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NCT00926744 Clinical Trial

Nutrition and Exercise Intervention Study

Hypertension Clinical Trial

— NEXIS  

Official title:
Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00926744
Other study ID # qde402mm
Secondary ID 21170901
Status Active, not recruiting
Phase N/A
First received June 23, 2009
Last updated March 27, 2017
Start date April 2006
Est. completion date March 2018

Study information
Verified date March 2017
Source National Institute of Health and Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present study was to clarify the effects of increase in physical activity on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the present study was that the physical activity to satisfy the Japanese guideline of Ministry of Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related disease.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1085
Est. completion date March 2018
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 64 Years
Eligibility Inclusion Criteria:

- Males and females

- Ages 30-64 years old

Exclusion Criteria:

- During treatment of any diseases

- Two or more metabolic risk factors

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• physical activity
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.

Locations
Country Name City State
Japan National Institute of Health and Nutrition Shinjuku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Health and Nutrition

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objectively measured amount of physical activity 10 years
Secondary Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) 5 years
Secondary Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) 10 years
Secondary Incidence of musculoskeletal and joint pain 1 year
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