Clinical trial NCT06493123: Cardiopulmonary Rehabilitation In Heart Valve Surgery
Official title: "Postoperative Mobilization and Bottle-P.E.P. in Heart Valve Surgery:A Prospective Randomized Controlled Study "
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Valve Diseases
Keywords: heart valve surgery
bottle-P.E.P.
early mobilization
cardiopulmonary rehabilitation
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Group I/Control: Conventional cardiopulmonary rehabilitation will be applied in the postoperative period.
* Group II/ Bottle P.E.P.: Conventional cardiopulmonary rehabilitation and bottle-PEP therapy will be applied in the postoperative period.
* Group III/Early Mobilization: An early mobilization program will be started in conventional cardiopulmonary rehabilitation in the postoperative period.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effects of postoperative early mobilization and Bottle-P.E.P. application on respiratory parameters and functional capacity in patients undergoing heart valve surgery.

Detailed description: After all patients were informed about the study and potential risks, patients who gave informed consent will be evaluated preoperatively and 5-7 days after surgery by the same investigator. Patients will be randomly divided into 3 groups: Group I (n=20, control) - conventional cardiopulmonary rehabilitation, Group II (n=20), conventional cardiopulmonary rehabilitation and Bottle P.E.P. application, Group III (n=20) will be included in the study as conventional cardiopulmonary rehabilitation and early mobilization group. The respiratory parameters of the patients will be determined by a pulmonary function test and their functional capacities will be determined by a 6-minute walk test. The preoperative and postoperative periods will be compared with statistical methods in the light of these evaluations on days 5-7.

Eligibility 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 \&lt;25 or \&gt;75
* Body Mass Index (BMI) ≥ 38 kg/m2
* Intubation time \&gt;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

Primary outcomes:
measure: European System for Cardiac Operative Risk Evaluation (EuroSCORE):
timeFrame: Preoperative period
measure: New York Heart Association (NHYA) Functional Class Assessment:
timeFrame: Preoperative period
measure: Respiratory function test:
timeFrame: Preoperative 1st and 7th days
measure: Baseline transthoracic echocardiography:
timeFrame: Preoperative 1st and 7th days
measure: NT-ProBNP measurement:
timeFrame: Preoperative 1st and 7th days
measure: Functional capacity assessment:
timeFrame: Preoperative 1st and 7th days
measure: The Borg Category-Ratio scale (Borg CR-10) and The Modified Borg Dyspnea Scale (MBS):
timeFrame: Preoperative 1st and 7th days
measure: Functional Independence Measurement (FIM):
timeFrame: Preoperative 1st and 7th days]
measure: Visual Analog Scale - Pain Assessment:
timeFrame: Preoperative 1st and 7th days
Secondary outcomes:
measure: RASS (Richmond Agitation and Sedation Scale):
timeFrame: Postoperative 1st day in intensive care unit
measure: Evaluation of hemodynamic and respiratory parameters:
timeFrame: Postoperative 1st day
measure: Arterial blood gas measurements:
timeFrame: Postoperative 1st day in intensive care unit
measure: Postoperative complication evaluation:
timeFrame: Postoperative 1st and 7th days
measure: Length of hospital stay:
timeFrame: Duration of hospital stay
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Provincial Health Directorate Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital
state: Uskudar
Study officials:
affiliation: Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Rezan Aksoy, Ass Prof Dr
role: STUDY_CHAIR
affiliation: Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Recep Çalışkan, Doctor
role: STUDY_CHAIR
References: