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"Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients" (CardioVIB)

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ClinicalTrials.gov Identifier: NCT04243213
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Nandu Goswami, Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Frailty Other: Vibration Plate Other: Tilti at 15° only Other: standard hospital mobilization/therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: "Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients"
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Vibration Group
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
Other: Vibration Plate
Vibration at 15° tilt, which means the patients partly use their own body weight (resistive vibration exercise).

Other: standard hospital mobilization/therapy
early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients

Experimental: 15° Tilt Group
Intervention group II is positioned postoperatively from day 2 to day 7 for 15 minutes at 15 degrees, but without vibration
Other: Tilti at 15° only
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.

Other: standard hospital mobilization/therapy
early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients

Placebo Comparator: Control Group
The control group only receives standard physiotherapy and no further treatments
Other: standard hospital mobilization/therapy
early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients




Primary Outcome Measures :
  1. Cardiopostural Control [ Time Frame: changes comparing at following time-points: pre surgery + post surgery (24 hours, 7 days and 3 months) ]
    Changes in heart rate during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)

  2. Cardiopostural Control [ Time Frame: changes comparing at following time-points: pre surgery + post surgery (24 hours, 7 days and 3 months) ]
    Changes in blood pressure during sit-to-stand test before and after surgery as well as after rehabilitation (3 months follow up)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243213


Locations
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Austria
Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Heinrich Mächler, Prof. Dr.    004331638573852    heinrich.maechler@medunigraz.at   
Contact: Goswami Nandu, Assoz. Prof. Dr.    004331638573852    nandu.goswami@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Nandu Goswami, Assoz. Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT04243213    
Other Study ID Numbers: CardioVIB
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nandu Goswami, Medical University of Graz:
early mobilisation after hospitalisation
Additional relevant MeSH terms:
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Frailty
Pathologic Processes