Evaluation Rehabilitation on Glycometabolic State in Non-... | NCT00917930

Studies
Evaluation Rehabilitation on Glycometabolic State in Non-Diabetic Coronary Artery Disease (CAD) Patients

NCT00917930

Sponsor

IRCCS San Raffaele

Status

Completed

Last Update Posted

Jun 11, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

physical training

Countries

Not provided

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 10, 2009

First Posted Date

Jun 11, 2009Estimated

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

Jun 10, 2009

Last Update Posted Date

Jun 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
physical training			Behavioral: physical training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical training	Behavioral	intensive cardiac rehabilitation program	physical training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus

Secondary Outcomes

Measure	Description	Time Frame
to evaluate the potential beneficial effect of physical training on the glycometabolic state

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted to undergo a cycle of in-hospital cardiac rehabilitation
patients without a previous diagnosis of diabetes mellitus
patients able to start physical training within three days from admission
fasting blood glucose at admission < 126 mg/dl

Exclusion Criteria:

previous diagnosis of diabetes mellitus
acute coronary events or acute heart failure in the past three months
physical disabilities that contraindicate training

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

non diabetes patients with coronary artery disease

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D006331	Heart Diseases

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064797	Physical Conditioning, Human

Ancestor Terms

ID	Term
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided