NCT04871906

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

April 26, 2021

Last Update Submit

April 29, 2021

Conditions

Keywords

stretching exercisevascular functionblood flowwalking functionfitness

Outcome Measures

Primary Outcomes (37)

  • vascular functions-Stiffness index(1)

    (Stiffness index, SI,unit:m/s)

    pre-intervention(1st week)

  • vascular functions-Stiffness index(2)

    (Stiffness index, SI,unit:m/s)

    during intervention(4th week)

  • vascular functions-Stiffness index(3)

    (Stiffness index, SI,unit:m/s)

    post-intervention(8th week)

  • vascular functions-Reflective index(1)

    (Reflective index, RI,unit:%)

    pre-intervention(1st week)

  • vascular functions-Reflective index(2)

    (Reflective index, RI,unit:%)

    during intervention(4th week)

  • vascular functions-Reflective index(3)

    (Reflective index, RI,unit:%)

    post-intervention(8th week)

  • vascular functions-Vascular age

    (Vascular age, VA,unit:year-old)

    pre-intervention(1st week)

  • Ultrasound parameters-peak-systolic velocity(1)

    (peak-systolic velocity, PSV)

    pre-intervention(1st week)

  • Ultrasound parameters-peak-systolic velocity(2)

    (peak-systolic velocity, PSV)

    during intervention(4th week)

  • Ultrasound parameters-peak-systolic velocity(3)

    (peak-systolic velocity, PSV)

    post-intervention(8th week)

  • Ultrasound parameters-end-diastolic velocity(1)

    (end-diastolic velocity, EDV)

    pre-intervention(1st week)

  • Ultrasound parameters-end-diastolic velocity(2)

    (end-diastolic velocity, EDV)

    during intervention(4th week)

  • Ultrasound parameters-end-diastolic velocity(3)

    (end-diastolic velocity, EDV)

    post-intervention(8th week)

  • Ultrasound parameters-mean velocity(1)

    (mean velocity, mV)

    pre-intervention(1st week)

  • Ultrasound parameters-mean velocity(2)

    (mean velocity, mV)

    during intervention(4th week)

  • Ultrasound parameters-mean velocity(3)

    (mean velocity, mV)

    post-intervention(8th week)

  • Ultrasound parameters-mean volume flow(1)

    (mean volume flow, vFl)

    pre-intervention(1st week)

  • Ultrasound parameters-mean volume flow(2)

    (mean volume flow, vFl)

    during intervention(4th week)

  • Ultrasound parameters-mean volume flow(3)

    (mean volume flow, vFl)

    post-intervention(8th week)

  • Ultrasound parameters-resistance index(1)

    (resistance index, RI)

    pre-intervention(1st week)

  • Ultrasound parameters-resistance index(2)

    (resistance index, RI)

    during intervention(4th week)

  • Ultrasound parameters-resistance index(3)

    (resistance index, RI)

    post-intervention(8th week)

  • Ultrasound parameters-pulsatility index(1)

    (pulsatility index, PI)

    pre-intervention(1st week)

  • Ultrasound parameters-pulsatility index(2)

    (pulsatility index, PI)

    during intervention(4th week)

  • Ultrasound parameters-pulsatility index(3)

    (pulsatility index, PI)

    post-intervention(8th week)

  • Ultrasound parameters-diameter(1)

    (diameter, D)

    pre-intervention(1st week)

  • Ultrasound parameters-diameter(2)

    (diameter, D)

    during intervention(4th week)

  • Ultrasound parameters-diameter(3)

    (diameter, D)

    post-intervention(8th week)

  • Ultrasound parameters-area(1)

    (area, A)

    pre-intervention(1st week)

  • Ultrasound parameters-area(2)

    (area, A)

    during intervention(4th week)

  • Ultrasound parameters-area(3)

    (area, A)

    post-intervention(8th week)

  • walking speed-preferred(1)

    Timed 10-Meter Walk Test (preferred)

    pre-intervention(1st week)

  • walking speed-preferred(2)

    Timed 10-Meter Walk Test (preferred)

    during intervention(4th week)

  • walking speed-preferred(3)

    Timed 10-Meter Walk Test (preferred)

    post-intervention(8th week)

  • walking speed-fast(1)

    Timed 10-Meter Walk Test (fast)

    pre-intervention(1st week)

  • walking speed-fast(2)

    Timed 10-Meter Walk Test (fast)

    during intervention(4th week)

  • walking speed-fast(3)

    Timed 10-Meter Walk Test (fast)

    post-intervention(8th week)

Secondary Outcomes (20)

  • body composition-height

    pre-intervention(1st week)

  • body composition-weight

    pre-intervention(1st week)

  • body composition-waist circumference

    pre-intervention(1st week)

  • vital sign-blood pressure(1)

    pre-intervention(1st week)

  • vital sign-blood pressure(2)

    during intervention(4th week)

  • +15 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Stretching exercises

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 20-85 years old
  • Follow instructions
  • Walk with/without assistive technology

You may not qualify if:

  • Unstable acute or chronic health conditions
  • Peripheral vascular diseases
  • Non-musculoskeletal problems that would limit stretching exercises
  • Participate in other exercise programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Liang-Ying Lai

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Wun Tsai, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 4, 2021

Study Start

September 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 4, 2021

Record last verified: 2021-04

Locations