NCT00363922

Brief Summary

The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Timeline
Completed

Started Sep 2006

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

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

August 10, 2006

Last Update Submit

September 28, 2015

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass [E04.100.376.719.332]

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen consumption

    At baseline and after 6 months

Secondary Outcomes (3)

  • Blood analyses (different markers for cardiovascular risk and endothelian function)

    At baseline and after 6 months

  • Endothelian function (flow mediated dilatation)

    At baseline and after 6 months

  • Quality of life (SF36 and MacNew)

    At baseline and after 6 months

Study Arms (2)

1

EXPERIMENTAL

Rehabilitation in institution

Behavioral: Rehabilitation in institution

2

ACTIVE COMPARATOR

Rehabilitation at home

Behavioral: Rehabilitation at homeBehavioral: Out-patient rehabilitation at the hospital

Interventions

Rehabilitation in institutionBEHAVIORAL

Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.

1
Rehabilitation at homeBEHAVIORAL

Subjects get a written prescription of exercise training, diet, etc. to follow at home.

2
Out-patient rehabilitation at the hospitalBEHAVIORAL

This intervention was removed. We never got time to randomize subjects into this category. We had planned to randomize patients from one hospital to either Rehabilitation in institution (rehab center) or rehabilitation at the hospital (out patient). And also patients from another hospital to either rehabilitation in institution (rehab centre) or rehabilitation at home. We have only managed to start the study in this second hospital so far (due to maternity leave and limited time to finish a PhD)

2

Eligibility Criteria

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

You may qualify if:

  • Coronary artery bypass

You may not qualify if:

  • Significant lung disease
  • Drug abuse
  • Pregnancy
  • Major physical impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Trondheim, 7489, Norway

Location

Related Publications (1)

  • Moholdt T, Bekken Vold M, Grimsmo J, Slordahl SA, Wisloff U. Home-based aerobic interval training improves peak oxygen uptake equal to residential cardiac rehabilitation: a randomized, controlled trial. PLoS One. 2012;7(7):e41199. doi: 10.1371/journal.pone.0041199. Epub 2012 Jul 18.

    PMID: 22815970RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

RehabilitationAcademies and Institutes

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesOrganizationsHealth Care Economics and Organizations

Study Officials

  • Trine T. Moholdt, cand.polit

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

NO(1)