Heart Valve DiseasesNCT06012474
Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
A study testing Power breath plus, Incrementing the training load and Diaphragmatic breathing exercises in people with Heart Valve Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Power breath plus, Incrementing the training load and Diaphragmatic breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 15 Oct 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients with valve surgery (valve replacement or repair with median sternotomy procedure).
- Age between 25 to 35 years old.
- BMI is between 18.5 to 24.5 kg/m2.
Who cannot join
- The participants will be excluded if they meet one of the following criteria:
- Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg)
- Patients with coronary artery disease or heart failure.
- Need for mechanical ventilation for >24 h or reintubation.
- Renal and hepatic disorders.
- Infected or unstable sternum.
Show all 12Show fewer
- patient with pneumothorax after surgery.
- Metabolic disorders.
- Pregnant woman.
- Lactating mother.
- Smokers
- Stroke patient
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic faculty of physical therapy cairo university
Dokki
About this study
The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.
Read the detailed description
No more studies have been done on the effect of IMT by power breath on valvular surgery, So, this study will see the effect of power breath device on arterial blood gases, diaphragmatic excursion and six minute walk test after valve surgery to know enhanced recovery protocols in valvular surgery that accelerate the functional recovery, minimize the length of the hospital stay and decrease cost of treatment.
- Conditions
- Heart Valve Diseases
- Being tested
- Power breath plus, Incrementing the training load, Diaphragmatic breathing exercises
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power breath plusOther
Power breath plus use a variable load calibrated spring. It can be adjusted from the lowest load setting (17cmH2O) when training began and increased as the patient breathing muscles adapt and become stronger (maximum load setting 274cmH2O). Use a comfortable chair, preferably straight-back so that the spine is straight at all times during the exercise. patients will be instructed to exhale calmly, followed by a maximal forced inspiration to total lung capacity using a mouthpiece and a nasal clip as an aid to prevent air leaks and will ask to make 10 breaths for 3 sets once daily for 7 days with 2min rest between sets
Incrementing the training loadOther
The resistance will be increased incrementally, based on the rate of perceived exertion (RPE) scored by the patient on the modified Borg Scale. If the RPE is less than 5, the resistance of the inspiratory trainer will be increased incrementally by 2cmH2O. The resistance will not change if the level of perceived exertion is rated from 6 to 8, and the resistance will be decreased by 1 to 2 cmH2O if the level of perceived exertion is rated 9 or 10.
Diaphragmatic breathing exercisesOther
Training by using incentive spirometer:
- Loosen any tight clothing, especially around neck.
- Each patient will be instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer.
- The patient will be instructed to exhale letting all the breath out.
- patient will asked to close the lips around the mouthpiece of the spirometer.
- patient will be instructed to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column.
- patient will be asked to hold the breath as long as possible (at least five seconds) then exhale slowly.
- Session will be in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets.
- Intensity of exercise will be increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status.
| Study group | Role | What they receive |
|---|---|---|
| inspiratory muscle training group | Experimental | 30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days. Receives: Other: Power breath plus; Other: Incrementing the training load |
| diaphragmatic breathing exercise group | Active comparator | 20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days. Receives: Other: Diaphragmatic breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in diaphragmatic excursion
By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.
Measured: within 24 hours after 1 week of intervention
Assessing the change in Arterial Blood gases
Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.
Measured: within 24 hours after 1 week of intervention
Assessing the change in capacity to perform daily activities
by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).
Measured: within 24 hours after 1 week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jan 2022
- Primary completion15 May 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mahdy Hassan Mohamed, Cairo University
- Investigators
- Hend Mahdy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012474
- Sponsor's protocol ID
- 012/004209
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
- ClinicalTrials.gov ID
- NCT06012474
- Acronym / sponsor ID
- 012/004209
- Conditions
- Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 25 Aug 2023 (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.
The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.
Detailed description
No more studies have been done on the effect of IMT by power breath on valvular surgery, So, this study will see the effect of power breath device on arterial blood gases, diaphragmatic excursion and six minute walk test after valve surgery to know enhanced recovery protocols in valvular surgery that accelerate the functional recovery, minimize the length of the hospital stay and decrease cost of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inspiratory muscle training group | Experimental | Other: Power breath plus, Other: Incrementing the training load30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days. |
| diaphragmatic breathing exercise group | Active comparator | Other: Diaphragmatic breathing exercises20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients with valve surgery (valve replacement or repair with median sternotomy procedure).
- Age between 25 to 35 years old.
- BMI is between 18.5 to 24.5 kg/m2.
Key exclusion criteria (12 listed)
- Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg)
- Patients with coronary artery disease or heart failure.
- Need for mechanical ventilation for >24 h or reintubation.
- Renal and hepatic disorders.
- Infected or unstable sternum.
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 |
|---|---|---|
| Power breath plusPower breath plus use a variable load calibrated spring. It can be adjusted from the lowest load setting (17cmH2O) when training began and increased as the patient breathing muscles adapt and become stronger (maximum load setting 274cmH2O). Use a comfortable chair, preferably straight-back so that the spine is straight at all times during the exercise. patients will be instructed to exhale calmly, followed by a maximal forced inspiration to total lung capacity using a mouthpiece and a nasal clip as an aid to prevent air leaks and will ask to make 10 breaths for 3 sets once daily for 7 days with 2min rest between sets | Other | inspiratory muscle training group |
| Incrementing the training loadThe resistance will be increased incrementally, based on the rate of perceived exertion (RPE) scored by the patient on the modified Borg Scale. If the RPE is less than 5, the resistance of the inspiratory trainer will be increased incrementally by 2cmH2O. The resistance will not change if the level of perceived exertion is rated from 6 to 8, and the resistance will be decreased by 1 to 2 cmH2O if the level of perceived exertion is rated 9 or 10. | Other | inspiratory muscle training group |
| Diaphragmatic breathing exercisesTraining by using incentive spirometer: * Loosen any tight clothing, especially around neck. * Each patient will be instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer. * The patient will be instructed to exhale letting all the breath out. * patient will asked to close the lips around the mouthpiece of the spirometer. * patient will be instructed to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column. * patient will be asked to hold the breath as long as possible (at least five seconds) then exhale slowly. * Session will be in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets. * Intensity of exercise will be increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status. | Other | diaphragmatic breathing exercise group |
Primary outcome
Assessing the change in diaphragmatic excursion
Time frame: within 24 hours after 1 week of intervention
By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.
Assessing the change in Arterial Blood gases
Time frame: within 24 hours after 1 week of intervention
Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.
Assessing the change in capacity to perform daily activities
Time frame: within 24 hours after 1 week of intervention
by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).
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 25 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Hend Mahdy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power breath plus, Incrementing the training load and Diaphragmatic breathing exercises in people with Heart Valve Diseases, run by Cairo University at 1 site in Egypt.
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 12 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 25 Aug 2023. 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 Egypt. 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?
Assessing the change in diaphragmatic excursion (time frame: within 24 hours after 1 week of intervention). 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 25 Aug 2023.