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Recruitment status Completed
Unique ID issued by UMIN UMIN000008304
Receipt No. R000009782
Scientific Title Effect of low-volume physical activity and vitamin E supplementation on oxidative modification of LDL in older adults
Date of disclosure of the study information 2012/06/29
Last modified on 2012/06/29

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Basic information
Public title Effect of low-volume physical activity and vitamin E supplementation on oxidative modification of LDL in older adults
Acronym Physical activity and vitamin E in older adults
Scientific Title Effect of low-volume physical activity and vitamin E supplementation on oxidative modification of LDL in older adults
Scientific Title:Acronym Physical activity and vitamin E in older adults
Region
Japan

Condition
Condition Cardiovascular disease risk markers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of 12 weeks of low-volume walking programme below the current recommended amount of exercise (< 150 minutes/week) and the daily recommended doses of vitamin E supplementation on oxidative stress, oxidative modification of LDL in older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Thiobarbituric acid reactive substances, oxidised LDL
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 30 - 45 minutes of walking on 2 days per week for 12 weeks
Interventions/Control_2 alfa-tocopherolintake and 30 - 45 minutes of walking on 2 days per week for 12 weeks
Interventions/Control_3 alfa-tocopherolintake
Interventions/Control_4 Maintaining usual lifestyle
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Participants were included over 60 years of age
Key exclusion criteria Participants using lipid- and/or glucose-lowering medications were excluded
Target sample size 38

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Nakamura
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima, Tokorozawa-city, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Sport Sciences, Waseda University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 29 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 Completed
Date of protocol fixation
2011 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 29 Day
Last modified on
2012 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009782


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