"Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients" (CardioVIB)
Primary Purpose
Cardiovascular Risk Factor, Frailty
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Vibration Plate
Tilt at 15°
Standard hospital mobilization
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiovascular Risk Factor focused on measuring early mobilisation after hospitalisation
Eligibility Criteria
Inclusion Criteria:
- Patients who undergo heart surgery: aortic valve replacement or elective coronary bypass
Exclusion Criteria:
- Euroscore II > 8
- patients with a postop. delirium on day 2 (drug treatment)
- Patients who require higher-dose catecholamines 48h post surgery (norepinephrine over 0.05-0.1 micrograms / kg body weight, suprarenin over 0.05-0.1 micrograms / kg body weight, Dobutrex over 5 micrograms / kg body weight)
- existing thrombosis
Sites / Locations
- Medical University of GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Vibration Group
15° Tilt Group
Control Group
Arm Description
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
Intervention group II is positioned postoperatively from day 2 to day 7 for 15 minutes at 15 degrees, but without vibration
The control group only receives standard physiotherapy and no further treatments
Outcomes
Primary Outcome Measures
Cardiopostural Control (heart rate)
Changes in heart rate during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)
Cardiopostural Control (systolic blood pressure)
Changes in systolic blood pressure during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)
Cardiopostural Control (diastolic blood pressure)
Changes in diastolic blood pressure during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)
Secondary Outcome Measures
Full Information
NCT ID
NCT04243213
First Posted
January 20, 2020
Last Updated
March 8, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04243213
Brief Title
"Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients"
Acronym
CardioVIB
Official Title
"Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factor, Frailty
Keywords
early mobilisation after hospitalisation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 15 minutes at 15 degrees, but without vibration C: The control group only receives standard physiotherapy and no further treatments
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vibration Group
Arm Type
Experimental
Arm Description
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
Arm Title
15° Tilt Group
Arm Type
Experimental
Arm Description
Intervention group II is positioned postoperatively from day 2 to day 7 for 15 minutes at 15 degrees, but without vibration
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group only receives standard physiotherapy and no further treatments
Intervention Type
Other
Intervention Name(s)
Vibration Plate
Intervention Description
Vibration at 15° tilt, which means the patients partly use their own body weight (resistive vibration exercise).
Intervention Type
Other
Intervention Name(s)
Tilt at 15°
Intervention Description
To compare if a possible effect derives from the vibration or the tilting only, a second group was added who will only receive 10 min of 15° tilt without the vibration.
Intervention Type
Other
Intervention Name(s)
Standard hospital mobilization
Intervention Description
early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients
Primary Outcome Measure Information:
Title
Cardiopostural Control (heart rate)
Description
Changes in heart rate during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)
Time Frame
changes comparing at following time-points: pre surgery + post surgery (24 hours, 7 days and 3 months)
Title
Cardiopostural Control (systolic blood pressure)
Description
Changes in systolic blood pressure during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)
Time Frame
changes comparing at following time-points: pre surgery + post surgery (24 hours, 7 days and 3 months)
Title
Cardiopostural Control (diastolic blood pressure)
Description
Changes in diastolic blood pressure during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)
Time Frame
changes comparing at following time-points: pre surgery + post surgery (24 hours, 7 days and 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who undergo heart surgery: aortic valve replacement or elective coronary bypass
Exclusion Criteria:
Euroscore II > 8
patients with a postop. delirium on day 2 (drug treatment)
Patients who require higher-dose catecholamines 48h post surgery (norepinephrine over 0.05-0.1 micrograms / kg body weight, suprarenin over 0.05-0.1 micrograms / kg body weight, Dobutrex over 5 micrograms / kg body weight)
existing thrombosis
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinrich Mächler, Prof. Dr.
Phone
004331638573852
Email
heinrich.maechler@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Goswami Nandu, Assoz.Prof.
Phone
004331638573852
Email
nandu.goswami@medunigraz.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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"Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients"
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