UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of health promotion by mailing on exercise adherence after an exercise class ends
Title of the study (Brief title)	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	Kiyoji Tanaka
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
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	Jung Songee
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
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

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017565