RecruitingNot ApplicableNCT06493123

Cardiopulmonary Rehabilitation In Heart Valve Surgery

"Postoperative Mobilization and Bottle-P.E.P. in Heart Valve Surgery:A Prospective Randomized Controlled Study "


Sponsor

Istanbul Saglik Bilimleri University

Enrollment

60 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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

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Interventions

OTHERConventional Cardiopulmonary Rehabilitation

Conventional cardiopulmonary applications including positioning, chest physiotherapy, in-bed normal joint movement exercises, sitting and walking, posture exercises

OTHERBottle P.E.P. (Pozitive Expiratory Pressure)

The device will be built according to the optimal design parameters for a positive expiratory pressure therapy bottle device established by Mestriner et al. According to this Bottle-P.E.P. device: * PEP: 10-20 cmH2O * Inspiration: Expiration Ratio: 1:3-4 * Material Used: Open top plastic bottle, plastic pipe. Plastic Bottle Specifications: I. Material-Hard Plastic II. Dimensions-Weight- 40grams; Height- 25cm; Width- 10cm; Perimeter- 20cm III. Water column height- 13cm Plastic Pipe Properties: I. Material-Pipette II. Inner Diameter- ≥8mm III. Pipe Length- 30cm IV. Depth in the water column - 10cm; 3 cm above the bottom of the bottle surface. \- The distal end of the tube used in the Bottle P.E.P. will be placed 10 cm below the surface, i.e. 10 cm water column and 3 cm above the bottom of the bottle, and the device will be placed on a table in front of the participant.

OTHEREarly Mobilization

The Maebashi mobilization protocol will be followed for early mobilization program. According to this protocol, the hemodynamic and respiratory parameters of the patient will be evaluated first and the patient who meets the criteria for the mobilization program will be started to the mobilization program according to the appropriate stage of the 5-stage mobilization protocol. In Maebashi Mobilization protocol: Level 1: No mobilization and in-bed passive exercise Level 2: Supported in-bed sitting and in-bed active/assistive-active exercise Level 3: Unassisted sitting on the edge of the bed Level 4: Active transfer to chair Level 5: Standing, stepping in place and supported walking about 10 meters (with support of 2 people)


Locations(1)

Istanbul Provincial Health Directorate Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

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NCT06493123


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