UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024689 |
|---|---|
| Receipt number | R000028407 |
| Scientific Title | A study about support methods to get an exercise habit for successful aging in community-dwelling older adults |
| Date of disclosure of the study information | 2016/11/02 |
| Last modified on | 2016/11/02 19:44:49 |
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Basic information
Public title
A study about support methods to get an exercise habit for successful aging in community-dwelling older adults
Acronym
Support methods to get an exercise habit in older adults
Scientific Title
A study about support methods to get an exercise habit for successful aging in community-dwelling older adults
Scientific Title:Acronym
Support methods to get an exercise habit in older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the long-term effects of exercise class for older married couples on exercise adherence and health-related outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise adherence
Key secondary outcomes
Physical fitness
Step counts
Marital relationships
Social support
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participate in exercise classes with spouse.
Frequency: 1 time/week, total 8 weeks
Program: strength exercise and walking
Interventions/Control_2
Participate in exercise classes by alone.
Frequency: 1 time/week, total 8 weeks
Program: strength exercise and walking
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) aged 65 years or older
(2) not restricted from exercising by a physician
(3) without exercise habits
(4) not being classified as "assistance required" or higher according to the Japanese long-term care insurance system.
Key exclusion criteria
(1) already engaged in regular exercise
(2) already participating in another clinical trial
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298532655
tanaka@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Osuka |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence of the Elderly
Zip code
Address
35-2, Sakae-cho, Itabashi, Tokyo
TEL
0339643241
Homepage URL
osuka@tmig.or.jp
Sponsor or person
Institute
Faculty of Health and Sport Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
The UNIVERS foundation
The Meiji Yasuda Life Foundation of
Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2016 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 03 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028407
