UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038251 |
|---|---|
| Receipt number | 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 | 2023/04/07 11:05:01 |
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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 and 3 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
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
hiroiwasaki24@gmail.com
Sponsor or person
Institute
Saitama medical university international medical center
Institute
Department
Personal name
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
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
8
Results
Physical activity increased after discharge compared to admission , and maximal oxygen uptake was maintained from admission to 3 months after charge. Due to the small number of cases , there was no significant difference due to the use of the Nordic pole.
Results date posted
| 2023 | Year | 04 | Month | 07 | Day |
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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 03 | Day |
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
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043603
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