This trial is active, not recruiting.

Conditions hypertension, dyslipidemia, diabetes, low back pain
Treatment physical activity
Sponsor National Institute of Health and Nutrition
Start date April 2006
End date April 2014
Trial size 1085 participants
Trial identifier NCT00926744, 21170901, qde402mm


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Physically inactive participants receiving both physical activity and dietary counseling
physical activity
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
(No Intervention)
Physically active participants receiving only dietary counseling
(No Intervention)
Physically inactive participants receiving only dietary counseling

Primary Outcomes

Objectively measured amount of physical activity
time frame: 10 years

Secondary Outcomes

Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
time frame: 5 years
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
time frame: 10 years
Incidence of musculoskeletal and joint pain
time frame: 1 year

Eligibility Criteria

Male or female participants from 30 years up to 64 years old.

Inclusion Criteria: - Males and females - Ages 30-64 years old Exclusion Criteria: - During treatment of any diseases - Two or more metabolic risk factors

Additional Information

Official title Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by National Institute of Health and Nutrition.