Corona Virus InfectionNCT05787275
Effect of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid-19 Syndrome.
A study testing diaphragmatic positioning and incentive spirometer in people with Corona Virus Infection, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this work is to study the incidence of diaphragmatic dysfunction after COVID 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- diaphragmatic positioning and incentive spirometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 2 Feb 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female above 18 years old
- history of probable or confirmed SARS-CoV-2 infection 3 months from the onset of symptoms or at least 2 months from the end of symptoms .
Who cannot join
- Subjects under 18.
- Patients known to have chronic lung disease .
- Patients known to have neuromuscular disorder.
- Patients known to have diaphragmatic hernia.
- Patients known to have malignancy.
- Patients with clinical evidence of phrenic nerve injury.
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- Patients with recent abdominal or thoracic surgery,
- Patients with history of traumatic lesion possibly affecting diaphragm.
- Subjects with severe malnutrition.
- Patients with BMI more than 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Types of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid Syndrome. A Randomized Control Trail
The aim of this work is to study the incidence of diaphragmatic dysfunction after COVID 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function.
- Conditions
- Corona Virus Infection
- Being tested
- diaphragmatic positioning, incentive spirometer, Control
- Keywords
- Diaphragmatic function, Post Covid, Exercises
- Medical subject headings
- Coronavirus Infections, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic positioningOther
Traditional medical treatment plus diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak
incentive spirometerOther
Traditional medical treatment plus diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak
ControlOther
Traditional medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | received, traditional medical treatment and no exercise Receives: Other: Control |
| diaphragmatic positioning group | Experimental | received diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak Receives: Other: diaphragmatic positioning |
| incentive spirometer group | Experimental | received diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak Receives: Other: incentive spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickness
Measured by ultrasonography
Measured: 6 weeks
Pulmonary Function Test
MVV
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Oct 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Ibrahim Abo Elyazed, Beni-Suef University
- Investigators
- Tamer Abo Elyazed, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787275
- Sponsor's protocol ID
- BeniSuefU3
- Status last verified
- Mar 2023
- First submitted
- 25 Feb 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Types of Diaphragmatic Strengthening Exercises on Diaphragm Muscle Function in Patients With Post Covid Syndrome. A Randomized Control Trail
- ClinicalTrials.gov ID
- NCT05787275
- Acronym / sponsor ID
- BeniSuefU3
- Conditions
- Corona Virus Infection
- Keywords
- Diaphragmatic function, Post Covid, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 28 Mar 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 work is to study the incidence of diaphragmatic dysfunction after COVID 19 infection and the efficacy of different types of diaphragmatic strengthening exercises on diaphragm muscle function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Controlreceived, traditional medical treatment and no exercise |
| diaphragmatic positioning group | Experimental | Other: diaphragmatic positioningreceived diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak |
| incentive spirometer group | Experimental | Other: incentive spirometerreceived diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female above 18 years old
- history of probable or confirmed SARS-CoV-2 infection 3 months from the onset of symptoms or at least 2 months from the end of symptoms .
Key exclusion criteria (10 listed)
- Subjects under 18.
- Patients known to have chronic lung disease .
- Patients known to have neuromuscular disorder.
- Patients known to have diaphragmatic hernia.
- Patients known to have malignancy.
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 |
|---|---|---|
| diaphragmatic positioningTraditional medical treatment plus diaphragmatic strengthening exercises through patient self-positioning in prone on elbows then do diaphragmatic breathing 10-15 min ,twice/day, 7days/ weak | Other | diaphragmatic positioning group |
| incentive spirometerTraditional medical treatment plus diaphragmatic strengthening exercises through using of incentive spirometer 10-15 min ,twice/day, 7days/ weak | Other | incentive spirometer group |
| ControlTraditional medical treatment | Other | Control |
Primary outcome
Diaphragmatic thickness
Time frame: 6 weeks
Measured by ultrasonography
Pulmonary Function Test
Time frame: 6 weeks
MVV
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 28 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
Tamer Abo Elyazed principal investigator
Beni-Suef 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 diaphragmatic positioning and incentive spirometer in people with Corona Virus Infection, run by Beni-Suef 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 2 inclusion and 10 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 28 Mar 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?
Diaphragmatic thickness (time frame: 6 weeks). The study lists 2 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 28 Mar 2023.