Clinical trial NCT04632914: Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery
Official title: Effect of Trunk Stabilizing Exercises on Sternal Instability and Separation in Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valvular Heart Disease
Keywords: Trunk stabilizing exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: trunk stabilizing exercises and cardiac rehabilitation program
Primary purpose: TREATMENT

Brief summary: PURPOSE:

The aim of this study is to investigate the effect of trunk stabilizing exercises on sternal instability in patients with median sternotomy after heart valve surgery

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 Trunk stabilizing exercises train and activate the abdominal and anterior thoracic cage muscles to assist in stabilizing the bisected sternum, thereby decreasing the undue motion in both sagittal and transverse planes during trunk movement. Patients' complaints of pain and discomfort associated with sternal instability post-cardiac surgery may be managed by diminishing the degree of this undue motion between the edges of the divided sternum, and thus provides a conservative treatment for sternal instability forty female patients will be divided into two groups. group A received trunk stabilizing exercise and group B will receive routine cardiac rehabilitation; three times/week for four weeks. the outcome variables were sternal instability and sternal separation and measured before and after completion of treatment

Eligibility criteria: Inclusion Criteria:

1. age between 40 and 50 years, female gender
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
6. other medical conditions such as diabetes, uncontrolled hypertension and obesity
7. Past medical history that include conditions that may have influenced the provision of physiotherapy interventions such as (severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse

Primary outcomes:
measure: sternal separation
timeFrame: it will be measured after four weeks
Secondary outcomes:
measure: sternal instability
timeFrame: it will be measured after four weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Al Shaymaa Shaaban Abd El Azeim
Study officials:
References:
citation: Essam El-Sayed Felaya ES, Abd Al-Salam EH, Shaaban Abd El-Azeim A. Trunk stabilising exercises promote sternal stability in patients after median sternotomy for heart valve surgery: a randomised trial. J Physiother. 2022 Jul;68(3):197-202. doi: 10.1016/j.jphys.2022.06.002. Epub 2022 Jun 23.