Evaluation of the influence of whole-body vibration training on pre-, peri- and post-interventional performance in patients with aortic valve stenosis
- Conditions
- I35.0Aortic (valve) stenosis
- Registration Number
- DRKS00027542
- Lead Sponsor
- Allgemeine und Interventionelle Kardiologie, Elektrophysiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Herzzentrum der Uniklinik Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
Patient age > 18 years,
Indication for TAVI,
signed informed consent form,
Stable cardiac therapy and symptoms for = 1 month before screening
Decompensated heart failure during screening, Coronary artery disease requiring intervention, Constrictive pericarditis, uncontrolled severe (life-threatening) arrhythmias, Hemodynamically relevant mitral valve disease, Chronic obstructive pulmonary disease (FEV1 < 50% of target), Severe restrictive lung disease (TLC <70% of target), Significant anemia (hemoglobin < 8 mg/dl), Significant peripheral arterial disease (Fontaine = IIb), Musculoskeletal disease contributing to reduced exercise capacity, Specific cardiomyopathy (e.g. amyloidosis), Bypass surgery within the last 90 days, Inability to perform the exercise program (mentally, physically) or inability to perform essential or inability to obtain essential information (questionnaire information), uncontrolled hypertension (=140/90 mmHg or =160/100 mmHg with 3 antihypertensive medications) or resting heart rate = 115 b.p.m.), Expected low cooperation (participation 3-4 per week at center not possible), rehabilitation with other exercise regimens within 2 months prior to inclusion or planned during the study phase, Acute venous thromboembolism (within the last 3 months) prior to screening, Implants in trained body regions (e.g. hip joint, TEP), Fresh fractures / bone fractures (within the last 3 months), unable to provide written informed consent, Insufficient exercise capacity (NYHA IV, immobility, other infirmities, Discontinuation of exercise testing for screening), Life expectancy < 1 year, BMI > 40 kg/m2, Symptomatic hypotension, Inclusion in further study, History of syncope 30 days prior to screening
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in cardiopulmonary exercise testing, muscle strength and improvement in 6-minute walking distance during vibration training and follow-up of 30 days
- Secondary Outcome Measures
Name Time Method Improvement of body coordination, <br>improvement of lung function, <br>improvement of maximum oxygen uptake, <br>Length of hospital stay