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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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)

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name