UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021265 |
|---|---|
| Receipt number | R000024530 |
| Scientific Title | The effectiveness of walking, stretching, and resistance training with nordic walking poles |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2019/09/04 10:06:15 |
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Basic information
Public title
The effectiveness of walking, stretching, and resistance training with nordic walking poles
Acronym
The effectiveness of exercise with nordic walking poles
Scientific Title
The effectiveness of walking, stretching, and resistance training with nordic walking poles
Scientific Title:Acronym
The effectiveness of exercise with nordic walking poles
Region
| Japan |
Condition
Condition
metabolic syndrome, sarcopenia
Classification by specialty
| Endocrinology and Metabolism | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of exercise with nordic walking poles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
balance function at 3-6 months after intervention
Key secondary outcomes
flexibility, muscle strength of lower extremities, walking ability, functional mobility, aerobic capacity at 3-6 months after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The subjects of intervention group are going to receive exercise instruction of walking, stretching, and/or resistance training with nordic walking poles from certified person 3 or 4 times a month for 3 to 6 months.
The subjects are also going to perform voluntary training at home during the period.
Interventions/Control_2
The subjects of control group are going to receive normal exercise instruction of walking, stretching, and/or resistance training without nordic walking poles 3 or 4 times a month for 3 to 6 months.
The subjects are also going to perform voluntary training at home during the period.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male or female of more than 20 years who has never performed exercise with nordic walking poles before.
Key exclusion criteria
Subjects with known illnesses, injuries, or mental disorders who can not perform exercise with nordic walking poles safely.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Matsumoto |
Organization
Keio University School of Medicine
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
+81-3-3353-1211
m-hideo@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Tabata |
Organization
Keio University School of Medicine
Division name
Institute for Integrated Sports Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
+81-3-3353-1211
Homepage URL
sky_walker_590718@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Institute for Integrated Sports Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
(NPO corporation) Japan Nordic Walking School
Name of secondary funder(s)
(NPO corporation) Healthy Communication Network
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024530
