- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
April 29, 2021 updated by: Mei-Wun Tsai, National Yang Ming University
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mei-Wun Tsai, Ph.D
- Phone Number: +886+2+28267939
- Email: tmwk@ym.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 112
- Recruiting
- National Yang Ming University
-
Contact:
- Mei-Wun Tsai, Ph.D
-
Contact:
- Liang-Ying Lai
-
Principal Investigator:
- Liang-Ying Lai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
No Intervention: Control group
Maintain their daily activity level in the 8 weeks.
We use the study desigh-''waiting list control'' in this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vascular functions-Stiffness index(1)
Time Frame: pre-intervention(1st week)
|
(Stiffness index, SI,unit:m/s)
|
pre-intervention(1st week)
|
|
vascular functions-Stiffness index(2)
Time Frame: during intervention(4th week)
|
(Stiffness index, SI,unit:m/s)
|
during intervention(4th week)
|
|
vascular functions-Stiffness index(3)
Time Frame: post-intervention(8th week)
|
(Stiffness index, SI,unit:m/s)
|
post-intervention(8th week)
|
|
vascular functions-Reflective index(1)
Time Frame: pre-intervention(1st week)
|
(Reflective index, RI,unit:%)
|
pre-intervention(1st week)
|
|
vascular functions-Reflective index(2)
Time Frame: during intervention(4th week)
|
(Reflective index, RI,unit:%)
|
during intervention(4th week)
|
|
vascular functions-Reflective index(3)
Time Frame: post-intervention(8th week)
|
(Reflective index, RI,unit:%)
|
post-intervention(8th week)
|
|
vascular functions-Vascular age
Time Frame: pre-intervention(1st week)
|
(Vascular age, VA,unit:year-old)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-peak-systolic velocity(1)
Time Frame: pre-intervention(1st week)
|
(peak-systolic velocity, PSV)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-peak-systolic velocity(2)
Time Frame: during intervention(4th week)
|
(peak-systolic velocity, PSV)
|
during intervention(4th week)
|
|
Ultrasound parameters-peak-systolic velocity(3)
Time Frame: post-intervention(8th week)
|
(peak-systolic velocity, PSV)
|
post-intervention(8th week)
|
|
Ultrasound parameters-end-diastolic velocity(1)
Time Frame: pre-intervention(1st week)
|
(end-diastolic velocity, EDV)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-end-diastolic velocity(2)
Time Frame: during intervention(4th week)
|
(end-diastolic velocity, EDV)
|
during intervention(4th week)
|
|
Ultrasound parameters-end-diastolic velocity(3)
Time Frame: post-intervention(8th week)
|
(end-diastolic velocity, EDV)
|
post-intervention(8th week)
|
|
Ultrasound parameters-mean velocity(1)
Time Frame: pre-intervention(1st week)
|
(mean velocity, mV)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-mean velocity(2)
Time Frame: during intervention(4th week)
|
(mean velocity, mV)
|
during intervention(4th week)
|
|
Ultrasound parameters-mean velocity(3)
Time Frame: post-intervention(8th week)
|
(mean velocity, mV)
|
post-intervention(8th week)
|
|
Ultrasound parameters-mean volume flow(1)
Time Frame: pre-intervention(1st week)
|
(mean volume flow, vFl)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-mean volume flow(2)
Time Frame: during intervention(4th week)
|
(mean volume flow, vFl)
|
during intervention(4th week)
|
|
Ultrasound parameters-mean volume flow(3)
Time Frame: post-intervention(8th week)
|
(mean volume flow, vFl)
|
post-intervention(8th week)
|
|
Ultrasound parameters-resistance index(1)
Time Frame: pre-intervention(1st week)
|
(resistance index, RI)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-resistance index(2)
Time Frame: during intervention(4th week)
|
(resistance index, RI)
|
during intervention(4th week)
|
|
Ultrasound parameters-resistance index(3)
Time Frame: post-intervention(8th week)
|
(resistance index, RI)
|
post-intervention(8th week)
|
|
Ultrasound parameters-pulsatility index(1)
Time Frame: pre-intervention(1st week)
|
(pulsatility index, PI)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-pulsatility index(2)
Time Frame: during intervention(4th week)
|
(pulsatility index, PI)
|
during intervention(4th week)
|
|
Ultrasound parameters-pulsatility index(3)
Time Frame: post-intervention(8th week)
|
(pulsatility index, PI)
|
post-intervention(8th week)
|
|
Ultrasound parameters-diameter(1)
Time Frame: pre-intervention(1st week)
|
(diameter, D)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-diameter(2)
Time Frame: during intervention(4th week)
|
(diameter, D)
|
during intervention(4th week)
|
|
Ultrasound parameters-diameter(3)
Time Frame: post-intervention(8th week)
|
(diameter, D)
|
post-intervention(8th week)
|
|
Ultrasound parameters-area(1)
Time Frame: pre-intervention(1st week)
|
(area, A)
|
pre-intervention(1st week)
|
|
Ultrasound parameters-area(2)
Time Frame: during intervention(4th week)
|
(area, A)
|
during intervention(4th week)
|
|
Ultrasound parameters-area(3)
Time Frame: post-intervention(8th week)
|
(area, A)
|
post-intervention(8th week)
|
|
walking speed-preferred(1)
Time Frame: pre-intervention(1st week)
|
Timed 10-Meter Walk Test (preferred)
|
pre-intervention(1st week)
|
|
walking speed-preferred(2)
Time Frame: during intervention(4th week)
|
Timed 10-Meter Walk Test (preferred)
|
during intervention(4th week)
|
|
walking speed-preferred(3)
Time Frame: post-intervention(8th week)
|
Timed 10-Meter Walk Test (preferred)
|
post-intervention(8th week)
|
|
walking speed-fast(1)
Time Frame: pre-intervention(1st week)
|
Timed 10-Meter Walk Test (fast)
|
pre-intervention(1st week)
|
|
walking speed-fast(2)
Time Frame: during intervention(4th week)
|
Timed 10-Meter Walk Test (fast)
|
during intervention(4th week)
|
|
walking speed-fast(3)
Time Frame: post-intervention(8th week)
|
Timed 10-Meter Walk Test (fast)
|
post-intervention(8th week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body composition-height
Time Frame: pre-intervention(1st week)
|
height(cm)
|
pre-intervention(1st week)
|
|
body composition-weight
Time Frame: pre-intervention(1st week)
|
weight(kg)
|
pre-intervention(1st week)
|
|
body composition-waist circumference
Time Frame: pre-intervention(1st week)
|
waist circumference(cm)
|
pre-intervention(1st week)
|
|
vital sign-blood pressure(1)
Time Frame: pre-intervention(1st week)
|
blood pressure(mmHg)
|
pre-intervention(1st week)
|
|
vital sign-blood pressure(2)
Time Frame: during intervention(4th week)
|
blood pressure(mmHg)
|
during intervention(4th week)
|
|
vital sign-blood pressure(3)
Time Frame: post-intervention(8th week)
|
blood pressure(mmHg)
|
post-intervention(8th week)
|
|
vital sign-heart rate(1)
Time Frame: pre-intervention(1st week)
|
heart rate(bpm)
|
pre-intervention(1st week)
|
|
vital sign-heart rate(2)
Time Frame: during intervention(4th week)
|
heart rate(bpm)
|
during intervention(4th week)
|
|
vital sign-heart rate(3)
Time Frame: post-intervention(8th week)
|
heart rate(bpm)
|
post-intervention(8th week)
|
|
flexibility-chair sit and reach test (1)
Time Frame: pre-intervention(1st week)
|
chair sit and reach test (cm)
|
pre-intervention(1st week)
|
|
flexibility-chair sit and reach test (2)
Time Frame: during intervention(4th week)
|
chair sit and reach test (cm)
|
during intervention(4th week)
|
|
flexibility-chair sit and reach test (3)
Time Frame: post-intervention(8th week)
|
chair sit and reach test (cm)
|
post-intervention(8th week)
|
|
grip strength
Time Frame: pre-intervention(1st week)
|
hand dynamometer
|
pre-intervention(1st week)
|
|
cognitive function
Time Frame: 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
Time Frame: 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
Time Frame: pre-intervention(1st week)
|
gender, age, education, living status, smoking, and exercise habits
|
pre-intervention(1st week)
|
|
ACSM-PAR-Q+
Time Frame: 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)
|
|
IPAQ
Time Frame: 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
Time Frame: 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)
|
|
adherence of exercise
Time Frame: post-intervention(8th week)
|
usage records from the Line app
|
post-intervention(8th week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Liang-Ying Lai, National Yang Ming University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
April 26, 2021
First Submitted That Met QC Criteria
April 29, 2021
First Posted (Actual)
May 4, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- YM109100E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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