Cardiopulmonary Rehabilitation In Heart Valve Surgery

Istanbul Saglik Bilimleri University

Status: Enrolling

Conditions: Heart Valve Diseases

Treatments: Other: Bottle P.E.P. (Pozitive Expiratory Pressure); Other: Early Mobilization; Other: Conventional Cardiopulmonary Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06493123

Saglik Bilimleri University

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Group I

Experimental group

Description:

Group I/Control group: Conventional cardiopulmonary rehabilitation will be applied in the postoperative period.

Treatment:

Other: Conventional Cardiopulmonary Rehabilitation

Group II

Experimental group

Description:

Group II/ Bottle P.E.P.: Conventional cardiopulmonary rehabilitation and bottle-PEP therapy will be applied in the postoperative period.

Treatment:

Other: Conventional Cardiopulmonary Rehabilitation

Other: Bottle P.E.P. (Pozitive Expiratory Pressure)

Group III

Experimental group

Description:

Group III/Early Mobilization: Early mobilization program will be started in conventional cardiopulmonary rehabilitation in the postoperative period.

Treatment:

Other: Conventional Cardiopulmonary Rehabilitation

Other: Early Mobilization