COPD ExacerbationNCT04170361
The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation
A study testing Conventional Chest Physiotherapy and Conventional Chest Physiotherapy+Incentive Spirometry in people with COPD Exacerbation, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
COPD; it is a common, preventable and treatable disease that is associated with increased chronic inflammatory responses in the airways and lungs against harmful gases and particles, and that it manages progressive airflow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Conventional Chest Physiotherapy and Conventional Chest Physiotherapy+Incentive Spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Sep 2021to 22 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with COPD exacerbation
- Hemodynamically stable
- To be conscious and voluntarily agree to participate in the study
Who cannot join
- Existence of neurological, cardiovascular and musculoskeletal problems to prevent exercise
- Having chronic respiratory disease other than COPD
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Meltem Kaya
Istanbul, 34050
Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation
Istanbul
About this study
COPD; it is a common, preventable and treatable disease that is associated with increased chronic inflammatory responses in the airways and lungs against harmful gases and particles, and that it manages progressive airflow. The definition of exacerbation is defined as an acute onset with a change in where daily differences in the main symptoms occur and which may occur with the presence of drugs. The number of exacerbations in the course of the disease is between 1-3 years on average. Routine physiotherapy treatment in COPD exacerbation is expected to increase lung volume and effective removal of airway secretions. The concept of physiotherapy programs is vibration, thoracic expression exercise, positive expiratory pressure therapy and gait programs.
An incentive spirometer is a simple, inexpensive device to adjust lung tissue re-expansion by increasing lung volumes and diaphragmatic mobility, providing maximal inspiration with termination control without a resistive loading. In COPD patients, the use of incentive spirometry is to increase alveolar ventilation and oxygenation in lifestyle.
There are a limited number of studies in the literature regarding the results of the use of incentive spirometry in COPD patients. The results of postoperative results of incentive spirometry in COPD patients were tried and established on pulmonary complications, diseases, postoperative dyspnea perception and lifestyle. The importance of the investigator's research; this is the first study to evaluate hemodynamic responses and hospitalization plans of incentive spirometer and routine physiotherapy program in COPD exacerbations.
- Conditions
- COPD Exacerbation
- Being tested
- Conventional Chest Physiotherapy, Conventional Chest Physiotherapy+Incentive Spirometry
- Keywords
- COPD, incentive spirometry, length of stay, hemodynamic responses
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest PhysiotherapyOther
All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.
Conventional Chest Physiotherapy+Incentive SpirometryOther
All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients will be admitted to chest physiotherapy program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. Receives: Other: Conventional Chest Physiotherapy |
| Training Group | Experimental | In addition to conventional chest physiotherapy program, patients in this group will also be taught to use Triflo ® and apply at two-hour intervals. Receives: Other: Conventional Chest Physiotherapy; Other: Conventional Chest Physiotherapy+Incentive Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
The oxygen saturation response will be measured before and after physiotherapy program with pulse oximeter.
Measured: 30 minutes
Heart rate
The hearth rate response will be measured before and after after physiotherapy program with pulse oximeter.
Measured: 30 minutes
Systolic and diastolic blood pressure
Blood pressure will be measured before and after physiotherapy program with monometer from the arm
Measured: 30 minutes
Respiratory rate
Blood pressure will be measured before and after physiotherapy program with observation
Measured: 30 minutes
Forced Vital Capacity (FVC)
FVC will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: 30 minutes
Forced Expiratory Volume in 1 second (FEV1)
FEV1 will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: 30 minutes
Peak Expiratory Flow (PEF)
PEF will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Measured: 30 minutes
Forced Expiratory Volume 25-75%
FEF 25-75% will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
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 posted20 Nov 2019
- Study start21 Sep 2021
- Primary completion1 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meltem Kaya, PT, PhD(c), Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170361
- Sponsor's protocol ID
- bvumkaya02
- Status last verified
- Apr 2022
- First submitted
- 18 Nov 2019
- Last updated
- 15 Apr 2022
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Incentive Spirometry Added to Routine Physiotherapy Program on Hemodynamic Responses and Hospital Stay in Patients With COPD Exacerbation
- ClinicalTrials.gov ID
- NCT04170361
- Acronym / sponsor ID
- bvumkaya02
- Conditions
- COPD Exacerbation
- Keywords
- COPD, incentive spirometry, length of stay, hemodynamic responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 20 Nov 2019 (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.
COPD; it is a common, preventable and treatable disease that is associated with increased chronic inflammatory responses in the airways and lungs against harmful gases and particles, and that it manages progressive airflow. The definition of exacerbation is defined as an acute onset with a change in where daily differences in the main symptoms occur and which may occur with the presence of drugs. The number of exacerbations in the course of the disease is between 1-3 years on average. Routine physiotherapy treatment in COPD exacerbation is expected to increase lung volume and effective removal of airway secretions. The concept of physiotherapy programs is vibration, thoracic expression exercise, positive expiratory pressure therapy and gait programs.
An incentive spirometer is a simple, inexpensive device to adjust lung tissue re-expansion by increasing lung volumes and diaphragmatic mobility, providing maximal inspiration with termination control without a resistive loading. In COPD patients, the use of incentive spirometry is to increase alveolar ventilation and oxygenation in lifestyle.
There are a limited number of studies in the literature regarding the results of the use of incentive spirometry in COPD patients. The results of postoperative results of incentive spirometry in COPD patients were tried and established on pulmonary complications, diseases, postoperative dyspnea perception and lifestyle. The importance of the investigator's research; this is the first study to evaluate hemodynamic responses and hospitalization plans of incentive spirometer and routine physiotherapy program in COPD exacerbations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Chest PhysiotherapyPatients will be admitted to chest physiotherapy program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. |
| Training Group | Experimental | Other: Conventional Chest Physiotherapy, Other: Conventional Chest Physiotherapy+Incentive SpirometryIn addition to conventional chest physiotherapy program, patients in this group will also be taught to use Triflo ® and apply at two-hour intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with COPD exacerbation
- Hemodynamically stable
- To be conscious and voluntarily agree to participate in the study
Key exclusion criteria (2 listed)
- Existence of neurological, cardiovascular and musculoskeletal problems to prevent exercise
- Having chronic respiratory disease other than COPD
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 |
|---|---|---|
| Conventional Chest PhysiotherapyAll patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis. | Other | Control Group, Training Group |
| Conventional Chest Physiotherapy+Incentive SpirometryAll patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. | Other | Training Group |
Primary outcome
Oxygen saturation
Time frame: 30 minutes
The oxygen saturation response will be measured before and after physiotherapy program with pulse oximeter.
Heart rate
Time frame: 30 minutes
The hearth rate response will be measured before and after after physiotherapy program with pulse oximeter.
Systolic and diastolic blood pressure
Time frame: 30 minutes
Blood pressure will be measured before and after physiotherapy program with monometer from the arm
Respiratory rate
Time frame: 30 minutes
Blood pressure will be measured before and after physiotherapy program with observation
Forced Vital Capacity (FVC)
Time frame: 30 minutes
FVC will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 30 minutes
FEV1 will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Peak Expiratory Flow (PEF)
Time frame: 30 minutes
PEF will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
Forced Expiratory Volume 25-75%
Time frame: 30 minutes
FEF 25-75% will be measured using MIR brand SPIRODOC model portable spirometer and expressed as the percentage of the predicted value according to the guideline of European Respiratory Society (ERS)
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 15 Apr 2022.
- 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.
Meltem Kaya, PT, PhD(c) principal investigator
Bezmialem Vakif University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Chest Physiotherapy and Conventional Chest Physiotherapy+Incentive Spirometry in people with COPD Exacerbation, run by Bezmialem Vakif University at 2 sites 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 2 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 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Oxygen saturation (time frame: 30 minutes). The study lists 8 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 15 Apr 2022.