UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of step exercise on aerobic fitness and progression of atherosclerosis in the elderly
Title of the study (Brief title)	Effect of step exercise on aerobic fitness and progression of atherosclerosis in the elderly
Region	Japan

Condition
Condition	atherosclerosis
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of 12-week step exercise on fitness and indices of atherosclerosis in the elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	arterial pulse wave velocity
Key secondary outcomes	aerobic fitness, atherosclerosis related factors (2-thiobarbituric acid reactive substances [TBARS], superoxide dismutase 3 extracellular [EC-SOD], Nitric oxide [NO] synthase)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	The subjects in the exercise group were instructed to perform home-based exercises using a bench step, with a goal of performing 140 min/week at home for 12 weeks.
Interventions/Control_2	The subjects in the control group were instructed to not change (and to simply maintain) their normal lifestyle.
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	55 years-old <=
Age-upper limit	85 years-old >=
Gender	Female
Key inclusion criteria	Being post-menopausal older females aged equal to or younger than 85 years
Key exclusion criteria	Any medical conditions that contraindicated exercise, such as cardiovascular disease and orthopedic disease
Target sample size	60

Research contact person
Name of lead principal investigator	Masanori Ohta
Organization	Fukuoka Women's University
Division name	International College of Arts and Sciences
Address	Kasumigaoka 1-1-1, Higashi-ku, Fukuoka
TEL	092-692-3187
Email	m-ohta@fwu.ac.jp

Public contact
Name of contact person	Yuichiro Nishida
Organization	Saga University
Division name	Faculty of Medicine
Address	Nabeshima 5-1-1, Saga
TEL	0952-34-2287
Homepage URL
Email	ynishida@cc.saga-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization	Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	産業医科大学

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 02 Month 17 Day
Anticipated trial start date	2005 Year 04 Month 01 Day
Last follow-up date	2007 Year 03 Month 31 Day
Date of closure to data entry	2008 Year 03 Month 31 Day
Date trial data considered complete	2008 Year 03 Month 31 Day
Date analysis concluded	2008 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Aeribic fitness and arterial pulse wave velocity were significantly improved in the bench step exercise group.
Other related information

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2017 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030677