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Nutrition and Exercise Intervention Study

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00926744
Acronym
NEXIS
Enrollment
1085
Registered
2009-06-24
Start date
2006-04-30
Completion date
2018-03-31
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Dyslipidemia, Hypertension, Low Back Pain

Keywords

physical activity, nutrition, cardiovascular diseases, musculo-skeletal problems

Brief 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.

Interventions

BEHAVIORALphysical activity

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

Sponsors

National Institute of Health and Nutrition
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Males and females * Ages 30-64 years old

Exclusion criteria

* During treatment of any diseases * Two or more metabolic risk factors

Design outcomes

Primary

MeasureTime frame
Objectively measured amount of physical activity10 years

Secondary

MeasureTime frame
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)10 years
Incidence of musculoskeletal and joint pain1 year
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)5 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026