StretchNCT04871906
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
A study testing stretching exercises in people with Stretch, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stretch
- What is being tested?
- stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 20-85 years old
- Follow instructions
- Walk with/without assistive technology
Who cannot join
- Unstable acute or chronic health conditions
- Peripheral vascular diseases
- Non-musculoskeletal problems that would limit stretching exercises
- Participate in other exercise programs
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming University
Taipei, 112
Mei-Wun Tsai, Ph.D
Liang-Ying Lai
About this study
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
Read the 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.
- Conditions
- Stretch
- Being tested
- stretching exercises
- Keywords
- stretching exercise, vascular function, blood flow, walking function, fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stretching exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stretching exercises | Experimental | 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. Receives: Other: stretching exercises |
| Control group | No intervention | Maintain their daily activity level in the 8 weeks. We use the study desigh-''waiting list control'' in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular functions-Stiffness index(1)
(Stiffness index, SI，unit：m/s)
Measured: pre-intervention(1st week)
vascular functions-Stiffness index(2)
(Stiffness index, SI，unit：m/s)
Measured: during intervention(4th week)
vascular functions-Stiffness index(3)
(Stiffness index, SI，unit：m/s)
Measured: post-intervention(8th week)
vascular functions-Reflective index(1)
(Reflective index, RI，unit：％)
Measured: pre-intervention(1st week)
vascular functions-Reflective index(2)
(Reflective index, RI，unit：％)
Measured: during intervention(4th week)
vascular functions-Reflective index(3)
(Reflective index, RI，unit：％)
Measured: post-intervention(8th week)
vascular functions-Vascular age
(Vascular age, VA，unit：year-old)
Measured: pre-intervention(1st week)
Ultrasound parameters-peak-systolic velocity(1)
（peak-systolic velocity, PSV)
Measured: pre-intervention(1st week)
Ultrasound parameters-peak-systolic velocity(2)
（peak-systolic velocity, PSV）
Measured: during intervention(4th week)
Ultrasound parameters-peak-systolic velocity(3)
（peak-systolic velocity, PSV）
Measured: post-intervention(8th week)
Ultrasound parameters-end-diastolic velocity(1)
（end-diastolic velocity, EDV）
Measured: pre-intervention(1st week)
Ultrasound parameters-end-diastolic velocity(2)
（end-diastolic velocity, EDV）
Measured: during intervention(4th week)
Ultrasound parameters-end-diastolic velocity(3)
（end-diastolic velocity, EDV）
Measured: post-intervention(8th week)
Ultrasound parameters-mean velocity(1)
（mean velocity, mV）
Measured: pre-intervention(1st week)
Ultrasound parameters-mean velocity(2)
（mean velocity, mV）
Measured: during intervention(4th week)
Ultrasound parameters-mean velocity(3)
（mean velocity, mV）
Measured: post-intervention(8th week)
Ultrasound parameters-mean volume flow(1)
(mean volume flow, vFl)
Measured: pre-intervention(1st week)
Ultrasound parameters-mean volume flow(2)
(mean volume flow, vFl)
Measured: during intervention(4th week)
Ultrasound parameters-mean volume flow(3)
(mean volume flow, vFl)
Measured: post-intervention(8th week)
Ultrasound parameters-resistance index(1)
(resistance index, RI)
Measured: pre-intervention(1st week)
Ultrasound parameters-resistance index(2)
(resistance index, RI)
Measured: during intervention(4th week)
Ultrasound parameters-resistance index(3)
(resistance index, RI)
Measured: post-intervention(8th week)
Ultrasound parameters-pulsatility index(1)
(pulsatility index, PI)
Measured: pre-intervention(1st week)
Ultrasound parameters-pulsatility index(2)
(pulsatility index, PI)
Measured: during intervention(4th week)
Ultrasound parameters-pulsatility index(3)
(pulsatility index, PI)
Measured: post-intervention(8th week)
Ultrasound parameters-diameter(1)
（diameter, D）
Measured: pre-intervention(1st week)
Ultrasound parameters-diameter(2)
（diameter, D）
Measured: during intervention(4th week)
Ultrasound parameters-diameter(3)
（diameter, D）
Measured: post-intervention(8th week)
Ultrasound parameters-area(1)
（area, A）
Measured: pre-intervention(1st week)
Ultrasound parameters-area(2)
（area, A）
Measured: during intervention(4th week)
Ultrasound parameters-area(3)
（area, A）
Measured: post-intervention(8th week)
walking speed-preferred(1)
Timed 10-Meter Walk Test (preferred)
Measured: pre-intervention(1st week)
walking speed-preferred(2)
Timed 10-Meter Walk Test (preferred)
Measured: during intervention(4th week)
walking speed-preferred(3)
Timed 10-Meter Walk Test (preferred)
Measured: post-intervention(8th week)
walking speed-fast(1)
Timed 10-Meter Walk Test (fast)
Measured: pre-intervention(1st week)
walking speed-fast(2)
Timed 10-Meter Walk Test (fast)
Measured: during intervention(4th week)
walking speed-fast(3)
Timed 10-Meter Walk Test (fast)
Measured: post-intervention(8th week)
Secondary outcomes (20)
body composition-height
height(cm)
Measured: pre-intervention(1st week)
body composition-weight
weight(kg)
Measured: pre-intervention(1st week)
body composition-waist circumference
waist circumference(cm)
Measured: pre-intervention(1st week)
vital sign-blood pressure(1)
blood pressure(mmHg)
Measured: pre-intervention(1st week)
vital sign-blood pressure(2)
blood pressure(mmHg)
Measured: during intervention(4th week)
vital sign-blood pressure(3)
blood pressure(mmHg)
Measured: post-intervention(8th week)
vital sign-heart rate(1)
heart rate(bpm)
Measured: pre-intervention(1st week)
vital sign-heart rate(2)
heart rate(bpm)
Measured: during intervention(4th week)
vital sign-heart rate(3)
heart rate(bpm)
Measured: post-intervention(8th week)
flexibility-chair sit and reach test (1)
chair sit and reach test (cm)
Measured: pre-intervention(1st week)
flexibility-chair sit and reach test (2)
chair sit and reach test (cm)
Measured: during intervention(4th week)
flexibility-chair sit and reach test (3)
chair sit and reach test (cm)
Measured: post-intervention(8th week)
grip strength
hand dynamometer
Measured: pre-intervention(1st week)
cognitive function
Montreal Cognitive Assessment.Minimum value is 0 and maximum value is 30, and higher scores mean a better outcome
Measured: pre-intervention(1st week)
frailty
SOF (Study of Osteoporotic Fractures). Minimum value is 0 and maximum value is 3, and higher scores mean a worse outcome
Measured: pre-intervention(1st week)
basic data
gender, age, education, living status, smoking, and exercise habits
Measured: pre-intervention(1st week)
ACSM-PAR-Q+
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.
Measured: pre-intervention(1st week)
IPAQ
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).
Measured: pre-intervention(1st week)
fitness
(Duke activity status index, DASI) Minimum value is 0 and maximum value is 58.2, and higher scores mean a better physical activity level.
Measured: pre-intervention(1st week)
adherence of exercise
usage records from the Line app
Measured: post-intervention(8th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StretchStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Wun Tsai, National Yang Ming Chiao Tung University
- Investigators
- Liang-Ying Lai, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871906
- Sponsor's protocol ID
- YM109100E
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults
- ClinicalTrials.gov ID
- NCT04871906
- Acronym / sponsor ID
- YM109100E
- Conditions
- Stretch
- Keywords
- stretching exercise, vascular function, blood flow, walking function, fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching exercises | Experimental | Other: stretching exercisesInterventions 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. |
| Control group | No intervention | –Maintain their daily activity level in the 8 weeks. We use the study desigh-''waiting list control'' in this group. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 20-85 years old
- Follow instructions
- Walk with/without assistive technology
Key exclusion criteria (4 listed)
- Unstable acute or chronic health conditions
- Peripheral vascular diseases
- Non-musculoskeletal problems that would limit stretching exercises
- Participate in other exercise programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stretching exercisesOur 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. | Other | Stretching exercises |
Primary outcome
vascular functions-Stiffness index(1)
Time frame: pre-intervention(1st week)
(Stiffness index, SI，unit：m/s)
vascular functions-Stiffness index(2)
Time frame: during intervention(4th week)
(Stiffness index, SI，unit：m/s)
vascular functions-Stiffness index(3)
Time frame: post-intervention(8th week)
(Stiffness index, SI，unit：m/s)
vascular functions-Reflective index(1)
Time frame: pre-intervention(1st week)
(Reflective index, RI，unit：％)
vascular functions-Reflective index(2)
Time frame: during intervention(4th week)
(Reflective index, RI，unit：％)
vascular functions-Reflective index(3)
Time frame: post-intervention(8th week)
(Reflective index, RI，unit：％)
vascular functions-Vascular age
Time frame: pre-intervention(1st week)
(Vascular age, VA，unit：year-old)
Ultrasound parameters-peak-systolic velocity(1)
Time frame: pre-intervention(1st week)
（peak-systolic velocity, PSV)
Ultrasound parameters-peak-systolic velocity(2)
Time frame: during intervention(4th week)
（peak-systolic velocity, PSV）
Ultrasound parameters-peak-systolic velocity(3)
Time frame: post-intervention(8th week)
（peak-systolic velocity, PSV）
Ultrasound parameters-end-diastolic velocity(1)
Time frame: pre-intervention(1st week)
（end-diastolic velocity, EDV）
Ultrasound parameters-end-diastolic velocity(2)
Time frame: during intervention(4th week)
（end-diastolic velocity, EDV）
Ultrasound parameters-end-diastolic velocity(3)
Time frame: post-intervention(8th week)
（end-diastolic velocity, EDV）
Ultrasound parameters-mean velocity(1)
Time frame: pre-intervention(1st week)
（mean velocity, mV）
Ultrasound parameters-mean velocity(2)
Time frame: during intervention(4th week)
（mean velocity, mV）
Ultrasound parameters-mean velocity(3)
Time frame: post-intervention(8th week)
（mean velocity, mV）
Ultrasound parameters-mean volume flow(1)
Time frame: pre-intervention(1st week)
(mean volume flow, vFl)
Ultrasound parameters-mean volume flow(2)
Time frame: during intervention(4th week)
(mean volume flow, vFl)
Ultrasound parameters-mean volume flow(3)
Time frame: post-intervention(8th week)
(mean volume flow, vFl)
Ultrasound parameters-resistance index(1)
Time frame: pre-intervention(1st week)
(resistance index, RI)
Ultrasound parameters-resistance index(2)
Time frame: during intervention(4th week)
(resistance index, RI)
Ultrasound parameters-resistance index(3)
Time frame: post-intervention(8th week)
(resistance index, RI)
Ultrasound parameters-pulsatility index(1)
Time frame: pre-intervention(1st week)
(pulsatility index, PI)
Ultrasound parameters-pulsatility index(2)
Time frame: during intervention(4th week)
(pulsatility index, PI)
Ultrasound parameters-pulsatility index(3)
Time frame: post-intervention(8th week)
(pulsatility index, PI)
Ultrasound parameters-diameter(1)
Time frame: pre-intervention(1st week)
（diameter, D）
Ultrasound parameters-diameter(2)
Time frame: during intervention(4th week)
（diameter, D）
Ultrasound parameters-diameter(3)
Time frame: post-intervention(8th week)
（diameter, D）
Ultrasound parameters-area(1)
Time frame: pre-intervention(1st week)
（area, A）
Ultrasound parameters-area(2)
Time frame: during intervention(4th week)
（area, A）
Ultrasound parameters-area(3)
Time frame: post-intervention(8th week)
（area, A）
walking speed-preferred(1)
Time frame: pre-intervention(1st week)
Timed 10-Meter Walk Test (preferred)
walking speed-preferred(2)
Time frame: during intervention(4th week)
Timed 10-Meter Walk Test (preferred)
walking speed-preferred(3)
Time frame: post-intervention(8th week)
Timed 10-Meter Walk Test (preferred)
walking speed-fast(1)
Time frame: pre-intervention(1st week)
Timed 10-Meter Walk Test (fast)
walking speed-fast(2)
Time frame: during intervention(4th week)
Timed 10-Meter Walk Test (fast)
walking speed-fast(3)
Time frame: post-intervention(8th week)
Timed 10-Meter Walk Test (fast)
20 secondary outcomes
body composition-height
Time frame: pre-intervention(1st week)
body composition-weight
Time frame: pre-intervention(1st week)
body composition-waist circumference
Time frame: pre-intervention(1st week)
vital sign-blood pressure(1)
Time frame: pre-intervention(1st week)
vital sign-blood pressure(2)
Time frame: during intervention(4th week)
vital sign-blood pressure(3)
Time frame: post-intervention(8th week)
vital sign-heart rate(1)
Time frame: pre-intervention(1st week)
vital sign-heart rate(2)
Time frame: during intervention(4th week)
vital sign-heart rate(3)
Time frame: post-intervention(8th week)
flexibility-chair sit and reach test (1)
Time frame: pre-intervention(1st week)
flexibility-chair sit and reach test (2)
Time frame: during intervention(4th week)
flexibility-chair sit and reach test (3)
Time frame: post-intervention(8th week)
grip strength
Time frame: pre-intervention(1st week)
cognitive function
Time frame: pre-intervention(1st week)
frailty
Time frame: pre-intervention(1st week)
basic data
Time frame: pre-intervention(1st week)
ACSM-PAR-Q+
Time frame: pre-intervention(1st week)
IPAQ
Time frame: pre-intervention(1st week)
fitness
Time frame: pre-intervention(1st week)
adherence of exercise
Time frame: post-intervention(8th week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Ying Lai principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stretching exercises in people with Stretch, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Wun Tsai, Ph.D (+886+2+28267939, tmwk@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular functions-Stiffness index(1) (time frame: pre-intervention(1st week)). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.