UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034293 |
|---|---|
| Receipt number | 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 20:24:26 |
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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
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
morifujit@kawasakigakuen.ac.jp
Sponsor or person
Institute
Osaka Kawasaki Rehabilitation University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039097
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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