UMIN-CTR Clinical Trial

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

patients with cerebrovascular accidents.

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tajima Fumihiro

Institute

Department

Personal name

Organization

Department of Rehabilitation Medicine. Wakayama Medical University, School of Medicine.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

08

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

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

Registered date

2011

Year

08

Month

15

Day

Last modified on

2016

Year

10

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007292