UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of made to order exercise on exercise self efficacy and adherence among the general older adults
Title of the study (Brief title)	The impact of made to order exercise on exercise self efficacy
Region	Japan

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

Objectives
Narrative objectives1	to elucidate the efficacy of the made to order exercise on exercise self-efficacy and adherence compared to traditional exercise in the general older adults who has not exercise habits
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	exercise self-efficacy score at 12-months after intervention
Key secondary outcomes	1)exercise self-efficacy score at 3 to 9-months after intervention 2)adherence 3)locomotive syndrome 4)incidence of falling 5) physical function; gait speed, gait acceleration, grip power and pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	prescribe the made to order exercise using automatic exercise prescription on PC software
Interventions/Control_2	prescribe the traditional exercise by simple pamphlet
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)who aged 65 years old to 74 years when they were imformed consent 2) who are not exercise habits 3) who are gait imdependently 4) who can be assess the physical performance tests 5) who are imformed consent
Key exclusion criteria	1) who are locomotive syndrome 2) who are sarcopenia 3)who had severe comobities 4)who had a fragility fracture 5)who had a surgery for arthoroplasty 6)who had a nursing care insurance since one year 7) who had a health problems since one year 8) resarchers desided the subjects are not appropriate in this study
Target sample size	60

Research contact person
Name of lead principal investigator	Hiromi Matsumoto
Organization	Tottori University Hospital
Division name	Rehabilitation Division
Address	Nishicho 36-1, Yonago, Tottori
TEL	0859-38-6862
Email	h.matsumoto@med.tottori-u.ac.jp

Public contact
Name of contact person	Takashi Wada
Organization	Tottori University Hospital
Division name	Rehabilitation Division
Address	Nishicho 36-1, Yonago, Tottori
TEL	0859-38-6862
Homepage URL
Email	t.wada@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University Hospital
Institute
Department

Funding Source
Organization	Tottori University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 17 Day
Anticipated trial start date	2017 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 03 Day
Last modified on	2017 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031207