UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029651 |
|---|---|
| Receipt number | R000033882 |
| Scientific Title | The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial. |
| Date of disclosure of the study information | 2017/10/22 |
| Last modified on | 2018/08/21 19:22:18 |
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Basic information
Public title
The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial.
Acronym
The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial.
Scientific Title
The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial.
Scientific Title:Acronym
The effectiveness of Nordic walking on willingness to volunteer work, physical or mental function among older adults: Randomized controlled trial.
Region
| Japan |
Condition
Condition
None.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of Nordic work on willingness to
volunteer, physical or cognitive function among the older adults who engage in cultural volunteer work.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Willingness to volunteer work
[Physical function]
Hand grip, walking speed, balance ability, time up and go test
[Cognitive function]
Mini-Mental State Examination, Japanese version of Montreal Cognitive Assessment, Trail-Making-Test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-monitoring of physical activity
Health education
Nordic walking
Interventions/Control_2
Self-monitoring of physical activity
Health education
Interventions/Control_3
Health education
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Engaging in cultural volunteer group.
2. Those who have anxious of walking.
Key exclusion criteria
1. individuals who have neuromuscular disease.
2. those who have heart, kidney, or liver dysfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Fujiwara |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Social Participation and Community Health Research Team
Zip code
Address
35-2 Sakae-cho, Itabashi, Tokyo 173-0015, Japan
TEL
03-3964-3241
fujiwayo@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Nemoto |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Social Participation and Community Health Research Team
Zip code
Address
35-2 Sakae-cho, Itabashi, Tokyo 173-0015, Japan
TEL
03-3964-3241
Homepage URL
nemoto@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Unicharm Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2017 | Year | 10 | Month | 22 | 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
| 2017 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2018 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033882
