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Nutrition and Exercise Intervention Study (NEXIS)

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ClinicalTrials.gov Identifier: NCT00926744
Recruitment Status : Active, not recruiting
First Posted : June 24, 2009
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Dyslipidemia Diabetes Low Back Pain Behavioral: physical activity

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1085 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Actual Study Start Date : April 2006
Primary Completion Date : April 2014
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Objectively measured amount of physical activity [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc) [ Time Frame: 5 years ]
  2. Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes) [ Time Frame: 10 years ]
  3. Incidence of musculoskeletal and joint pain [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926744

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

Responsible Party: Motohiko Miyachi, Chief, Department of Health Promotion and Exercise, National Institute of Health and Nutrition
ClinicalTrials.gov Identifier: NCT00926744     History of Changes
Other Study ID Numbers: qde402mm
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases