Cardiopulmonary Rehabilitation In Heart Valve Surgery
NCT06493123 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2026-05-22
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.
Conditions
- Heart Valve Diseases
Interventions
- OTHER
-
Conventional Cardiopulmonary Rehabilitation
Conventional cardiopulmonary applications including positioning, chest physiotherapy, in-bed normal joint movement exercises, sitting and walking, posture exercises
- OTHER
-
Bottle 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.
- OTHER
-
Early 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)
Sponsors & Collaborators
-
Istanbul Saglik Bilimleri University
lead OTHER
Principal Investigators
-
Rezan Aksoy, Ass Prof Dr · Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
-
Recep Çalışkan, Doctor · Istanbul Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-29
- Primary Completion
- 2025-01-29
- Completion
- 2025-01-29
Countries
- Turkey (Türkiye)
Study Locations
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