NCT01912690

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

July 29, 2013

Last Update Submit

September 20, 2015

Conditions

Ischemic Heart DiseaseCongestive Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Left ventrcular dyssynchrony

    Assessed by 2-D strain imaging

    3 months

Secondary Outcomes (1)

  • Autonomic function

    3 months

Study Arms (3)

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

aerobic trainingOTHER
aerobic training only
aerobic and strength trainingOTHER
Aerobic and strength training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Myocardial IschemiaHeart Failure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-08

Locations

IL(1)