme: during intervention(4th week)
|
(end-diastolic velocity, EDV)
|
during intervention(4th week)
|
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Ultrasound parameters-end-diastolic velocity(3)
Tidsramme: post-intervention(8th week)
|
(end-diastolic velocity, EDV)
|
post-intervention(8th week)
|
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Ultrasound parameters-mean velocity(1)
Tidsramme: pre-intervention(1st week)
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(mean velocity, mV)
|
pre-intervention(1st week)
|
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Ultrasound parameters-mean velocity(2)
Tidsramme: during intervention(4th week)
|
(mean velocity, mV)
|
during intervention(4th week)
|
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Ultrasound parameters-mean velocity(3)
Tidsramme: post-intervention(8th week)
|
(mean velocity, mV)
|
post-intervention(8th week)
|
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Ultrasound parameters-mean volume flow(1)
Tidsramme: pre-intervention(1st week)
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(mean volume flow, vFl)
|
pre-intervention(1st week)
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Ultrasound parameters-mean volume flow(2)
Tidsramme: during intervention(4th week)
|
(mean volume flow, vFl)
|
during intervention(4th week)
|
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Ultrasound parameters-mean volume flow(3)
Tidsramme: post-intervention(8th week)
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(mean volume flow, vFl)
|
post-intervention(8th week)
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Ultrasound parameters-resistance index(1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: post-intervention(8th week)
|
(resistance index, RI)
|
post-intervention(8th week)
|
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Ultrasound parameters-pulsatility index(1)
Tidsramme: pre-intervention(1st week)
|
(pulsatility index, PI)
|
pre-intervention(1st week)
|
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Ultrasound parameters-pulsatility index(2)
Tidsramme: during intervention(4th week)
|
(pulsatility index, PI)
|
during intervention(4th week)
|
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Ultrasound parameters-pulsatility index(3)
Tidsramme: post-intervention(8th week)
|
(pulsatility index, PI)
|
post-intervention(8th week)
|
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Ultrasound parameters-diameter(1)
Tidsramme: 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)
Tidsramme: during intervention(4th week)
|
(diameter, D)
|
during intervention(4th week)
|
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Ultrasound parameters-diameter(3)
Tidsramme: post-intervention(8th week)
|
(diameter, D)
|
post-intervention(8th week)
|
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Ultrasound parameters-area(1)
Tidsramme: 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)
Tidsramme: during intervention(4th week)
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(area, A)
|
during intervention(4th week)
|
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Ultrasound parameters-area(3)
Tidsramme: post-intervention(8th week)
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(area, A)
|
post-intervention(8th week)
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walking speed-preferred(1)
Tidsramme: 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)
Tidsramme: during intervention(4th week)
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Timed 10-Meter Walk Test (preferred)
|
during intervention(4th week)
|
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walking speed-preferred(3)
Tidsramme: post-intervention(8th week)
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Timed 10-Meter Walk Test (preferred)
|
post-intervention(8th week)
|
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walking speed-fast(1)
Tidsramme: 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)
Tidsramme: during intervention(4th week)
|
Timed 10-Meter Walk Test (fast)
|
during intervention(4th week)
|
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walking speed-fast(3)
Tidsramme: post-intervention(8th week)
|
Timed 10-Meter Walk Test (fast)
|
post-intervention(8th week)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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body composition-height
Tidsramme: pre-intervention(1st week)
|
height(cm)
|
pre-intervention(1st week)
|
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body composition-weight
Tidsramme: pre-intervention(1st week)
|
weight(kg)
|
pre-intervention(1st week)
|
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body composition-waist circumference
Tidsramme: pre-intervention(1st week)
|
waist circumference(cm)
|
pre-intervention(1st week)
|
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vital sign-blood pressure(1)
Tidsramme: pre-intervention(1st week)
|
blood pressure(mmHg)
|
pre-intervention(1st week)
|
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vital sign-blood pressure(2)
Tidsramme: during intervention(4th week)
|
blood pressure(mmHg)
|
during intervention(4th week)
|
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vital sign-blood pressure(3)
Tidsramme: post-intervention(8th week)
|
blood pressure(mmHg)
|
post-intervention(8th week)
|
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vital sign-heart rate(1)
Tidsramme: pre-intervention(1st week)
|
heart rate(bpm)
|
pre-intervention(1st week)
|
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vital sign-heart rate(2)
Tidsramme: during intervention(4th week)
|
heart rate(bpm)
|
during intervention(4th week)
|
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vital sign-heart rate(3)
Tidsramme: post-intervention(8th week)
|
heart rate(bpm)
|
post-intervention(8th week)
|
|
flexibility-chair sit and reach test (1)
Tidsramme: pre-intervention(1st week)
|
chair sit and reach test (cm)
|
pre-intervention(1st week)
|
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flexibility-chair sit and reach test (2)
Tidsramme: during intervention(4th week)
|
chair sit and reach test (cm)
|
during intervention(4th week)
|
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flexibility-chair sit and reach test (3)
Tidsramme: post-intervention(8th week)
|
chair sit and reach test (cm)
|
post-intervention(8th week)
|
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grip strength
Tidsramme: pre-intervention(1st week)
|
hand dynamometer
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pre-intervention(1st week)
|
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cognitive function
Tidsramme: pre-intervention(1st week)
|
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
Tidsramme: 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)
|
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basic data
Tidsramme: pre-intervention(1st week)
|
gender, age, education, living status, smoking, and exercise habits
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pre-intervention(1st week)
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ACSM-PAR-Q+
Tidsramme: 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.
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pre-intervention(1st week)
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IPAQ
Tidsramme: 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)
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fitness
Tidsramme: 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.
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pre-intervention(1st week)
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adherence of exercise
Tidsramme: post-intervention(8th week)
|
usage records from the Line app
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post-intervention(8th week)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Liang-Ying Lai, National Yang Ming University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2020
Primær fullføring (Forventet)
30. juni 2021
Studiet fullført (Forventet)
30. juni 2021
Datoer for studieregistrering
Først innsendt
26. april 2021
Først innsendt som oppfylte QC-kriteriene
29. april 2021
Først lagt ut (Faktiske)
4. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- YM109100E
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