Effect of preoperative exercise training on endothelial progenitor cells in patients undergoing laparotomy – a randomised controlled trial
- Conditions
- Endothelial Dysfunction
- Registration Number
- DRKS00000527
- Lead Sponsor
- niklinik Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 15
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Postoperative outcome:<br>1.Incidence of vascular-related complications<br>2.Length of stay<br>3.Length of ICU stay