The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults

Stretch Clinical Trial

Official title:

The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871906
• Other study ID #: YM109100E
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2021
• Source: National Yang Ming University
• Contact: Mei-Wun Tsai, Ph.D
• Phone: +886+2+28267939
• Email: tmwk[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stretch

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular functions-Stiffness index(1)	(Stiffness index, SI,unit:m/s)	pre-intervention(1st week)
Primary	vascular functions-Stiffness index(2)	(Stiffness index, SI,unit:m/s)	during intervention(4th week)
Primary	vascular functions-Stiffness index(3)	(Stiffness index, SI,unit:m/s)	post-intervention(8th week)
Primary	vascular functions-Reflective index(1)	(Reflective index, RI,unit:%)	pre-intervention(1st week)
Primary	vascular functions-Reflective index(2)	(Reflective index, RI,unit:%)	during intervention(4th week)
Primary	vascular functions-Reflective index(3)	(Reflective index, RI,unit:%)	post-intervention(8th week)
Primary	vascular functions-Vascular age	(Vascular age, VA,unit:year-old)	pre-intervention(1st week)
Primary	Ultrasound parameters-peak-systolic velocity(1)	(peak-systolic velocity, PSV)	pre-intervention(1st week)
Primary	Ultrasound parameters-peak-systolic velocity(2)	(peak-systolic velocity, PSV)	during intervention(4th week)
Primary	Ultrasound parameters-peak-systolic velocity(3)	(peak-systolic velocity, PSV)	post-intervention(8th week)
Primary	Ultrasound parameters-end-diastolic velocity(1)	(end-diastolic velocity, EDV)	pre-intervention(1st week)
Primary	Ultrasound parameters-end-diastolic velocity(2)	(end-diastolic velocity, EDV)	during intervention(4th week)
Primary	Ultrasound parameters-end-diastolic velocity(3)	(end-diastolic velocity, EDV)	post-intervention(8th week)
Primary	Ultrasound parameters-mean velocity(1)	(mean velocity, mV)	pre-intervention(1st week)
Primary	Ultrasound parameters-mean velocity(2)	(mean velocity, mV)	during intervention(4th week)
Primary	Ultrasound parameters-mean velocity(3)	(mean velocity, mV)	post-intervention(8th week)
Primary	Ultrasound parameters-mean volume flow(1)	(mean volume flow, vFl)	pre-intervention(1st week)
Primary	Ultrasound parameters-mean volume flow(2)	(mean volume flow, vFl)	during intervention(4th week)
Primary	Ultrasound parameters-mean volume flow(3)	(mean volume flow, vFl)	post-intervention(8th week)
Primary	Ultrasound parameters-resistance index(1)	(resistance index, RI)	pre-intervention(1st week)
Primary	Ultrasound parameters-resistance index(2)	(resistance index, RI)	during intervention(4th week)
Primary	Ultrasound parameters-resistance index(3)	(resistance index, RI)	post-intervention(8th week)
Primary	Ultrasound parameters-pulsatility index(1)	(pulsatility index, PI)	pre-intervention(1st week)
Primary	Ultrasound parameters-pulsatility index(2)	(pulsatility index, PI)	during intervention(4th week)
Primary	Ultrasound parameters-pulsatility index(3)	(pulsatility index, PI)	post-intervention(8th week)
Primary	Ultrasound parameters-diameter(1)	(diameter, D)	pre-intervention(1st week)
Primary	Ultrasound parameters-diameter(2)	(diameter, D)	during intervention(4th week)
Primary	Ultrasound parameters-diameter(3)	(diameter, D)	post-intervention(8th week)
Primary	Ultrasound parameters-area(1)	(area, A)	pre-intervention(1st week)
Primary	Ultrasound parameters-area(2)	(area, A)	during intervention(4th week)
Primary	Ultrasound parameters-area(3)	(area, A)	post-intervention(8th week)
Primary	walking speed-preferred(1)	Timed 10-Meter Walk Test (preferred)	pre-intervention(1st week)
Primary	walking speed-preferred(2)	Timed 10-Meter Walk Test (preferred)	during intervention(4th week)
Primary	walking speed-preferred(3)	Timed 10-Meter Walk Test (preferred)	post-intervention(8th week)
Primary	walking speed-fast(1)	Timed 10-Meter Walk Test (fast)	pre-intervention(1st week)
Primary	walking speed-fast(2)	Timed 10-Meter Walk Test (fast)	during intervention(4th week)
Primary	walking speed-fast(3)	Timed 10-Meter Walk Test (fast)	post-intervention(8th week)
Secondary	body composition-height	height(cm)	pre-intervention(1st week)
Secondary	body composition-weight	weight(kg)	pre-intervention(1st week)
Secondary	body composition-waist circumference	waist circumference(cm)	pre-intervention(1st week)
Secondary	vital sign-blood pressure(1)	blood pressure(mmHg)	pre-intervention(1st week)
Secondary	vital sign-blood pressure(2)	blood pressure(mmHg)	during intervention(4th week)
Secondary	vital sign-blood pressure(3)	blood pressure(mmHg)	post-intervention(8th week)
Secondary	vital sign-heart rate(1)	heart rate(bpm)	pre-intervention(1st week)
Secondary	vital sign-heart rate(2)	heart rate(bpm)	during intervention(4th week)
Secondary	vital sign-heart rate(3)	heart rate(bpm)	post-intervention(8th week)
Secondary	flexibility-chair sit and reach test (1)	chair sit and reach test (cm)	pre-intervention(1st week)
Secondary	flexibility-chair sit and reach test (2)	chair sit and reach test (cm)	during intervention(4th week)
Secondary	flexibility-chair sit and reach test (3)	chair sit and reach test (cm)	post-intervention(8th week)
Secondary	grip strength	hand dynamometer	pre-intervention(1st week)
Secondary	cognitive function	Montreal Cognitive Assessment.Minimum value is 0 and maximum value is 30, and higher scores mean a better outcome	pre-intervention(1st week)
Secondary	frailty	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)
Secondary	basic data	gender, age, education, living status, smoking, and exercise habits	pre-intervention(1st week)
Secondary	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.	pre-intervention(1st week)
Secondary	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).	pre-intervention(1st week)
Secondary	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.	pre-intervention(1st week)
Secondary	adherence of exercise	usage records from the Line app	post-intervention(8th week)