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

November 19, 2020 updated by: Al Shaymaa Shaaban Abd El Azeim, Cairo University

Effect of Trunk Stabilizing Exercises on Sternal Instability and Separation in Patients With Median Sternotomy After Heart Valve Surgery: A Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 12511
        • Al Shaymaa Shaaban Abd El Azeim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: trunk stabilizing exercise
trunk stabilizing exercises three times/week for four weeks
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.
Other: 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
ACTIVE_COMPARATOR: cardiac rehabilitation programe
cardiac rehabilitation program three times/week for four weeks
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sternal separation
Time Frame: it will be measured after four weeks
ultrasound unit will be used to measure the transverse distance between the two edges of stenum
it will be measured after four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sternal instability
Time Frame: it will be measured after four weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 21, 2020

Primary Completion (ANTICIPATED)

December 25, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (ACTUAL)

November 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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