UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026743 |
|---|---|
| Receipt number | R000030677 |
| Scientific Title | Effect of step exercise on aerobic fitness and progression of atherosclerosis in the elderly |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2017/03/28 18:52:47 |
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Basic information
Public title
Effect of step exercise on aerobic fitness and progression of atherosclerosis in the elderly
Acronym
Effect of step exercise on aerobic fitness and progression of atherosclerosis in the elderly
Scientific Title
Effect of step exercise on aerobic fitness and progression of atherosclerosis in the elderly
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masanori Ohta |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
Address
Kasumigaoka 1-1-1, Higashi-ku, Fukuoka
TEL
092-692-3187
m-ohta@fwu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Nishida |
Organization
Saga University
Division name
Faculty of Medicine
Zip code
Address
Nabeshima 5-1-1, Saga
TEL
0952-34-2287
Homepage URL
ynishida@cc.saga-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Aeribic fitness and arterial pulse wave velocity were significantly improved in the bench step exercise group.
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
Completed
Date of protocol fixation
| 2005 | Year | 02 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030677
