UMIN-CTR Clinical Trial

Basic information
Public title	Identification of effects related to improving physical activity by health education and fitness promotion in community dwelling older adults
Acronym	Identification of physical activity improvement effect by health education and fitness promotion
Scientific Title	Identification of effects related to improving physical activity by health education and fitness promotion in community dwelling older adults
Scientific Title:Acronym	Identification of physical activity improvement effect by health education and fitness promotion
Region	Japan

Condition
Condition	Healthy older adults
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Identification of physical activity improvement by health education and fitness promotion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of steps and physical activity time
Key secondary outcomes	Physical function (such as walking speed and balance)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Health education and fitness promotion for encouragement of physical activity, and mail-based behavioral change program
Interventions/Control_2	Health education and fitness promotion for encouragement of physical activity
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Up to 200 older adults participating to who used preventive health care services provided by the City Council of Social Welfare. 2. Among them, the consent of the document was obtained with the free will of the person who participated in this study.
Key exclusion criteria	1.With severe cardiac, pulmonary, diabetes, or kidney disease or musculoskeletal disorders 2.Having diagnosis of mental illness 3.With severe cognitive impairment
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tashiro Middle name Last name Hideyuki
Organization	Sapporo Medical University
Division name	First division of Physical Therapy
Zip code	0608556
Address	W17-S1, Cyuo-ku, Sapporo city, Hokkaido
TEL	011-611-2111
Email	tashirohideyuki@sapmed.ac.jp

Public contact
Name of contact person	1st name Tashiro Middle name Last name Hideyuki
Organization	Sapporo Medical University
Division name	First division of Physical Therapy
Zip code	0608556
Address	W17-S1, Cyuo-ku, Sapporo city, Hokkaido
TEL	0116112111
Homepage URL
Email	tashirohideyuki@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Sapporo Medical University
Address	W17-S1, Cyuo-ku, Sapporo city, Hokkaido
Tel	0116112111
Email	tetsuya.tamada@sapmed.ac.jp

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	2021 Year 04 Month 21 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	Terminated
Date of protocol fixation	2021 Year 04 Month 16 Day
Date of IRB	2021 Year 04 Month 20 Day
Anticipated trial start date	2021 Year 04 Month 21 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 21 Day
Last modified on	2022 Year 10 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050242