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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mei-Wun Tsai, Ph.D
  • Phone Number: +886+2+28267939
  • Email: tmwk@ym.edu.tw

Study Locations

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age between 20-85 years old
  2. Follow instructions
  3. Walk with/without assistive technology

Exclusion Criteria:

  1. Unstable acute or chronic health conditions
  2. Peripheral vascular diseases
  3. Non-musculoskeletal problems that would limit stretching exercises
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: stretching exercises
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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