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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

Tracking Information
First Submitted Date  ICMJE January 20, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients"
Official Title  ICMJE "Pilot Study: Effects of Vibration on Postoperative Early Mobilization of Cardiac Surgery Patients"
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cardiovascular Risk Factor
  • Frailty
Intervention  ICMJE
  • Other: Vibration Plate
    Vibration at 15° tilt, which means the patients partly use their own body weight (resistive vibration exercise).
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: Vibration Plate
    • Other: standard hospital mobilization/therapy
  • 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
    Interventions:
    • Other: Tilti at 15° only
    • Other: standard hospital mobilization/therapy
  • Placebo Comparator: Control Group
    The control group only receives standard physiotherapy and no further treatments
    Intervention: Other: standard hospital mobilization/therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243213
Other Study ID Numbers  ICMJE CardioVIB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nandu Goswami, Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Graz
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP