Regular Physical Exercise and Salt Diet on Coronary Arter... | NCT02076802

Studies
Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)

NCT02076802

Sponsor

General Hospital of Shenyang Military Region

Status

Unknown status

Last Update Posted

Mar 4, 2014Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Coronary Atherosclerosis
Cardiovascular Disease

Interventions

physical exercises

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jul 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Feb 25, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

xin Zhao, professor, General Hospital of Shenyang Military RegionPrincipal Investigator

Lead Sponsor

General Hospital of Shenyang Military RegionOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake.

The aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lifestyle counseling		physical exercises	Behavioral: physical exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical exercises	Behavioral		lifestyle counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fatal and nonfatal myocardial infarction, or coronary revascularization		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -

Exclusion Criteria:

with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Coronary atherosclerosis patients with prehypertension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Han Yaling	Contact	+86-24-23922184		hanyal@263.net
Zhao Xin	Contact	+86-24-28897266		455759500@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Shenyang Militaly Region	Recruiting	Shenyang	Liaoning	100016	China

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D002318	Cardiovascular Diseases
D058246	Prehypertension

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided