PhysiotherapyNCT03726541
Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
A study testing physiotherapy in people with Physiotherapy and Postoperative, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Physiotherapy, Postoperative, Lung Diseases
- What is being tested?
- physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-75 age
- Hemodynamically stable
- Being conscious
Who cannot join
- Excessive pain
- Neurological complications
- Posttraumatic and musculoskeletal problems to prevent exercise
- Do not want to be included in the study
- Fever above 38 degrees
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yedikule Chest Disease Hospital
Istanbul, Zeytinburnu, 34200
About this study
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.
- Conditions
- Physiotherapy, Postoperative, Lung Diseases
- Being tested
- physiotherapy
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early physiotherapy group | Experimental | breathing exercise incentive spirometry training ambulation coughing Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline oxygen saturation
The hearth rate response will be measured before and after exercise training with pulse oximeter.
Measured: 30 minutes
Change from baseline hearth rate response.
The hearth rate response will be measured before and after exercise training with intensive care ECG
Measured: 30 minutes
Change from baseline systolic and diastolic blood pressure response.
Blood pressure will be measured before and after exercise training with monometer from the arm
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
- Investigators
- Arif Balcı, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726541
- Sponsor's protocol ID
- Hemodynamics_ physiotherapy
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Physiotherapy in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT03726541
- Acronym / sponsor ID
- Hemodynamics_ physiotherapy
- Conditions
- Physiotherapy, Postoperative, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early physiotherapy group | Experimental | Other: physiotherapybreathing exercise incentive spirometry training ambulation coughing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between 18-75 age
- Hemodynamically stable
- Being conscious
Key exclusion criteria (5 listed)
- Excessive pain
- Neurological complications
- Posttraumatic and musculoskeletal problems to prevent exercise
- Do not want to be included in the study
- Fever above 38 degrees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapyPhysiotherapy 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. | Other | Early physiotherapy group |
Primary outcome
Change from baseline oxygen saturation
Time frame: 30 minutes
The hearth rate response will be measured before and after exercise training with pulse oximeter.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Balcı study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy in people with Physiotherapy and Postoperative, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline oxygen saturation (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.