NCT01209637

Brief Summary

Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved. There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.

Trial Health

87
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

Timeline
Completed

Started Mar 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

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

September 24, 2010

Last Update Submit

October 25, 2016

Conditions

Stable Coronary Artery Disease

Keywords

stable coronary artery diseasesignificant coronary stenosis

Outcome Measures

Primary Outcomes (1)

  • coronary collateral blod flow

    4 weeks

Secondary Outcomes (3)

  • plaque composition within the coronary artery

    4 weeks

  • MACCE

    4 week, 6 months, 12 months

  • atherosclerosis parameter within the laboratory

    4 weeks, 3, 6, 12 months

Study Arms (3)

control

NO INTERVENTION

standard care of coronary artery diseases incl. recommended home based exercise 3x/week

Exercise training

ACTIVE COMPARATOR

exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center

Behavioral: exercise training

intensive exercise training

ACTIVE COMPARATOR

intensive exercise training incl. interval training

Behavioral: Intensive exercise training

Interventions

exercise trainingBEHAVIORAL

exercise training min. 4 times a day for at least 30 min

Exercise training
Intensive exercise trainingBEHAVIORAL

Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold

intensive exercise training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable CAD
  • min.1 coronary artery stenosis \>50%
  • patient is symptomatic ( CCS 1-3)or has documented myocardial ischemia during stress test
  • angina threshold \>75 Watt
  • informed consent

You may not qualify if:

  • Age \<18 oder \>75
  • akut coronary syndrome within 2 weeks
  • LV-EF \< 40 %
  • significant valve diseases
  • reduced patient compliance
  • muscular disorder
  • bronchial asthma or COLD stadium III and IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center Leipzig- University Leipzig

Leipzig, 04289, Germany

Location

Related Publications (2)

  • Mobius-Winkler S, Uhlemann M, Adams V, Sandri M, Erbs S, Lenk K, Mangner N, Mueller U, Adam J, Grunze M, Brunner S, Hilberg T, Mende M, Linke AP, Schuler G. Coronary Collateral Growth Induced by Physical Exercise: Results of the Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable Coronary Artery Disease (EXCITE) Trial. Circulation. 2016 Apr 12;133(15):1438-48; discussion 1448. doi: 10.1161/CIRCULATIONAHA.115.016442. Epub 2016 Mar 15.

    PMID: 26979085DERIVED

  • Uhlemann M, Adams V, Lenk K, Linke A, Erbs S, Adam J, Thiele H, Hilberg T, Gutberlet M, Grunze M, Schuler GC, Mobius-Winkler S. Impact of different exercise training modalities on the coronary collateral circulation and plaque composition in patients with significant coronary artery disease (EXCITE trial): study protocol for a randomized controlled trial. Trials. 2012 Sep 14;13:167. doi: 10.1186/1745-6215-13-167.

    PMID: 22974129DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sven Möbius-Winkler, MD

    Heart Center Leipzig- University Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 27, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)