UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034293
Receipt No. R000039097
Scientific Title Acute effect of passive static stretching on arterial stiffness in sedentary elderly patients with an orthopedic disorder
Date of disclosure of the study information 2018/09/27
Last modified on 2018/10/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Acute effect of passive static stretching on arterial stiffness in sedentary elderly patients with an orthopedic disorder
Acronym Acute effect of passive static stretching on arterial stiffness in sedentary elderly patients with an orthopedic disorder
Scientific Title Acute effect of passive static stretching on arterial stiffness in sedentary elderly patients with an orthopedic disorder
Scientific Title:Acronym Acute effect of passive static stretching on arterial stiffness in sedentary elderly patients with an orthopedic disorder
Region
Japan

Condition
Condition arterial stiffness
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this clinical trial was to examine the acute effect of stretching on the arterial stiffness of sedentary elderly patients with an orthopedic disorder.Furthermore, this trial investigated the relationship between arterial stiffness and major physical function indicators in these patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardio-ankle vascular index (CAVI) was measured by a noninvasive vascular screening system before and after stretching.
Key secondary outcomes Ankle-brachial index (ABI), blood pressure, and pulse rate were measured by a noninvasive vascular screening system before and after stretching.
Body composition,handgrip strength,sit-and-reach distance were measured.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The patients were subjected to a single round of passive static stretching of the neck, trunk, and extremities by a physiotherapist. All stretches were held for 30 sec at the point of maximal range of motion for 3 repetitions. The strength of the stretching was set so that the subject feels the stretch but not pain.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria >= 65 years
having an orthopedic disorder
no history of significant exercise (not exercising >=3 Mets, >=30 minutes, >=twice a week)
Key exclusion criteria having diagnosis or history of cardiac disease, peripheral vascular disease, stroke sequelae, chronic renal failure, and mental disorder
having bone fracture
having pain that would limit stretching exercise
difficulty of walking outdoor independently
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Morifuji
Organization Osaka Kawasaki Rehabilitation University
Division name Department of Rehabilitation
Zip code
Address Mizuma 158, Kaizuka City, Osaka 597-0104, Japan
TEL 072-446-6700
Email morifujit@kawasakigakuen.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Morifuji
Organization Osaka Kawasaki Rehabilitation University
Division name Department of Rehabilitation
Zip code
Address Mizuma 158, Kaizuka City, Osaka 597-0104, Japan
TEL 072-446-6700
Homepage URL
Email morifujit@kawasakigakuen.ac.jp

Sponsor
Institute Osaka Kawasaki Rehabilitation University
Institute
Department

Funding Source
Organization Osaka Kawasaki Rehabilitation University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人健彰会 緑かねこ整形外科 (大阪市)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 10 Day
Last follow-up date
2018 Year 03 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 02 Day
Date trial data considered complete
2018 Year 07 Month 19 Day
Date analysis concluded
2018 Year 07 Month 20 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 27 Day
Last modified on
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.