- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03726541
Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
March 6, 2019 updated by: esra pehlivan, Istanbul Medipol University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey, 34200
- Yedikule Chest Disease Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early physiotherapy group
breathing exercise incentive spirometry training ambulation coughing
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline oxygen saturation
Time Frame: 30 minutes
|
The hearth rate response will be measured before and after exercise training with pulse oximeter.
|
30 minutes
|
|
Change from baseline hearth rate response.
Time Frame: 30 minutes
|
The hearth rate response will be measured before and after exercise training with intensive care ECG
|
30 minutes
|
|
Change from baseline systolic and diastolic blood pressure response.
Time Frame: 30 minutes
|
Blood pressure will be measured before and after exercise training with monometer from the arm
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Arif Balcı, Saglik Bilimleri Universitesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
December 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
October 30, 2018
First Submitted That Met QC Criteria
October 30, 2018
First Posted (Actual)
October 31, 2018
Study Record Updates
Last Update Posted (Actual)
March 7, 2019
Last Update Submitted That Met QC Criteria
March 6, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hemodynamics_ physiotherapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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