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

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 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


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

Value
https://center6.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