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Clinical Trials/DRKS00000527
DRKS00000527
Active, Not Recruiting
N/A

Effect of preoperative exercise training on endothelial progenitor cells in patients undergoing laparotomy – a randomised controlled trial

niklinik Köln0 sites15 target enrollmentSeptember 14, 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
niklinik Köln
Enrollment
15
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 14, 2010
End Date
July 1, 2020
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niklinik Köln

Eligibility 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:

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

Outcomes

Primary Outcomes

Not specified

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