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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000654
Receipt No. 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

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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
Email

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
Email zenymgt@yamanashi.ac.jp

Sponsor
Institute Department of Health Sciences, Interdisciplinary Graduate School of medicine and Engineering, University of Yamanashi
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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