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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015099
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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)
Email 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
Email matsui-tei@stat.taiiku.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017565


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