Rib FracturesNCT06222333
Breathing Exercise for Rib Fracture
A study testing Respiratory physiotherapy and Conservative Treatment in people with Rib Fractures and Spirometry, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rib Fractures, Spirometry
- What is being tested?
- Respiratory physiotherapy and Conservative Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated thoracic injury within 24 hours
- Age between 18-100
Who cannot join
- Pneumothorax and hemothorax requiring intervention at admission
- Injury severity index >16
- COPD, Atshma
- Extrathoracic trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kastamonu University
Kastamonu, 37150
About this study
Official title: Can Breathing Exercise Reduce Pulmonary Complications in Rib Fractures: Randomized Prospective Study
Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. In our study, patients with rib fractures will be divided into two groups. In the control group, standard treatment consisting of routine analgesic treatments will be applied. In the other group, respiratory physiotherapy will be applied with triflu for 8 hours a day. At the end of the study, pulmonary complications in both groups will be compared.
Read the detailed description
Patients between the ages of 18 and 100 who will apply to our hospital due to rib fractures between April 2024 and April 2025 will be evaluated. Patients who meet the inclusion criteria will be included in the study. Patients will be divided into two groups using randomization blocks. Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. In the other group of patients, in addition to conservative treatment, triflow breathing exercise will be applied for 8 hours a day. Respiratory function test pain scores and pulmonary complications of patients in the two groups will be compared statistically.
- Conditions
- Rib Fractures, Spirometry
- Being tested
- Respiratory physiotherapy, Conservative Treatment
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory physiotherapyBehavioural
Also called Triflow
In this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour.
Conservative TreatmentDrug
Also called Control
Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory physiotherapy group | Experimental | In this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour Receives: Behavioral: Respiratory physiotherapy |
| Routine treatment group | Active comparator | Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. Receives: Drug: Conservative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1, FVC, FEV1/FVC results on day 7
FEV1, FVC, FEV1/FVC
Measured: 7 days
Secondary outcomes (2)
Number of Participants with Pneumonia
Clinical and radiological diagnosis of pneumonia
Measured: 7 days
FEV1, FVC, FEV1/FVC results on day 2
FEV1, FVC, FEV1/FVC
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start13 Nov 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail DAL, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222333
- Sponsor's protocol ID
- KastamonuU1
- Status last verified
- Nov 2024
- First submitted
- 3 Jan 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Breathing Exercise Reduce Pulmonary Complications in Rib Fractures: Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT06222333
- Acronym / sponsor ID
- KastamonuU1
- Conditions
- Rib Fractures, Spirometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 24 Jan 2024 (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.
Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. In our study, patients with rib fractures will be divided into two groups. In the control group, standard treatment consisting of routine analgesic treatments will be applied. In the other group, respiratory physiotherapy will be applied with triflu for 8 hours a day. At the end of the study, pulmonary complications in both groups will be compared.
Detailed description
Patients between the ages of 18 and 100 who will apply to our hospital due to rib fractures between April 2024 and April 2025 will be evaluated. Patients who meet the inclusion criteria will be included in the study. Patients will be divided into two groups using randomization blocks. Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. In the other group of patients, in addition to conservative treatment, triflow breathing exercise will be applied for 8 hours a day. Respiratory function test pain scores and pulmonary complications of patients in the two groups will be compared statistically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory physiotherapy group | Experimental | Behavioral: Respiratory physiotherapyIn this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour |
| Routine treatment group | Active comparator | Drug: Conservative TreatmentPatients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Isolated thoracic injury within 24 hours
- Age between 18-100
Key exclusion criteria (4 listed)
- Pneumothorax and hemothorax requiring intervention at admission
- Injury severity index >16
- COPD, Atshma
- Extrathoracic trauma
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 |
|---|---|---|
| Respiratory physiotherapyAlso: TriflowIn this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour. | Behavioural | Respiratory physiotherapy group |
| Conservative TreatmentAlso: ControlPatients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. | Drug | Routine treatment group |
Primary outcome
FEV1, FVC, FEV1/FVC results on day 7
Time frame: 7 days
FEV1, FVC, FEV1/FVC
2 secondary outcomes
Number of Participants with Pneumonia
Time frame: 7 days
FEV1, FVC, FEV1/FVC results on day 2
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Yes. Yes
Related trials for Rib Fractures
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Recruiting
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures
Discitis of Thoracic Region
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory physiotherapy and Conservative Treatment in people with Rib Fractures and Spirometry, run by Kastamonu University 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İsmail Dal, MD (+905446533224, drismaildal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1, FVC, FEV1/FVC results on day 7 (time frame: 7 days). 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 14 Nov 2024.