- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03992235
Importance of Exercise Educational Materials in Chest Physiotherapy
September 27, 2023 updated by: esra pehlivan, Istanbul Medipol University Hospital
The patients who have undergone thoracotomy operation will include in the study.
All patients have chest physiotherapy in the intensive care unit.
Patients will be randomized and divided into two groups.
One group will be given an exercise form with details and photographs of the exercises.
No documents will be given to the other group.
The program includes breathing exercises, incentive spirometry study, coughing and graded ambulation.
After 1 intensive care session, patients are admitted to the service rooms due to routine procedures.
The patients will be served in the afternoon and will be questioned whether they are performing their exercises or not.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
- Physiotherapy will be applied to patients undergoing thoracotomy after 24 hours of intensive care hospitalization.
- Patients will be randomized and divided into two groups. Study group will be given exercise form. Control group not.
- Physiotherapy program includes breathing exercises, incentive spirometry study, graded ambulation and both groups will receive this physiotherapy session in the intensive care unit..
- After the patients are admitted to the service rooms, a service visit will be performed, the amount of remembering of the exercises and whether the exercises are performed in a proper form will be questioned.
Study Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Esra PEHLİVAN
- Phone Number: 2828 +90 212 409 02 00
- Email: fztesrakambur@yahoo.com
Study Contact Backup
- Name: Arif Balcı, PT
- Phone Number: 2828 +90 212 409 02 00
- Email: arifbalci2000@yahoo.com
Study Locations
-
-
Zeytinburnu
-
Istanbul, Zeytinburnu, Turkey, 34200
- Yedikule Chest Disease Hospital
-
Contact:
- Esra Pehlivan
- Phone Number: +902124090200
- Email: fztesrakambur@yahoo.com
-
-
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
Description
Inclusion Criteria:
- Between 18-70 years
- Having undergone post-thoracotomy
- Hemodynamically stable,
- To be conscious
Exclusion Criteria:
- Excessive pain
- Neurological complications
- Cardiovascular and musculoskeletal problems that prevent him from exercising
- Not wanting to be involved 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Chest physiotherapy + educational material
|
All patients will receive chest physiotherapy including "Breathing exercise, intensive spirometry use, coughing, ambulation".
Exercise brochure with photos and explanations
|
|
Other: Control group
Chest physiotherapy
|
All patients will receive chest physiotherapy including "Breathing exercise, intensive spirometry use, coughing, ambulation".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of exercises remembered
Time Frame: 15 second
|
The number of remembered exercises will be asked by the patient to show the exercises and recorded by the physiotherapist.
|
15 second
|
|
The number of exercises done correctly
Time Frame: 15 second
|
The number of exercises done correctly will be asked by the patient to show the exercises and recorded by the physiotherapist.
|
15 second
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic features
Time Frame: 5 second
|
Patients demographic features will be ask to patient
|
5 second
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ESRA PEHLİVAN, PhD, SBÜ
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 (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
June 18, 2019
First Submitted That Met QC Criteria
June 18, 2019
First Posted (Actual)
June 20, 2019
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Educational material
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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