Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery

Valvular Heart Disease Clinical Trial

— SIS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04632914
• Other study ID #: P.T.REC/012/002895
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 21, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: al shaymaa sh abd el azeim, lecturer
• Phone: 01033771553
• Email: alshaymaa.shaaban[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• trunk stabilizing exercise
trunk stabilizing exercise is a group of exercise which train the anterior thoracic cage and abdominal muscles in the form of static contraction of these muscles from a different position supine, sitting and standing.
• cardiac rehabilitation programe
all patients continue this routine physiotherapy program for 40-60min.the patients incorporated into a variety of exercises conducted through arm ergometer,leg ergometer and treadmill.also the patients perform deep breathing exercise and coughing ececise

Locations

Country	Name	City	State
Egypt	Al Shaymaa Shaaban Abd El Azeim	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sternal separation	ultrasound unit will be used to measure the transverse distance between the two edges of stenum	it will be measured after four weeks
Secondary	sternal instability	sternal instability scale will be used to assess the integrity of the sternum and transferring the results of the assessment to an acceptable grade	it will be measured after four weeks