Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04243213 |
| Other study ID # |
CardioVIB |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
Medical University of Graz |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The rapid mobilization of cardiac surgery patients within the first 48 postoperative hours in
the intensive care unit is common practice and decisive for the outcome, especially in this
group (over 65 years). If sitting on the edge of the bed was successful, a standing attempt
is usually made. Both can be accompanied by blood pressure dysregulations in the sense of
hypotensive phases as well as dizziness. Postural control is the ability of the body to
balance an upright body position under the influence of gravity.The aim of the study is to
investigate whether training with the Galileo device by means of vibration on the soles of
the feet and / or by changing the position to 15 ° can improve the postural control and thus
the postoperative mobilization of patients.
Description:
The aim of this study is to determine whether vibrations on the sole of the foot accelerate
mobilization after cardiac surgery. Preliminary studies show that the mechanisms of
cardiovascular regulation in the event of changes in position, e.g. when getting up from the
lying position, can be positively influenced by vibration treatments on the soles of the
feet, if at the same time a small part of the body weight is shifted to the soles of the
feet. In the early phase after the operation, you may feel dizzy when you get up, which
creates uncertainty in the patient, which in turn delays further mobilization.The sole of the
foot vibrations and various measurements of the cardiovascular regulation are carried out in
this study.
This study is carried out by the clinical department for cardiac surgery together with the
chair of physiology at the Medical University of Graz. Thirty patients will participate in
this study. Through a random selection process, the patients are divided into three groups of
10 patients each and receive the following treatment in addition to standard clinical
physiotherapy:
A: Intervention group I receives a unit of 10 minutes daily on the vibrating plate with an
upright posture of 15 ° postoperatively from the 2nd to the 7th day B: Intervention group II
is positioned postoperatively from day 2 to day 7 for 10 minutes at 15 degrees, but without
vibration C: The control group only receives standard physiotherapy and no further treatments
Standard physiotherapy consists of the patient trying to stand up together with the
physiotherapist from the intensive care bed or IMC bed. The participation in this clinical
trial will take approximately 60 minutes per appointment. This consists of 20-25 minutes for
attaching the electrodes, 15 minutes for the "sit-to-stand test" and 15-20 minutes for the
survey (filling out the questionnaires). At the beginning of the study or before the
operation (OP), questionnaires are used to determine whether you have an increased risk of
falling and whether you are frail. These questionnaires will be carried out by trained
employees together with you during the initial measurement, upon discharge and after about 3
months.
To measure the cardiovascular regulation during changes in position, a sit-up test is carried
out. Values such as blood pressure and cardiac output (Task Force Monitor), muscle activity
on the calf over the skin and vascular reaction in the calf over the skin, and blood flow to
the brain are measured with a Ultrasound device included. All methods used are non-invasive
(that is, only adhesive electrodes are used on the skin and no needles or syringes, there is
no blood draw in this measurement) and not painful. The patient will be asked to participate
in such a sit-up test (from supine/lying position to standing upright) at a total of 5
measuring dates. In total the patient will be given two blood pressure cuffs, one on the
right upper arm, the second on the left middle finger. To measure the ECG and other
cardiovascular values, 8 electrodes are attached to your upper body. In addition there are 3
adhesive electrodes on the calves for measuring the muscles. No additional blood tests are
carried out as part of the tests. The results of your routine blood tests will be included in
the study.
All measurements from the patients in group A-C are compared to determine whether training
with the vibration exercise leads to faster mobilization after cardiac surgery.
