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

Primary Purpose

Valvular Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trunk stabilizing exercise
cardiac rehabilitation programe
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valvular Heart Disease focused on measuring Trunk stabilizing exercises

Eligibility Criteria

40 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Al Shaymaa Shaaban Abd El Azeim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

trunk stabilizing exercise

cardiac rehabilitation programe

Arm Description

trunk stabilizing exercises three times/week for four weeks

cardiac rehabilitation program three times/week for four weeks

Outcomes

Primary Outcome Measures

sternal separation
ultrasound unit will be used to measure the transverse distance between the two edges of stenum

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2020
Last Updated
November 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04632914
Brief Title
Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2020 (Anticipated)
Primary Completion Date
December 25, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
Trunk stabilizing exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
trunk stabilizing exercises and cardiac rehabilitation program
Masking
None (Open Label)
Masking Description
no masking
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
trunk stabilizing exercise
Arm Type
Experimental
Arm Description
trunk stabilizing exercises three times/week for four weeks
Arm Title
cardiac rehabilitation programe
Arm Type
Active Comparator
Arm Description
cardiac rehabilitation program three times/week for four weeks
Intervention Type
Other
Intervention Name(s)
trunk stabilizing exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
cardiac rehabilitation programe
Intervention Description
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
Primary Outcome Measure Information:
Title
sternal separation
Description
ultrasound unit will be used to measure the transverse distance between the two edges of stenum
Time Frame
it will be measured after four weeks
Secondary Outcome Measure Information:
Title
sternal instability
Description
sternal instability scale will be used to assess the integrity of the sternum and transferring the results of the assessment to an acceptable grade
Time Frame
it will be measured after four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 40 and 50 years, female gender hemodynamic stability BMI from 25 to 29.9 kg/m2 they will have acute sternal instability. Exclusion Criteria: 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 other medical conditions such as diabetes, uncontrolled hypertension and obesity 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
al shaymaa sh abd el azeim, lecturer
Phone
01033771553
Email
alshaymaa.shaaban@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
al shaymaa sh abd el azeim, lecturer
Phone
01033771553
Email
alshaymaa.ahaaban@pt.cu.edu.eg
Facility Information:
Facility Name
Al Shaymaa Shaaban Abd El Azeim
City
Giza
ZIP/Postal Code
12511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
al shaymaa sh abd el azeim, lecturer
Phone
01033771553
Email
alshaymaa.shaaban@pt.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
el-sayed E felaya, lecturer

12. IPD Sharing Statement

Citations:
PubMed Identifier
35753968
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.
Results Reference
derived

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

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