UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000654 |
|---|---|
| Receipt number | R000000790 |
| Scientific Title | A randomized controlled trial on the effects of twice-weekly combined aerobic and resistance training on cardiovascular risk factors in non-diabetic subjects |
| Date of disclosure of the study information | 2007/03/27 |
| Last modified on | 2007/11/19 10:16:48 |
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Basic information
Public title
A randomized controlled trial on the effects of twice-weekly combined aerobic and resistance training on cardiovascular risk factors in non-diabetic subjects
Acronym
Effects of exercise training on cardiovascular risk factors: randomized controlled trial
Scientific Title
A randomized controlled trial on the effects of twice-weekly combined aerobic and resistance training on cardiovascular risk factors in non-diabetic subjects
Scientific Title:Acronym
Effects of exercise training on cardiovascular risk factors: randomized controlled trial
Region
| Japan |
Condition
Condition
Japanese subjects of aged 30 to 70 years, HbA1c of 5.0-6.4%, and without medication for diabetes mellitus.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effect of twice-weekly exercise training on cardiovascular risk factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcome measures were HbA1c, plasma glucose and 1,5-AG. They were measured at baseline and 12 weeks. End point was variable change form baseline at 12 weeks.
Key secondary outcomes
Secondary outcome measures were plasma lipids, adiponectin, weight, and waist. They were measured at baseline and 12 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise interventions consisted of 12 weeks of combined aerobic and resistance exercise twice a week.
Interventions/Control_2
Control group was instructed about exercise.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients of medical check-up
aged 30 to 70 years;
hemoglobin A1c of 5.5 to 6.4%;
no current use of oral medication to treat diabetes mellitus.
Key exclusion criteria
diabetes mellitus;
cardiovascular disease;
hypertension (systolic blood pressure >160 mm Hg);
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zentaro Yamagata |
Organization
Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
Division name
Department of Health Sciences
Zip code
Address
1110, Shimokato, Thuo-shi, Yamanashi
TEL
055-273-9566
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zentaro Yamagata |
Organization
Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
Division name
Department of Health Sciences
Zip code
Address
1110, Shimokato, Thuo-shi, Yamanashi
TEL
055-273-9566
Homepage URL
zenymgt@yamanashi.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Interdisciplinary Graduate School of medicine and Engineering, University of Yamanashi
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
Japan
Other related organizations
Co-sponsor
Hosaka DM clinic
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
| 2007 | Year | 03 | Month | 27 | 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
| 2006 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 27 | Day |
Last modified on
| 2007 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000790
