Effect Of Bioelectric Therapy On Sternal Instability In Patients With Median Sternotomy After Heart Valve Surgery
SI
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJuly 2, 2021
June 1, 2021
3 months
June 25, 2021
June 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
sternal separation
up to four weeks
Study Arms (2)
bioelectric therapy
EXPERIMENTALpatients will receive micro-current electrical stimulation three times/week for four weeks
cardiac rehabilitation programe
ACTIVE COMPARATORpatients will receive a cardiac rehabilitation program three times/week for four weeks
Interventions
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.
the patient will receive cardiac rehabilitation program
Eligibility Criteria
You may qualify if:
- there age between 40 and 50 years,
- hemodynamic stability
- BMI from 25 to 29.9 kg/m2,
- they will have acute sternal instability.
You may not qualify if:
- previous thoracic surgery
- elective and urgent coronary artery bypass surgery
- respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood \<60 mmHg
- renal insufficiency with serum creatinine ≥1.8 mg/dl after surgery
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- random generator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- al shaymaa shaaban abd el azeim
Study Record Dates
First Submitted
June 25, 2021
First Posted
July 2, 2021
Study Start
July 15, 2021
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
July 2, 2021
Record last verified: 2021-06