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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038251
Receipt No. R000043603
Scientific Title The effect of walking exercise with nordic pole on aerobic performance in patients with mild cerebral infanction
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/09

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Basic information
Public title The effect of walking exercise with nordic pole on aerobic performance in patients with mild cerebral infanction
Acronym The effect of walking exercise with nordic pole on aerobic performance in patients with mild cerebral infanction
Scientific Title The effect of walking exercise with nordic pole on aerobic performance in patients with mild cerebral infanction
Scientific Title:Acronym The effect of walking exercise with nordic pole on aerobic performance in patients with mild cerebral infanction
Region
Japan

Condition
Condition mild cerebral infarction
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To perform a conventional gait and gait using nordic pole patients with mild cerebral infarction who have and to evaluate and compare physical activity,cardiopulmonary exercise testing and physical function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Maximum intake oxygen during hospitalization and 1 month,3 month,and 6 months after discharge.
Key secondary outcomes Muscle strength,activity range,physical fitness,walking speed and physical activity.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Nordic poles at least 3 times a week at least 30 minutes at home.Continue until 6 months after discharge.
Interventions/Control_2 Walking at least 3 times a week at least 30 minutes at home.Continue until 6 months after discharge.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1:Initial cerebral infarction(including TIA)
2:Over 20 years old
3:Walking is independent within one week after hospitalization.
4:Walking is independent before hospitalization.
5:Can go to our hospital after leaving home
6:Consent to this study in writing.
Key exclusion criteria 1:Cannot wear physical activity meter continuously.
2:History of cardiopulmonary disorders and motor disorders that interfere with walking.
3:Administering drugs that affect the results of the cardiopulmonary exercise test.
4:Cognitive function declines and cannot follow instructions
5:Participating in other clinical studies within 28 day prior to registration.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name HIROYUKI
Middle name
Last name IWASAKI
Organization Saitama medical university international medical center
Division name rehabilitation center
Zip code 350-1298
Address 1397-1 Yamane.Hidaka City,Saitama Prefecture
TEL 0429844367
Email hiroiwasaki24@gmail.com

Public contact
Name of contact person
1st name HIROYUKI
Middle name
Last name IWASAKI
Organization Saitama medical university international medical center
Division name rehabilitation center
Zip code 350-1298
Address 1397-1 Yamane.Hidaka City,Saitama Prefecture
TEL 0429844367
Homepage URL
Email hiroiwasaki24@gmail.com

Sponsor
Institute Saitama medical university international medical center
Institute
Department

Funding Source
Organization None
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 Saitama medical university international medical center IRB
Address 1397-1 Yamane.Hidaka City,Saitama Prefecture
Tel 0429844523
Email chikens@saitama-med.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
2019 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 09 Day
Last modified on
2019 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043603

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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