NCT01246570

Brief Summary

It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration 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

November 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2.4 years

First QC Date

November 16, 2010

Last Update Submit

September 24, 2014

Conditions

Keywords

exerciseheartcoronary diseaserehabilitation

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake

    The change in peak oxygen uptake from baseline to 12 months after baseline. In the intervention group, the peak oxygen uptake will be measured also every 3 months during the intervention period, and this will be reported

    baseline and 12 months

Secondary Outcomes (7)

  • Myocardial infarction

    baseline and 12 months

  • Hospital readmission

    baseline and 12 months

  • Death

    baseline and 12 months

  • Endothelial function

    baseline and 12 months

  • Quality of life

    baseline and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Maintenance program

EXPERIMENTAL

Patients will attend a "motivational exercise session" once monthly. They will also be tested (exercise test with measurement of peak oxygen uptake) every third months.

Behavioral: Exercise training

Control

ACTIVE COMPARATOR

Usual care. The patients will receive the usual care provided by the hospital and community health services

Other: Control

Interventions

The patients will meet for organized exercise training once monthly and also exercise testing every third month.

Maintenance program
ControlOTHER

The patients will receive the usual care provided by the hospitals and the community health services

Control

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary heart disease patients

You may not qualify if:

  • unstable angina pectoris
  • hemodynamic significant valve disease (\> New York Heart Association class II)
  • pregnancy
  • left ventricular ejection fraction \<30%
  • kidney failure (creatinin \> 140)
  • uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

  • Madssen E, Arbo I, Granoien I, Walderhaug L, Moholdt T. Peak oxygen uptake after cardiac rehabilitation: a randomized controlled trial of a 12-month maintenance program versus usual care. PLoS One. 2014 Sep 23;9(9):e107924. doi: 10.1371/journal.pone.0107924. eCollection 2014.

MeSH Terms

Conditions

Coronary DiseaseMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Trine Moholdt, Phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 23, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2013

Study Completion

January 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations