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Hemodynamic Effects of Physiotherapy in the Early Postoperative Period

Primary Purpose

Physiotherapy, Postoperative, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
physiotherapy
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Physiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Between 18-75 age
  • Hemodynamically stable
  • Being conscious

Exclusion Criteria:

  • Excessive pain
  • Neurological complications
  • Posttraumatic and musculoskeletal problems to prevent exercise
  • Do not want to be included in the study
  • Fever above 38 degrees

Sites / Locations

  • Yedikule Chest Disease Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early physiotherapy group

Arm Description

breathing exercise incentive spirometry training ambulation coughing

Outcomes

Primary Outcome Measures

Change from baseline oxygen saturation
The hearth rate response will be measured before and after exercise training with pulse oximeter.
Change from baseline hearth rate response.
The hearth rate response will be measured before and after exercise training with intensive care ECG
Change from baseline systolic and diastolic blood pressure response.
Blood pressure will be measured before and after exercise training with monometer from the arm

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
March 6, 2019
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03726541
Brief Title
Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
Official Title
Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Physiotherapy will be applied to the patients who undergo thoracotomy operation after 24 hours of intensive care stay. Physiotherapy program includes breathing exercises, incentive spirometer training, ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the training session. Changes in the follow-up parameters will be discussed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiotherapy, Postoperative, Lung Diseases

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early physiotherapy group
Arm Type
Experimental
Arm Description
breathing exercise incentive spirometry training ambulation coughing
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
Physiotherapy program includes breathing exercises, incisive spirometer study, grade ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the session. Changes in the follow-up parameters will be discussed.
Primary Outcome Measure Information:
Title
Change from baseline oxygen saturation
Description
The hearth rate response will be measured before and after exercise training with pulse oximeter.
Time Frame
30 minutes
Title
Change from baseline hearth rate response.
Description
The hearth rate response will be measured before and after exercise training with intensive care ECG
Time Frame
30 minutes
Title
Change from baseline systolic and diastolic blood pressure response.
Description
Blood pressure will be measured before and after exercise training with monometer from the arm
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Between 18-75 age Hemodynamically stable Being conscious Exclusion Criteria: Excessive pain Neurological complications Posttraumatic and musculoskeletal problems to prevent exercise Do not want to be included in the study Fever above 38 degrees
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arif Balcı
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Yedikule Chest Disease Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hemodynamic Effects of Physiotherapy in the Early Postoperative Period

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