AzTrials
AzTrials

Coronary Artery DiseaseNCT04111744

Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery

A study testing Preoperative Exercise Training and Optimal medical therapy in people with Coronary Artery Disease and Physical Activity, run by Kerckhoff Klinik at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Patients (pts) with stable coronary artery disease (CAD) requiring coronary artery bypass graft surgery (CABG) may be physically inactive during the waiting period to avoid further risks. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Preoperative Exercise Training and Optimal medical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteGermany
Study dates
1 Jan 2015to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • stable Angina
  • indication for elective CABG surgery
  • functional capacity > 50 watts
  • willingness to participate in the study

Who cannot join

  • unstable Angina
  • comorbidities precluding performance of aerobic exercise training (e.g. neurological disorders, orthopedic disorders etc)
  • functional Status NYHA IV
  • relevant ventricular arrhythmias
  • hemodynamic significant heart valve disease
  • myocarditis
Show all 12Show fewer
  • cardiomyopathies
  • left main coronary artery disease > 50%
  • peripheral obstructive disease (Fontaine > IIb)
  • reduced life expectancy < 12 months
  • CABG surgery during the last six months
  • participation in another trial

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Kerckhoff Klinik

    Bad Nauheim, 61231

Other trials in Germany

About this study

Official title: Preoperative Excercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial

Patients (pts) with stable coronary artery disease (CAD) requiring coronary artery bypass graft surgery (CABG) may be physically inactive during the waiting period to avoid further risks. Aim of this study is to investigate the feasibility and safety of a preoperative aerobic exercise training in these pts during the waiting period and to analyze its effects on pre-, peri and postoperative outcomes

Read the detailed description

Pts with stable coronary artery disease (CAD) and indication for elective CABG will be prospectively randomized into a preoperative training group (TG) or a non active control group (CG). Pts in TG have to perform six sessions of aerobic endurance training within two weeks prior to CABG. The following investigations will be performed at baseline, one day before surgery and at the beginning and at the end of cardiac rehabilitation: a maximal symptom limited ergospirometry, assessment of endothelial function (analysing the reactive hyperaemic index (RHI) via a finger-tonometry), assessment of quality of life (QoL) using the MacNew Heart Disease Questionnaire, laboratory testing of ischemic and inflammatory Parameters. Baseline, peri- and postoperative characteristics will be collected.

Being tested
Preoperative Exercise Training, Optimal medical therapy
Keywords
Coronary Artery Bypass Graft Surgery, Physical Activity, Coronary Artery Disease, Physical Training
Medical subject headings
Coronary Artery Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Exercise TrainingOther

    Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery

  • Optimal medical therapyOther

    Standard medication for stable CAD

Study groups in NCT04111744
Study groupRoleWhat they receive
Training GroupExperimentalPreoperative Exercise Training Optimal medical therapy,
Receives: Other: Preoperative Exercise Training; Other: Optimal medical therapy
Control GroupOtherOptimal medical therapy, inactive control group
Receives: Other: Optimal medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiopulmonary fitness

    Change of maximal Oxygen consumption

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation

  2. Endothelial function

    Change of Reactive hyperemic index (RHI)

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day (postoperative day 7-14), after 3 weeks of cardiac rehabilitation

Secondary outcomes (21)

  1. Length of hospital stay (LoS)

    Duration of hospital stay in days

    Measured: Within the acute care period

  2. Length of ventilation

    Duration of Ventilation in minutes

    Measured: Within the acute care period

  3. Functional capacity

    Change of 6-minute walk test

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  4. Arterial stiffness

    Changes in arterial pulse wave analysis

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  5. Quality of life Questionnaire 1

    Changes in MacNew (Heart Disease Health-related Quality of Life-) Questionnaire questionaire

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  6. Quality of life Questionnaire 2

    Changes in Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale that generates ordinal data.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  7. Quality of life Questionnaire 3

    Changes in Mobility and Self-supply (MOSES) questionnaire

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  8. Ischemic blood marker 1

    High Sensitive Troponin (hs-Trop)

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  9. Ischemic blood marker 2

    Creatine kinase (CK) U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  10. Ischemic blood marker 3

    Creatine Kinase-MB (CK-MB) U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  11. Ischemic blood marker 4

    Lactate dehydrogenase (LDH) U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  12. Ischemic blood marker 5

    glutamic oxaloacetic transaminase (GOT) U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  13. Ischemic blood marker 6

    glutamate pyruvate transaminase (GPT) U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  14. Ischemic blood marker 7

    copeptin U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  15. Inflammatory blood marker 1

    C-reactive protein (CRP) U/L

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  16. Inflammatory blood marker 2

    Leucozytes 10³/µL

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  17. Inflammatory blood marker 3

    Interleukine-6 (IL-6) pg/mL

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  18. Number of patients with a Clinical Event

    Atrial fibrillation documented by electrocardiogram (ECG)

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  19. Number of patients with a Pulmonary clinical event

    Pleural effusion, pulmonary infection or other pulmonary disorder with Need for treatment

    Measured: Baseline, prior surgery on hospital admission day, hospital discharge day(postoperative day 7-14), , after 3 weeks of cardiac rehabilitation

  20. Number of patients with a Cardiovascular event

    Revascularization, re-CABG, rehospitalization due to unstable angina, myocardial infarction

    Measured: after 30 days and 12 months

  21. Number of patients with a Cerebrovascular event

    TIA, stroke

    Measured: after 30 days and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start1 Jan 2015
  3. Primary completion30 Jun 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients enrolled to the study were randomised in a Treatment and a control Group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04111744
Sponsor's protocol ID
PRECAB
Status last verified
Sep 2019
First submitted
21 Mar 2018
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.

    PubMed 32546065

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative Exercise Training and Optimal medical therapy in people with Coronary Artery Disease and Physical Activity, run by Kerckhoff Klinik at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary fitness (time frame: Baseline, prior surgery on hospital admission day, hospital discharge day ( postoperative day 7-14) , after 3 weeks of cardiac rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04111744, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in