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

NCT ID: NCT04243213

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-06-30

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.

Conditions

Cardiovascular Risk Factor; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vibration Plate

Intervention Type: OTHER

Vibration at 15° tilt, which means the patients partly use their own body weight (resistive vibration exercise).

Tilt at 15°

Intervention Type: OTHER

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.

Standard hospital mobilization

Intervention Type: OTHER

early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients

15° Tilt Group

Intervention group II is positioned postoperatively from day 2 to day 7 for 15 minutes at 15 degrees, but without vibration

Group Type: EXPERIMENTAL

Tilt at 15°

Intervention Type: OTHER

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.

Standard hospital mobilization

Intervention Type: OTHER

early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients

Control Group

The control group only receives standard physiotherapy and no further treatments

Group Type: PLACEBO_COMPARATOR

Standard hospital mobilization

Intervention Type: OTHER

early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients

Interventions

Vibration Plate

Vibration at 15° tilt, which means the patients partly use their own body weight (resistive vibration exercise).

Intervention Type: OTHER

Tilt at 15°

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

Standard hospital mobilization

early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Nandu Goswami

Assoz. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Graz

Graz, Styria, Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Heinrich Mächler, Prof. Dr.

Role: primary

heinrich.maechler@medunigraz.at

004331638573852

Goswami Nandu, Assoz.Prof.

Role: backup

nandu.goswami@medunigraz.at

004331638573852

Other Identifiers

CardioVIB

Identifier Type: -

Identifier Source: org_study_id