NCT00218985

Brief Summary

The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 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

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

11.9 years

First QC Date

September 20, 2005

Last Update Submit

February 16, 2018

Conditions

AnginaCoronary Artery Disease

Keywords

Aerobic capacityExercise trainingCABGEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular function and quality of life

    Before and up to 1 year after intervention

Secondary Outcomes (2)

  • Structure and function of cardiomyocytes

    After the intervention period

  • Cardiomyocyte structure and function

    after the intervention period

Study Arms (2)

exercise training

EXPERIMENTAL
Behavioral: Exercise training

physician's advice

NO INTERVENTION

patients follow their physician's advice in regard to physical activity.

Interventions

Exercise trainingBEHAVIORAL

Intensity controlled exercise training before the scheduled bypass surgery

exercise training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for CABG both with and without heart failure

You may not qualify if:

  • Unstable angina
  • Unable to walk on a treadmill (except those with heart failure who only will serve as a reference group)
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7489, Norway

Location

Related Publications (1)

  • Smenes BT, Baekkerud FH, Slagsvold KH, Hassel E, Wohlwend M, Pinho M, Hoydal M, Wisloff U, Rognmo O, Wahba A. Acute exercise is not cardioprotective and may induce apoptotic signalling in heart surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2018 Jul 1;27(1):95-101. doi: 10.1093/icvts/ivx439.

    PMID: 29447379RESULT

MeSH Terms

Conditions

Angina PectorisCoronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ulrik Wisloff, Ph.D

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 20, 2018

Record last verified: 2018-02

Locations

NO(1)