Nutrition and Exercise Intervention Study
NEXIS
Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People
2 other identifiers
interventional
1,085
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Apr 2006
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 29, 2017
March 1, 2017
8 years
June 23, 2009
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objectively measured amount of physical activity
10 years
Secondary Outcomes (3)
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
5 years
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
10 years
Incidence of musculoskeletal and joint pain
1 year
Study Arms (3)
Intervention
EXPERIMENTALPhysically inactive participants receiving both physical activity and dietary counseling
Active
NO INTERVENTIONPhysically active participants receiving only dietary counseling
Control
NO INTERVENTIONPhysically inactive participants receiving only dietary counseling
Interventions
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
Eligibility Criteria
You may qualify if:
- Males and females
- Ages 30-64 years old
You may not qualify if:
- During treatment of any diseases
- Two or more metabolic risk factors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Health and Nutrition
Shinjuku, Tokyo, 162-8636, Japan
Related Publications (1)
Tripette J, Gando Y, Murakami H, Kawakami R, Tanisawa K, Ohno H, Konishi K, Tanimoto M, Tanaka N, Kawano H, Yamamoto K, Morishita A, Iemitsu M, Sanada K, Miyatake N, Miyachi M. Effect of a 1-year intervention comprising brief counselling sessions and low-dose physical activity recommendations in Japanese adults, and retention of the effect at 2 years: a randomized trial. BMC Sports Sci Med Rehabil. 2021 Oct 25;13(1):133. doi: 10.1186/s13102-021-00360-7.
PMID: 34696811DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Department of Health Promotion and Exercise
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 24, 2009
Study Start
April 1, 2006
Primary Completion
April 1, 2014
Study Completion
March 1, 2018
Last Updated
March 29, 2017
Record last verified: 2017-03