Nutrition and Exercise Intervention Study (NEXIS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Motohiko Miyachi, National Institute of Health and Nutrition Identifier:
First received: June 23, 2009
Last updated: April 13, 2015
Last verified: April 2015
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.

Condition Intervention
Low Back Pain
Behavioral: physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People

Resource links provided by NLM:

Further study details as provided by National Institute of Health and Nutrition:

Primary Outcome Measures:
  • Objectively measured amount of physical activity [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Incidence of musculoskeletal and joint pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 1085
Study Start Date: April 2006
Estimated Study Completion Date: March 2018
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Physically inactive participants receiving both physical activity and dietary counseling
Behavioral: physical activity
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
No Intervention: Active
Physically active participants receiving only dietary counseling
No Intervention: Control
Physically inactive participants receiving only dietary counseling


Ages Eligible for Study:   30 Years to 64 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00926744

National Institute of Health and Nutrition
Shinjuku, Tokyo, Japan, 162-8636
Sponsors and Collaborators
National Institute of Health and Nutrition
  More Information

No publications provided

Responsible Party: Motohiko Miyachi, Chief, Department of Health Promotion and Exercise, National Institute of Health and Nutrition Identifier: NCT00926744     History of Changes
Other Study ID Numbers: qde402mm, 21170901
Study First Received: June 23, 2009
Last Updated: April 13, 2015
Health Authority: Japan: Foundation for Biomedical Research and Innovation

Keywords provided by National Institute of Health and Nutrition:
physical activity
cardiovascular diseases
musculo-skeletal problems

Additional relevant MeSH terms:
Cardiovascular Diseases
Low Back Pain
Back Pain
Lipid Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on November 25, 2015