Cardiopulmonary Rehabilitation In Heart Valve Surgery

NCT06493123 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-05-22

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06493123 on ClinicalTrials.gov