UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015099 |
|---|---|
| Receipt number | R000017565 |
| Scientific Title | The effects of health promotion by mailing on exercise adherence after an exercise class ends |
| Date of disclosure of the study information | 2014/09/12 |
| Last modified on | 2016/09/13 12:09:11 |
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Basic information
Public title
The effects of health promotion by mailing on exercise adherence after an exercise class ends
Acronym
The study of health promotion by mailing
Scientific Title
The effects of health promotion by mailing on exercise adherence after an exercise class ends
Scientific Title:Acronym
The study of health promotion by mailing
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of health promotion by mailing on long-term exercise adherence and physical fitness after an exercise class ends.
Basic objectives2
Others
Basic objectives -Others
To examine the long-term effects of health promotion by mailing on muscle quality and activity after an exercise class ends.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Exercise adherence, physical fitness
2. Muscle quality, muscle activity
Key secondary outcomes
cognitive function, QoL, physical activity, mobility, falls, self efficacy, transtheoretical model, social support
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mailing group: 3-month exercise class and 9-month health promotion by mailing. A 90 min exercise class for once per week, includes lecture, warm-up, cool-down, strength training, and walking. Health promotion by mailing include exchange of exercise calendars and newsletters every month.
Interventions/Control_2
Non-mailing group: 3-month exercise class same as the mailing group.
Interventions/Control_3
Control group: No exercise class will be provided. At the end of the 3-month exercise class, a lecture on health and exercise class will be provided for one day. Applicants who were exercising more than the criteria of exercise, are to be asked to join the control group.
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
Aged between 65 years or older; not care-dependent or support-dependent on a Japanese long-term care insurance system; not restricted by a doctor from exercising; able to walking without walking aid; and without regular exercise habits.
Key exclusion criteria
Moderate-intensity endurance exercise >= 150 min/week and/or moderate-intensity resistance exercise >= 2 days/week; participating in another clinical trial.
Target sample size
140
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, 305-8577, Japan
TEL
+81-29-853-5600(8365)
tanaka@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jung Songee |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL
+81-29-853-5600(8365)
Homepage URL
matsui-tei@stat.taiiku.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
筑波大学総合研究棟D（茨城県）University of Tsukuba, Advanced research building D (Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 09 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017565
