HypertensionNEXISNCT00926744
Nutrition and Exercise Intervention Study
A study testing physical activity in people with Hypertension and Dyslipidemia, run by National Institute of Health and Nutrition at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Dyslipidemia, Diabetes
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,085 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2006to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- Ages 30-64 years old
Who cannot join
- During treatment of any diseases
- Two or more metabolic risk factors
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Institute of Health and Nutrition
Shinjuku, Tokyo, 162-8636
About this study
Official title: Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People
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.
- Conditions
- Hypertension, Dyslipidemia, Diabetes, Low Back Pain
- Being tested
- physical activity
- Keywords
- physical activity, nutrition, cardiovascular diseases, musculo-skeletal problems
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus, Low Back Pain, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
The targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Physically inactive participants receiving both physical activity and dietary counseling Receives: Behavioral: physical activity |
| Active | No intervention | Physically active participants receiving only dietary counseling |
| Control | No intervention | Physically inactive participants receiving only dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively measured amount of physical activity
Measured: 10 years
Secondary outcomes (3)
Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
Measured: 5 years
Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
Measured: 10 years
Incidence of musculoskeletal and joint pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startApr 2006
- Primary completionApr 2014
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Health and Nutrition
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Motohiko Miyachi, National Institute of Health and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926744
- Sponsor's protocol ID
- qde402mm
- Other IDs
- 21170901
- Acronym
- NEXIS
- Status last verified
- Mar 2017
- First submitted
- 23 Jun 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34696811
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People
- ClinicalTrials.gov ID
- NCT00926744
- Acronym / sponsor ID
- NEXIS / qde402mm
- Conditions
- Hypertension, Dyslipidemia, Diabetes, Low Back Pain
- Keywords
- physical activity, nutrition, cardiovascular diseases, musculo-skeletal problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- National Institute of Health and NutritionOther government
- Study start
- Apr 2006 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- Mar 2018 (estimated)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: physical activityPhysically inactive participants receiving both physical activity and dietary counseling |
| Active | No intervention | –Physically active participants receiving only dietary counseling |
| Control | No intervention | –Physically inactive participants receiving only dietary counseling |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and females
- Ages 30-64 years old
Key exclusion criteria (2 listed)
- During treatment of any diseases
- Two or more metabolic risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activityThe targets of amount of physical activity are 3.3METs•h/day (MVPA) and 10,000 step counts/day. | Behavioural | Intervention |
Primary outcome
Objectively measured amount of physical activity
Time frame: 10 years
3 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 34696811Tripette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Hypertension and Dyslipidemia, run by National Institute of Health and Nutrition at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively measured amount of physical activity (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00926744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.