Respiration DisordersNCT05267067
Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery
A study testing respiratory exercises in people with Respiration Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Respiration Disorders
- What is being tested?
- respiratory exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2020to 1 Feb 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male patients
- underwent valve surgery (repair or replacement) for mitral valve stenosis;
- hemodynamically stable,
- ages ranged from 12 to 18 years old-
- BMI ranges from 18.5 to 24.9
- reduced MEP, MVV and complaining from shortness of breath with exertion.
Who cannot join
- Patients with previous cardiac surgery
- congenital heart disease
- neurological disorders
- type1 diabetes mellitus
- smoker
- pacemaker implantation
- atrial fibrillation
- utilization of mechanical ventilation longer than 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter
Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.
Read the detailed description
Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.
- Conditions
- Respiration Disorders
- Being tested
- respiratory exercises
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory exercisesOther
Manual respiratory exercises versus respiratory exercises with pressure meter
| Study group | Role | What they receive |
|---|---|---|
| manual respirtory exercises | Active comparator | Using manual traditional respiratory exercises. Receives: Other: respiratory exercises |
| Respiratory exercises with respiratory pressure meter | Active comparator | Using pressure respiratory meter in exercises. Receives: Other: respiratory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
By respiratory pressure meter
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start2 Sep 2020
- Primary completion20 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Ahmed Abdalbary, Cairo University
- Investigators
- Abdallaha Mohamed, MD, Study chair, Nahda University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267067
- Sponsor's protocol ID
- Chest physiotherapy
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2022
- Last updated
- 4 Mar 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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter
- ClinicalTrials.gov ID
- NCT05267067
- Acronym / sponsor ID
- Chest physiotherapy
- Conditions
- Respiration Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 4 Mar 2022 (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.
Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.
Detailed description
Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual respirtory exercises | Active comparator | Other: respiratory exercisesUsing manual traditional respiratory exercises. |
| Respiratory exercises with respiratory pressure meter | Active comparator | Other: respiratory exercisesUsing pressure respiratory meter in exercises. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male patients
- underwent valve surgery (repair or replacement) for mitral valve stenosis;
- hemodynamically stable,
- ages ranged from 12 to 18 years old-
- BMI ranges from 18.5 to 24.9
Key exclusion criteria (8 listed)
- Patients with previous cardiac surgery
- congenital heart disease
- neurological disorders
- type1 diabetes mellitus
- smoker
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 exercisesManual respiratory exercises versus respiratory exercises with pressure meter | Other | Respiratory exercises with respiratory pressure meter, manual respirtory exercises |
Primary outcome
Respiratory muscle strength
Time frame: 3 month
By respiratory pressure meter
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 4 Mar 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.
Abdallaha Mohamed, MD study chair
Nahda University, Faculty of Physical Therapy
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 exercises in people with Respiration Disorders, 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 6 inclusion and 8 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 4 Mar 2022. 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?
Respiratory muscle strength (time frame: 3 month). 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 4 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.