Trial document




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  DRKS00000527

Trial Description

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Title

Effect of preoperative exercise training on circulating angiogenic cells in patients with metabolic syndrome – a randomised controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with metabolic syndrome will perform cardiopulmonary exercise over 1 month before surgery in order to stimulate angiogenic cells, which play an important in the regeneration process of the vasculature. The quantity and functional quality of these cells will be compared between the exercise and non-exercise (control) group and will analysed over a period of 10 days postoperatively.

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Brief Summary in Scientific Language

An increasing number of patients with metabolic syndrome present for surgery. The underlying cardiovascular risk, characterized by endothelial dysfunction, increases the risk for perioperative vascular complications1. Circulating angiogenic cells (CACs), through their paracrine effects, play a central role in the regeneration of the injured endothelium2. Several studies have shown that exercise capacity mobilizes CACs and improves endothelial function3-6; however this effect has only been studied in healthy subjects and in a postoperative setting. No studies have investigated on the effect of preoperative exercise training (prehabilitation) on the quantity and quality of CACs.
In this randomized, controlled trial we test the hypothesis, that one month of preoperative exercise training increases the number of CACs and improves their functional quality in patients with metabolic syndrome.
The primary endpoint is to study the difference in quantity and quality of CACs between the exercise and non-exercise groups in response to two stress stimuli (preoperative cardiopulmonary exercise stress testing and surgical trauma). CACs will be assessed with flow-cytometry (quantitative analysis using CD31+, CD34+, CD133+, VEGFR2+) and tube formation assay (functional analysis) following cardiopulmonary exercise testing conducted at baseline and one month after exercise training, and then following surgery (postoperative Day 1 and Day 10).

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Organizational Data

  •   DRKS00000527
  •   2010/09/14
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  •   yes
  •   Approved
  •   10-073, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   Endothelial Dysfunction
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Interventions/Observational Groups

  •   Diagnostic cardiopulmonary exercise testing (1) and additional preoperative exercise training (2); 1: a) one month preoperatively and b) two days preoperatively; 2: a) exercise training over 1 month preoperatively; 3 x per week at minimum; b) no training postoperatively
  •   Diagnostic cardiopulmonary exercise testing
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
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Primary Outcome

Assessment of quantity and quality of circulating angiogenic cells (CACs) following a physiologic stimulus (cardiopulmonary exercise testing / CPET) and postoperatively after surgical injury. CACs will be analyzed via FACS analysis using the following markers: CD34, CD133, CD309, VEGFR-2; in addition a functional analysis will be performed using 1. colony forming assay; 2. matrigel tube formation assay. Differences between the intervention group (exercise group) and the control group will be analyzed not only after the 1. and 2. CPET (preoperatively) but also on day 1, 3 and 10 after surgery.

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Secondary Outcome

Postoperative outcome:
1.Incidence of vascular-related complications
2.Length of stay
3.Length of ICU stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2014/12/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion criteria:
1. Patients who have signed the consent form to participate in the study
2. Patients scheduled and cleared for:
- Major orthopaedic surgery including:
Degenerative spine surgery [posterior lumbal interrbody fusion (PLIF)] and tumor surgery
- Major gynaecologic surgery including:
Tumor surgery requiring laparotomy (including patients after neoadjuvant therapy)
Breast reconstructive surgery (including transverse rectus abominus muscle = TRAM flap surgery)
Incontinence surgery
Note: Both surgery groups include preconditions that are feasible for cycle exercise; symptom-limited patients will be excluded (see exclusion criteria)
3. Diagnosis of Metabolic Syndrome according to International Diabetes Federation Criteria (IDF, 2006)34 => central obesity plus any two of the following four factors:
• Central obesity:
Waist circumference (Europid) ≥94 cm in men and ≥80 cm in women (ethnic specific values for other population groups applicable)
• Insulin resistance
Fasting plasma glucose ≥100 mg/dl (5.6 mM) or previously diagnosed type II diabetes
• Lipid profile
Triglyceride ≥150 mg/dl (1.7 mM) or specific treatment for this lipid abnormality
HDL-C <40 mg/dl (1.03 mM) in males and <50 mg/dl (1.29 mM) in females or specific treatment for this lipid abnormality
• Hypertension
Systolic blood pressure (BP) ≥130 or diastolic BP ≥85 mmHg, or treatment of previously diagnosed hypertension
• Others
Additional metabolic criteria supportive of but not essential for the diagnosis
4. Patients 18 years of age or older

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Exclusion Criteria

Exclusion criteria:
1. Patients under age 18
2. Patients unwilling to sign consent
3. Patients with advanced tumor progression in a physical condition unable to exercise
4. Patients with scheduled surgery earlier than planned study period (no delay of surgical time point for study reason)
5. Patients unable to exercise or metabolic equivalent <5 in performance status (bedridden or wheel chair bound >50% of walking hours)
6. Patients after myocardial infarction within three month of visiting the anaesthesia clinic or patients with new or unstable angina
7. Patients with a history of a cerebrovascular accident or transit ischaemic attacks within three month of visiting anaesthesia clinic
8. Patients with a history of a pulmonary embolic event within three month of visiting the anaesthesia clinic.
9. Patients known to have acute or chronic deep vein thrombosis
10. Any patient whose condition is deemed unsatisfactory for surgery after pre-anaesthetic evaluation
11. Pregnant patients

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Addresses

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    • Uniklinik Köln
    • Mr.  Dr.  Robert  Schier 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln
    • Mr.  Dr.  Robert  Schier 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln
    • Mr.  Dr.  Robert  Schier 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (DFG)
    • 53170  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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