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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000047674
Receipt No. R000054358
Scientific Title Effects of stretching intervention on cold sensitivity and arterial stiffness
Date of disclosure of the study information 2022/05/07
Last modified on 2022/05/07

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Basic information
Public title Effects of stretching intervention on cold sensitivity and arterial stiffness
Acronym Effects of stretching intervention on cold sensitivity and arterial stiffness
Scientific Title Effects of stretching intervention on cold sensitivity and arterial stiffness
Scientific Title:Acronym Effects of stretching intervention on cold sensitivity and arterial stiffness
Region
Japan

Condition
Condition Middle-aged and older adults
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the effects of chronic stretching on cold sensitivity and arterial stiffness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of 4 weeks of stretching on cold sensitivity and arterial stiffness
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Stretching intervention
Interventions/Control_2 Sedentary control
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
55 years-old <=
Age-upper limit
88 years-old >=
Gender Female
Key inclusion criteria 1) Subjects who must ban or limit exercise therapy by the doctor
2) Subjects in this study were postmenopausal for at least 5 years
3) Nonsmoker
4) Subjects who do not have some therapies and/or medications
5) Subjects who are capable of making a decision by themselves, and provide written consent
Key exclusion criteria 1) Patients with obesity due to adrenal diseases
2) Patients with cardiovascular diseases
3) Patients with hepatic dysfunction
4) Patients with renal dysfunction (serum creatinine level: 3.0mg/dl or higher)
5) Pregnant or plans to become pregnant during the study period
6) Patients with limited exercise therapy
7) Others who judged inappropriate by the examining physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Motoyuki
Middle name
Last name Iemitsu
Organization Ritsumeikan University
Division name Faculty of Sport and Health Science
Zip code 525-8577
Address 1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL 0775994131
Email iemitsu@fc.ritsumei.ac.jp

Public contact
Name of contact person
1st name Motoyuki
Middle name
Last name Iemitsu
Organization Ritsumeikan University
Division name Faculty of Sport and Health Science
Zip code 525-8577
Address 1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL 0775994131
Homepage URL
Email iemitsu@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

Funding Source
Organization JSPS KAKENHI for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics committee of Ritsumeikan University
Address 1-1-1 Nojihigashi, Kusatsu, Shiga
Tel 0775613412
Email b-rinri@st.ritsumei.ac.jp

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

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 07 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 14
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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 12 Day
Date of IRB
2017 Year 07 Month 12 Day
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 07 Day
Last modified on
2022 Year 05 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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