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Clinical Trials/DRKS00027542
DRKS00027542
Completed
N/A

Evaluation of the influence of whole-body vibration training on pre-, peri- and post-interventional performance in patients with aortic valve stenosis - Galileo-AS

Allgemeine und Interventionelle Kardiologie, Elektrophysiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Herzzentrum der Uniklinik Köln0 sites33 target enrollmentJanuary 19, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
I35.0
Sponsor
Allgemeine und Interventionelle Kardiologie, Elektrophysiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Herzzentrum der Uniklinik Köln
Enrollment
33
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 19, 2022
End Date
May 31, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Allgemeine und Interventionelle Kardiologie, Elektrophysiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Herzzentrum der Uniklinik Köln

Eligibility Criteria

Inclusion Criteria

  • Patient age \> 18 years,
  • Indication for TAVI,
  • signed informed consent form,
  • Stable cardiac therapy and symptoms for \= 1 month before screening

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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