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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006171
Receipt No. R000007292
Scientific Title Plasma interleukin-6 during walking exercise in patients with cerebrovascular accidents.
Date of disclosure of the study information 2011/08/15
Last modified on 2016/10/25

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Basic information
Public title Plasma interleukin-6 during walking exercise in patients with cerebrovascular accidents.
Acronym IL-6 during walking exercise in patients with CVA.
Scientific Title Plasma interleukin-6 during walking exercise in patients with cerebrovascular accidents.
Scientific Title:Acronym IL-6 during walking exercise in patients with CVA.
Region
Japan

Condition
Condition patients with cerebrovascular accidents.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Walking is one of well recommended exercise in stroke survivors.
Recently, Pedersen et al. published that skeletal muscle was identified as an endocrine organ excreting cytokines and other peptides.
Myokines may be involved in mediating the health beneficial effects of exercise and play important roles in the protection against diseases associated with cardiovascular diseases, type 2 diabetes, and cancer.
Moreover, more specific knowledge about the mechanisms whereby exercise alters the function and metabolism in adipose tissue, liver, and brain, is required to prescribe exercise as therapy.
The IL-6 response is sensitive to the exercise intensity and duration and contracting skeletal muscle per se is an important source of IL-6 found in the plasma.
Therefore, we doubt that exercise intensity of walking during less than 1h would be not enough to increase IL-6 in healthy subjects, because at least 1h running could increase IL-6 in healthy subjects.
However, walking exercise per se generally involves extra energy expenditure in stroke survivor with IH compared with able bodied healthy subjects, because IH should use ankle-foot orthosis and canes during walking.

Basic objectives2 Others
Basic objectives -Others Rehabilitation medicine
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate,Blood pressure,Borg's scale,Interleukin-6,Interleukin-10,Brain-derived neurotrophic factor,Complete Blood Cout,adrenaline,Norepinephrine,Dopamine,Cortisol,Brain Natriuretic Peptide, Tumor Necrosis Factor-a,C-Reactive Protein,Myoglobin,Creatine Kinase,Glucose
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male
Key inclusion criteria They were all subject able to walk independently, using an ankle-foot orthosis and cane.
Key exclusion criteria symptoms of unstable cardiac disease:
(1) medical instability (ie, uncontrolled hypertension, arrhythmia, or unstable cardiovascular status, symptom-limiting peripheral vascular disease, recent pulmonary embolism), (2) significant musculoskeletal problems from other than stroke.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohko Hiroshi
Organization Kitade Hospital
Division name (4) Department of Rehabilitation
Zip code
Address Gobo-shi, Wakayama, Japan.
TEL 0738-24-3007
Email ohko-h@seijoh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ohko Hiroshi
Organization Kitade Hospital
Division name Department of Rehabilitation
Zip code
Address Wakayama, Japan
TEL 0738-24-3007
Homepage URL
Email ohko-h@seijoh-u.ac.jp

Sponsor
Institute Tajima Fumihiro
Institute
Department

Funding Source
Organization Department of Rehabilitation Medicine. Wakayama Medical University, School of Medicine.
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

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 15 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 60 walks of the cerebrovascular person with a disability raise blood IL-6 levels.
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
2011 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The purpose of the present study was to investigate changes of IL-6 during walking exercise with IH.

Management information
Registered date
2011 Year 08 Month 15 Day
Last modified on
2016 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007292

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/10/25 歩行データ(60min).xlsx


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