Valvular Heart DiseaseSISNCT04632914
Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery
A study testing trunk stabilizing exercise and cardiac rehabilitation programe in people with Valvular Heart Disease, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 40 to 50 years, women only
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- trunk stabilizing exercise and cardiac rehabilitation programe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Nov 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 40 and 50 years, female gender
- hemodynamic stability
- BMI from 25 to 29.9 kg/m2
- they will have acute sternal instability.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al Shaymaa Shaaban Abd El Azeim
Giza, 12511
al shaymaa sh abd el azeim, lecturer, 01033771553, alshaymaa.shaaban@pt.cu.edu.eg
el-sayed E felaya, lecturer
About this study
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
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
Read the 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
- Conditions
- Valvular Heart Disease
- Being tested
- trunk stabilizing exercise, cardiac rehabilitation programe
- Keywords
- Trunk stabilizing exercises
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trunk stabilizing exerciseOther
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 programeOther
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
| Study group | Role | What they receive |
|---|---|---|
| trunk stabilizing exercise | Experimental | trunk stabilizing exercises three times/week for four weeks Receives: Other: trunk stabilizing exercise; Other: cardiac rehabilitation programe |
| cardiac rehabilitation programe | Active comparator | cardiac rehabilitation program three times/week for four weeks Receives: Other: cardiac rehabilitation programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
sternal separation
ultrasound unit will be used to measure the transverse distance between the two edges of stenum
Measured: it will be measured after four weeks
Secondary outcomes (1)
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
Measured: it will be measured after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start21 Nov 2020 (estimated)
- Primary completion25 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- trunk stabilizing exercises and cardiac rehabilitation program
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632914
- Sponsor's protocol ID
- P.T.REC/012/002895
- Acronym
- SIS
- Status last verified
- Oct 2020
- First submitted
- 29 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35753968
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04632914
- Acronym / sponsor ID
- SIS / P.T.REC/012/002895
- Conditions
- Valvular Heart Disease
- Keywords
- Trunk stabilizing exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Nov 2020 (estimated)
- Primary completion
- 25 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- trunk stabilizing exercises and cardiac rehabilitation program
| Arm | Type | Receives |
|---|---|---|
| trunk stabilizing exercise | Experimental | Other: trunk stabilizing exercise, Other: cardiac rehabilitation programetrunk stabilizing exercises three times/week for four weeks |
| cardiac rehabilitation programe | Active comparator | Other: cardiac rehabilitation programecardiac rehabilitation program three times/week for four weeks |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 40 and 50 years, female gender
- hemodynamic stability
- BMI from 25 to 29.9 kg/m2
- they will have acute sternal instability.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trunk stabilizing exercisetrunk 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 | trunk stabilizing exercise |
| cardiac rehabilitation programeall 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 | Other | cardiac rehabilitation programe, trunk stabilizing exercise |
Primary outcome
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
1 secondary outcome
sternal instability
Time frame: it will be measured after four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 35753968Essam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trunk stabilizing exercise and cardiac rehabilitation programe in people with Valvular Heart Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact al shaymaa sh abd el azeim, lecturer (01033771553, alshaymaa.shaaban@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sternal separation (time frame: it will be measured after four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.