NCT04632914

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

November 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 29, 2020

Last Update Submit

November 19, 2020

Conditions

Valvular Heart Disease

Keywords

Trunk stabilizing exercises

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • sternal instability

    it will be measured after four weeks

Study Arms (2)

trunk stabilizing exercise

EXPERIMENTAL

trunk stabilizing exercises three times/week for four weeks

Other: trunk stabilizing exerciseOther: cardiac rehabilitation programe

cardiac rehabilitation programe

ACTIVE COMPARATOR

cardiac rehabilitation program three times/week for four weeks

Other: cardiac rehabilitation programe

Interventions

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.

trunk stabilizing exercise
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

cardiac rehabilitation programetrunk stabilizing exercise

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 40 and 50 years, female gender
  • hemodynamic stability
  • BMI from 25 to 29.9 kg/m2
  • they will have acute sternal instability.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Shaymaa Shaaban Abd El Azeim

Giza, 12511, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35753968DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

al shaymaa sh abd el azeim, lecturer

CONTACT

01033771553alshaymaa.shaaban@pt.cu.edu.eg

al shaymaa sh abd el azeim, lecturer

CONTACT

01033771553alshaymaa.ahaaban@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: trunk stabilizing exercises and cardiac rehabilitation program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 17, 2020

Study Start

November 21, 2020

Primary Completion

December 25, 2020

Study Completion

December 30, 2020

Last Updated

November 20, 2020

Record last verified: 2020-10

Locations

EG(1)