DRKS00000527Active, not recruiting未知
Effect of preoperative exercise training on endothelial progenitor cells in patients undergoing laparotomy – a randomised controlled trial
niklinik Köln0 sites15 target enrollmentStarted: September 14, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
- •Additional metabolic criteria supportive of but not essential for the diagnosis
- •4.Patients 18 years of age or older
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
Investigators
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