Rehabilitation after heart valve surgery
"Postoperative Mobilization and Bottle-P.E.P. in Heart Valve Surgery:A Prospective Randomized Controlled Study "
This study is testing if early movement and a special breathing device can help people recover better after heart valve surgery compared to standard rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Istanbul Saglik Bilimleri University Academic / other |
| Locations | 1 site (Istanbul, Uskudar) |
| Trial ID | NCT06493123 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of postoperative early mobilization and the use of Bottle-P.E.P. on respiratory function and physical capacity in patients who have undergone heart valve surgery. Participants will be randomly assigned to one of three groups: a control group receiving conventional rehabilitation, a group receiving conventional rehabilitation with Bottle-P.E.P., and a group receiving conventional rehabilitation with early mobilization. Evaluations will be conducted preoperatively and 5-7 days post-surgery, measuring respiratory parameters and functional capacity through pulmonary function tests and a 6-minute walk test. Statistical methods will be used to compare outcomes between the groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-75 who are undergoing heart valve surgery via sternotomy and have stable hemodynamic values.
Not a fit: Patients with significant comorbidities, such as uncontrolled arrhythmias or active malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and improve respiratory function in patients after heart valve surgery.
How similar studies have performed: Other studies have shown positive outcomes with early mobilization and rehabilitation techniques in postoperative cardiac patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * After heart valve surgery: Patients undergoing valvular surgery via sternotomy * Same surgical technique (from med-sternum) * Age group (25-75 Y) * Stable hemodynamic values (stable vital signs, normal temperature, etc.) * Full awareness of time and space Exclusion Criteria: * Ejection Fraction 35 % * Any Male/female patient \<25 or \>75 * Body Mass Index (BMI) ≥ 38 kg/m2 * Intubation time \>6 hours after surgery * Uncontrolled arrhythmias * Rheumatoid arthritis, other inflammatory and autoimmune diseases * Active malignancy * Cardiac pacemaker or defibrillator * Mental health disorders * Any postoperative complication (general muscle weakness, wound infection of the sternum or leg, stroke.) * Refusal to assist in data collection
Where this trial is running
Istanbul, Uskudar
- Istanbul Provincial Health Directorate Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital — Istanbul, Uskudar, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Dilek Ünsal, PhD MSc PT
- Email: ptdilek23@gmail.com
- Phone: +90 530 4641198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.