UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Acute effect of passive static stretching on arterial stiffness in sedentary elderly patients with an orthopedic disorder
Title of the study (Brief title)	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	Takeshi Morifuji
Organization	Osaka Kawasaki Rehabilitation University
Division name	Department of Rehabilitation
Address	Mizuma 158, Kaizuka City, Osaka 597-0104, Japan
TEL	072-446-6700
Email	morifujit@kawasakigakuen.ac.jp

Public contact
Name of contact person	Takeshi Morifuji
Organization	Osaka Kawasaki Rehabilitation University
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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