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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04949581
Collaborator
(none)
40
2
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: bioelectric therapy
  • Other: cardiac rehabilitation program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
bioelectric therapy and routine cardiac rehabilitation programbioelectric therapy and routine cardiac rehabilitation program
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
random generator
Primary Purpose:
Treatment
Official Title:
Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial
Anticipated Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. sternal instability [up to four weeks]

    sternal instability scale will be used for assessment. this scale has four points. zero mean more stability and three mean completly separated

Secondary Outcome Measures

  1. sternal separation [up to four weeks]

    ultrasound unit will be used for assessing the separation between sternum edges

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Al Shaymaa Shaaban Abd El Azeim, al shaymaa shaaban abd el azeim, Cairo University
ClinicalTrials.gov Identifier:
NCT04949581
Other Study ID Numbers:
  • p.t.REC/012/003250
First Posted:
Jul 2, 2021
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Al Shaymaa Shaaban Abd El Azeim, al shaymaa shaaban abd el azeim, Cairo University

Study Results

No Results Posted as of Jul 2, 2021