The Influence of Different Training Regimens on Electrica... | NCT01912690

Studies
The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction

NCT01912690

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Sep 22, 2015Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Ischemic Heart Disease
Congestive Heart Failure

Interventions

aerobic training
aerobic and strength training

Countries

Israel

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

Aug 2015

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

Jul 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Not provided

First Submitted Date

Jul 29, 2013

First Submission Date that Met QC Criteria

Jul 30, 2013

First Posted Date

Jul 31, 2013Estimated

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

Sep 20, 2015

Last Update Posted Date

Sep 22, 2015Estimated

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 hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
standard of care	Placebo Comparator
aerobic training only	Active Comparator	Other: aerobic training
Aerobic and strength training	Active Comparator	Other: aerobic and strength training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aerobic training	Other		aerobic training only
aerobic and strength training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventrcular dyssynchrony	Assessed by 2-D strain imaging	3 months

Secondary Outcomes

Measure	Description	Time Frame
Autonomic function	Assessed by Holter	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

s/p acute myocardial infarction 14-30 days
ability to perform exercise

Exclusion Criteria:

unstable angina
chronic atrial fibrillation
severely reduced LV function
NYHA 4
severe valvular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah University Medical Center		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided