Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery (SI)

Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial

The aim of this study is to investigate the effect of bioelectric therapy on sternal instability in patients with median sternotomy after heart valve surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Valve Surgery
• Intervention / Treatment: Other: bioelectric therapy; Other: cardiac rehabilitation program

Detailed Description

Valvular heart disease constitutes a growing healthcare problem with a general prevalence of 2%-5% and a prevalence of 13% after the age of 75 years Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease. Nevertheless, following the surgery, up to 27% of patients may require readmission within 30 days after discharge. Following heart valve surgery, some patients report anxiety and worries related to readmission and reoperations, postoperative complications, and deconditioning which may prevent or delay return to work and limit activities of daily living.Over the past 30 years, bone-growth stimulators have become a critical component in fracture care. They can be classified into four categories: direct-current (DC) devices, inductive coupling, noninvasive capacitive coupling, and low-intensity ultrasound. Microcurrent electrical stimulation ( MES) is the therapeutic use of constant (DC) and pulsed (interrupted) currents, where the stimulus amplitude is in the micro amperage (millionth of an ampere) range. MES is defined as those of less than 1 mA or 1000 μ, (MES < 1 mA). This form of electrical stimulation tends to be applied at the suspensory or very low sensory level and they are not designed to stimulate muscle contraction. Generators that produce MES were originally called microcurrent electrical neuromuscular stimulators (MENS). However, the stimulation pathway is not the usual neural pathway, and they are not designed to stimulate muscle contraction. Consequently, this type of generator was subsequently referred to as a microcurrent electrical stimulator (MES). The use of MES may be an adjunctive modality in the treatment of fractures or injury sites, especially fractures prone to nonunion. Fracture healing may be accelerated by passing a monophasic current through the fracture site. Getting the current into the bony area without an invasive technique is difficult.forty subjects will be allocated to two groups; one group will receive micro-current therapy and routine cardiac rehabilitation program both for four weeks and the control group will receive the cardiac rehabilitation program only for four weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. there age between 40 and 50 years,
2. hemodynamic stability
3. BMI from 25 to 29.9 kg/m2,
4. they will have acute sternal instability.

Exclusion Criteria:

1. previous thoracic surgery
2. elective and urgent coronary artery bypass surgery
3. respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood <60 mmHg
4. renal insufficiency with serum creatinine ≥1.8 mg/dl after surgery
5. low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias, or hypotension, according to the American College of Cardiology Foundation and American Heart Association

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bioelectric therapy; patients will receive micro-current electrical stimulation three times/week for four weeks	Other: bioelectric therapy; the patient will receive microcurrent therapy from a supine lying position. the negative electrode on the incision area and the positive electrode proximal. the intensity will be less than 20 microamperes and frequency at 20 HZ.; Other: cardiac rehabilitation program; the patient will receive cardiac rehabilitation program
Active Comparator: cardiac rehabilitation programe; patients will receive a cardiac rehabilitation program three times/week for four weeks	Other: cardiac rehabilitation program; the patient will receive cardiac rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sternal instability	sternal instability scale will be used for assessment. this scale has four points. zero mean more stability and three mean completly separated	up to four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sternal separation	ultrasound unit will be used for assessing the separation between sternum edges	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2021
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: heart valve surgery; bioelectric therapy; median sternotomy
• Other Study ID Numbers: p.t.REC/012/003250

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No