NCT00226733

Brief Summary

The purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. Secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 18, 2010

Status Verified

April 1, 2008

Enrollment Period

3 years

First QC Date

September 12, 2005

Last Update Submit

May 17, 2010

Conditions

Coronary Artery Bypass

Keywords

Coronary Artery Bypass (E04.928.220.520.220)Exercise Test [E01.370.370.380.250]Echocardiography [E01.370.370.380.220]Quality of Life [K01.752.400.750]

Outcome Measures

Primary Outcomes (1)

  • Oxygen Consumption

Secondary Outcomes (4)

  • Quality of life

  • Pulse

  • Blodverdier

  • Ekkokardiografiske parametre

Study Arms (2)

A

EXPERIMENTAL

Interval exercise training with high intensity

Behavioral: Exercise training

B

ACTIVE COMPARATOR

Exercise training with moderate intensity

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

Interval exercise training with high intensity five days per week for four weeks.

A

Eligibility Criteria

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

You may qualify if:

  • Coronary Artery Grafting (4-12 weeks ago)

You may not qualify if:

  • Not able to exercise on a treadmill
  • Left ventricle ejection fraction \< 30%
  • hemodynamic significant valve deficit (\> NYHA classification II)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7489, Norway

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stig A Slørdahl, Dr.med

    NTNU, Institutt for sirkulasjon og bildediagnostikk

    STUDY CHAIR

  • Trine T Moholdt, MS

    NTNU, Institutt for sirkulasjo og bildediagnostikk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 27, 2005

Study Start

March 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 18, 2010

Record last verified: 2008-04

Locations

NO(1)