UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008304 |
|---|---|
| Receipt number | 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 18:43:45 |
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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
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
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
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
Sponsor or person
Institute
Graduate School of Sport Sciences, Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009782
