- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
29 april 2021 uppdaterad av: Mei-Wun Tsai, National Yang Ming University
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mei-Wun Tsai, Ph.D
- Telefonnummer: +886+2+28267939
- E-post: tmwk@ym.edu.tw
Studieorter
-
-
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Taipei, Taiwan, 112
- Rekrytering
- National Yang Ming University
-
Kontakt:
- Mei-Wun Tsai, Ph.D
-
Kontakt:
- Liang-Ying Lai
-
Huvudutredare:
- Liang-Ying Lai
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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vascular functions-Stiffness index(1)
Tidsram: 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)
Tidsram: during intervention(4th week)
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(Stiffness index, SI,unit:m/s)
|
during intervention(4th week)
|
|
vascular functions-Stiffness index(3)
Tidsram: post-intervention(8th week)
|
(Stiffness index, SI,unit:m/s)
|
post-intervention(8th week)
|
|
vascular functions-Reflective index(1)
Tidsram: pre-intervention(1st week)
|
(Reflective index, RI,unit:%)
|
pre-intervention(1st week)
|
|
vascular functions-Reflective index(2)
Tidsram: during intervention(4th week)
|
(Reflective index, RI,unit:%)
|
during intervention(4th week)
|
|
vascular functions-Reflective index(3)
Tidsram: post-intervention(8th week)
|
(Reflective index, RI,unit:%)
|
post-intervention(8th week)
|
|
vascular functions-Vascular age
Tidsram: pre-intervention(1st week)
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(Vascular age, VA,unit:year-old)
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pre-intervention(1st week)
|
|
Ultrasound parameters-peak-systolic velocity(1)
Tidsram: pre-intervention(1st week)
|
(peak-systolic velocity, PSV)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-peak-systolic velocity(2)
Tidsram: during intervention(4th week)
|
(peak-systolic velocity, PSV)
|
during intervention(4th week)
|
|
Ultrasound parameters-peak-systolic velocity(3)
Tidsram: post-intervention(8th week)
|
(peak-systolic velocity, PSV)
|
post-intervention(8th week)
|
|
Ultrasound parameters-end-diastolic velocity(1)
Tidsram: pre-intervention(1st week)
|
(end-diastolic velocity, EDV)
|
pre-intervention(1st week)
|
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Ultrasound parameters-end-diastolic velocity(2)
Tidsram: during intervention(4th week)
|
(end-diastolic velocity, EDV)
|
during intervention(4th week)
|
|
Ultrasound parameters-end-diastolic velocity(3)
Tidsram: post-intervention(8th week)
|
(end-diastolic velocity, EDV)
|
post-intervention(8th week)
|
|
Ultrasound parameters-mean velocity(1)
Tidsram: pre-intervention(1st week)
|
(mean velocity, mV)
|
pre-intervention(1st week)
|
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Ultrasound parameters-mean velocity(2)
Tidsram: during intervention(4th week)
|
(mean velocity, mV)
|
during intervention(4th week)
|
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Ultrasound parameters-mean velocity(3)
Tidsram: post-intervention(8th week)
|
(mean velocity, mV)
|
post-intervention(8th week)
|
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Ultrasound parameters-mean volume flow(1)
Tidsram: 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)
Tidsram: during intervention(4th week)
|
(mean volume flow, vFl)
|
during intervention(4th week)
|
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Ultrasound parameters-mean volume flow(3)
Tidsram: 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)
Tidsram: 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)
Tidsram: during intervention(4th week)
|
(resistance index, RI)
|
during intervention(4th week)
|
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Ultrasound parameters-resistance index(3)
Tidsram: post-intervention(8th week)
|
(resistance index, RI)
|
post-intervention(8th week)
|
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Ultrasound parameters-pulsatility index(1)
Tidsram: pre-intervention(1st week)
|
(pulsatility index, PI)
|
pre-intervention(1st week)
|
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Ultrasound parameters-pulsatility index(2)
Tidsram: during intervention(4th week)
|
(pulsatility index, PI)
|
during intervention(4th week)
|
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Ultrasound parameters-pulsatility index(3)
Tidsram: post-intervention(8th week)
|
(pulsatility index, PI)
|
post-intervention(8th week)
|
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Ultrasound parameters-diameter(1)
Tidsram: 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)
Tidsram: during intervention(4th week)
|
(diameter, D)
|
during intervention(4th week)
|
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Ultrasound parameters-diameter(3)
Tidsram: post-intervention(8th week)
|
(diameter, D)
|
post-intervention(8th week)
|
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Ultrasound parameters-area(1)
Tidsram: pre-intervention(1st week)
|
(area, A)
|
pre-intervention(1st week)
|
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Ultrasound parameters-area(2)
Tidsram: during intervention(4th week)
|
(area, A)
|
during intervention(4th week)
|
|
Ultrasound parameters-area(3)
Tidsram: post-intervention(8th week)
|
(area, A)
|
post-intervention(8th week)
|
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walking speed-preferred(1)
Tidsram: 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)
Tidsram: during intervention(4th week)
|
Timed 10-Meter Walk Test (preferred)
|
during intervention(4th week)
|
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walking speed-preferred(3)
Tidsram: post-intervention(8th week)
|
Timed 10-Meter Walk Test (preferred)
|
post-intervention(8th week)
|
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walking speed-fast(1)
Tidsram: pre-intervention(1st week)
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Timed 10-Meter Walk Test (fast)
|
pre-intervention(1st week)
|
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walking speed-fast(2)
Tidsram: during intervention(4th week)
|
Timed 10-Meter Walk Test (fast)
|
during intervention(4th week)
|
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walking speed-fast(3)
Tidsram: post-intervention(8th week)
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Timed 10-Meter Walk Test (fast)
|
post-intervention(8th week)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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body composition-height
Tidsram: pre-intervention(1st week)
|
height(cm)
|
pre-intervention(1st week)
|
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body composition-weight
Tidsram: pre-intervention(1st week)
|
weight(kg)
|
pre-intervention(1st week)
|
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body composition-waist circumference
Tidsram: pre-intervention(1st week)
|
waist circumference(cm)
|
pre-intervention(1st week)
|
|
vital sign-blood pressure(1)
Tidsram: pre-intervention(1st week)
|
blood pressure(mmHg)
|
pre-intervention(1st week)
|
|
vital sign-blood pressure(2)
Tidsram: during intervention(4th week)
|
blood pressure(mmHg)
|
during intervention(4th week)
|
|
vital sign-blood pressure(3)
Tidsram: post-intervention(8th week)
|
blood pressure(mmHg)
|
post-intervention(8th week)
|
|
vital sign-heart rate(1)
Tidsram: pre-intervention(1st week)
|
heart rate(bpm)
|
pre-intervention(1st week)
|
|
vital sign-heart rate(2)
Tidsram: during intervention(4th week)
|
heart rate(bpm)
|
during intervention(4th week)
|
|
vital sign-heart rate(3)
Tidsram: post-intervention(8th week)
|
heart rate(bpm)
|
post-intervention(8th week)
|
|
flexibility-chair sit and reach test (1)
Tidsram: pre-intervention(1st week)
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chair sit and reach test (cm)
|
pre-intervention(1st week)
|
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flexibility-chair sit and reach test (2)
Tidsram: during intervention(4th week)
|
chair sit and reach test (cm)
|
during intervention(4th week)
|
|
flexibility-chair sit and reach test (3)
Tidsram: post-intervention(8th week)
|
chair sit and reach test (cm)
|
post-intervention(8th week)
|
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grip strength
Tidsram: pre-intervention(1st week)
|
hand dynamometer
|
pre-intervention(1st week)
|
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cognitive function
Tidsram: 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)
|
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frailty
Tidsram: 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
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pre-intervention(1st week)
|
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basic data
Tidsram: pre-intervention(1st week)
|
gender, age, education, living status, smoking, and exercise habits
|
pre-intervention(1st week)
|
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ACSM-PAR-Q+
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: post-intervention(8th week)
|
usage records from the Line app
|
post-intervention(8th week)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Liang-Ying Lai, National Yang Ming University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2020
Primärt slutförande (Förväntat)
30 juni 2021
Avslutad studie (Förväntat)
30 juni 2021
Studieregistreringsdatum
Först inskickad
26 april 2021
Först inskickad som uppfyllde QC-kriterierna
29 april 2021
Första postat (Faktisk)
4 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- YM109100E
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