Lung Fibrosis InterstitialNCT06191367
Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients
A study testing Aerobic Exercises, Incentive Spirometer Device and Traditional Chest Physiotherapy in people with Lung Fibrosis Interstitial and Post-COVID-19 Syndrome, run by McCarious Nahad Aziz Abdelshaheed Stephens at 1 site in Egypt.
Trial summary
the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Lung Fibrosis Interstitial, Post-COVID-19 Syndrome
- What is being tested?
- Aerobic Exercises, Incentive Spirometer Device and Traditional Chest Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to Feb 2024
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodynamic stable (MAP not less than 60mmHg, systolic pressure >80mmHg and diastolic pressure not <60mmHg)
- Age from 40 to 85 years.
- Both sexes.
- All patients were positive covid-19 infected patients and passed at least 4 weeks after confirmation.
- All patients suffer from respiratory complications.
- All patients included are actively breathing.
- All patients included are fully aware and conscious.
Who cannot join
- Hemodynamic Instability.
- Severe Head Injury.
- Increased intracranial pressure.
- Anemic Hb<8.
- Active Smoking.
- Severe Bronchospasm.
Show all 10Show fewer
- Low BP (systole <80, diastole <60).
- Subcutaneous Emphysema.
- Rip Fractures.
- Untreated Pneumothorax.
Trial locations and contacts
1 site in 1 country.
About this study
the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases.
Read the detailed description
To our knowledge, there have been no enough studies that investigated the effect of aerobic exercise and incentive spirometer in pulmonary rehabilitation on post-covid syndrome patients.
Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.
The finding of this proposed work may help patients with post-covid syndrome and complain of lung diseases by addressing their complains of symptoms like chest pain, dyspnea, and cough and provide a possible solution to enhance their quality of life and increase their participation in daily life activities.
Patients of post-covid syndrome with residual lung problems will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo university. All participants will sign a written informed consent form.
The subjects will be randomly assigned into one of three groups:
- Group I (experimental) will receive aerobic exercises program and traditional chest physiotherapy.
- Group II (experimental) will receive incentive spirometer device treatment and traditional chest physiotherapy.
- Group III (control) will receive traditional chest physiotherapy only. The measures will be taken before and after treatment program.
- Conditions
- Lung Fibrosis Interstitial, Post-COVID-19 Syndrome
- Being tested
- Aerobic Exercises, Incentive Spirometer Device, Traditional Chest Physiotherapy
- Medical subject headings
- Pulmonary Fibrosis, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExercisesOther
Aerobic Exercises
Incentive Spirometer DeviceDevice
is a handheld medical device used to help patients improve the functioning of their lungs. By training patients to take slow and deep breaths, this simplified spirometer facilitates lung expansion and strengthening. Patients inhale through a mouthpiece, which causes a piston inside the device to rise. This visual feedback helps them monitor their inspiratory effort. Incentive spirometers are commonly used after surgery or other illnesses to prevent pulmonary complications.
Traditional Chest PhysiotherapyOther
- Breathing exercise.
- Postural drainage.
- Percussion.
- Coughing.
- Vibration.
| Study group | Role | What they receive |
|---|---|---|
| Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy. | Experimental | It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received aerobic exercise techniques which consist of 3 levels of activity exercises and traditional program of chest physiotherapy. (Five times per week for two months). Receives: Other: Aerobic Exercises; Other: Traditional Chest Physiotherapy |
| Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy. | Experimental | It was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received incentive spirometer training techniques and traditional program of chest physiotherapy. (Five times per week for two months). Receives: Device: Incentive Spirometer Device; Other: Traditional Chest Physiotherapy |
| Group III (control) will receive Traditional Chest Physiotherapy only. | Active comparator | As a control group it was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received traditional program of chest physiotherapy only. (Five times per week for two months).
for example: - Breathing Exercises. - Postural Drainage. - Percussion. - Coughing - Vibration. Receives: Other: Traditional Chest Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function tests (PFTs).
to measure the lungs' capacities and volumes like: FVC, FEV1, and PEF.
Measured: Before and After the treatment program. "8 weeks"
Peripheral oxygen saturation level (SpO2).
measures the amount of oxygen carried in the blood stream in peripheral limbs.
Measured: Before and After the treatment program. "8 weeks"
Six minutes' walk distance test (6MWD).
measures the aerobic capacity of the lungs by testing the maximum distance the subject can walk in a 6 minutes time.
Measured: Before and After the treatment program. "8 weeks"
Heart rate measurements. (HR).
it measures the number of heart bumps in a minute in order to deliver blood to all of the body during Rest and Activity.
Measured: through all the treatment procedures. "8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Feb 2022
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Fibrosis InterstitialStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McCarious Nahad Aziz Abdelshaheed Stephens
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, McCarious Nahad Aziz Abdelshaheed Stephens, Cairo University
- Investigators
- Mohamed H Elgendy, Doctoral, Principal investigator, Physiotherapy Faculty, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191367
- Sponsor's protocol ID
- CairoU post-covid PF Rehab
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercises Versus Incentive Spirometer Device on Post-covid Pulmonary Fibrosis Patients
- ClinicalTrials.gov ID
- NCT06191367
- Acronym / sponsor ID
- CairoU post-covid PF Rehab
- Conditions
- Lung Fibrosis Interstitial, Post-COVID-19 Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- McCarious Nahad Aziz Abdelshaheed StephensUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 5 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.
the aim of this study will be to investigate the effect of aerobic exercises vs incentive spirometer device on post-covid patients with residual lung diseases.
Detailed description
To our knowledge, there have been no enough studies that investigated the effect of aerobic exercise and incentive spirometer in pulmonary rehabilitation on post-covid syndrome patients.
Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.
The finding of this proposed work may help patients with post-covid syndrome and complain of lung diseases by addressing their complains of symptoms like chest pain, dyspnea, and cough and provide a possible solution to enhance their quality of life and increase their participation in daily life activities.
Patients of post-covid syndrome with residual lung problems will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo university. All participants will sign a written informed consent form.
The subjects will be randomly assigned into one of three groups:
- Group I (experimental) will receive aerobic exercises program and traditional chest physiotherapy.
- Group II (experimental) will receive incentive spirometer device treatment and traditional chest physiotherapy.
- Group III (control) will receive traditional chest physiotherapy only. The measures will be taken before and after treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy. | Experimental | Other: Aerobic Exercises, Other: Traditional Chest PhysiotherapyIt was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received aerobic exercise techniques which consist of 3 levels of activity exercises and traditional program of chest physiotherapy. (Five times per week for two months). |
| Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy. | Experimental | Device: Incentive Spirometer Device, Other: Traditional Chest PhysiotherapyIt was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received incentive spirometer training techniques and traditional program of chest physiotherapy. (Five times per week for two months). |
| Group III (control) will receive Traditional Chest Physiotherapy only. | Active comparator | Other: Traditional Chest PhysiotherapyAs a control group it was consisted of fifteen patients with positive covid-19 test from at least a month before trial. They received traditional program of chest physiotherapy only. (Five times per week for two months). for example: - Breathing Exercises. - Postural Drainage. - Percussion. - Coughing - Vibration. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hemodynamic stable (MAP not less than 60mmHg, systolic pressure >80mmHg and diastolic pressure not <60mmHg)
- Age from 40 to 85 years.
- Both sexes.
- All patients were positive covid-19 infected patients and passed at least 4 weeks after confirmation.
- All patients suffer from respiratory complications.
Key exclusion criteria (10 listed)
- Hemodynamic Instability.
- Severe Head Injury.
- Increased intracranial pressure.
- Anemic Hb<8.
- Active Smoking.
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 |
|---|---|---|
| Aerobic ExercisesAerobic Exercises | Other | Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy. |
| Incentive Spirometer Deviceis a handheld medical device used to help patients improve the functioning of their lungs. By training patients to take slow and deep breaths, this simplified spirometer facilitates lung expansion and strengthening. Patients inhale through a mouthpiece, which causes a piston inside the device to rise. This visual feedback helps them monitor their inspiratory effort. Incentive spirometers are commonly used after surgery or other illnesses to prevent pulmonary complications. | Device | Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy. |
| Traditional Chest Physiotherapy1. Breathing exercise. 2. Postural drainage. 3. Percussion. 4. Coughing. 5. Vibration. | Other | Group I (experimental) Aerobic Exercises and Traditional Chest Physiotherapy., Group II (experimental)Incentive Spirometer Device and Traditional Chest Physiotherapy., Group III (control) will receive Traditional Chest Physiotherapy only. |
Primary outcome
Pulmonary function tests (PFTs).
Time frame: Before and After the treatment program. "8 weeks"
to measure the lungs' capacities and volumes like: FVC, FEV1, and PEF.
Peripheral oxygen saturation level (SpO2).
Time frame: Before and After the treatment program. "8 weeks"
measures the amount of oxygen carried in the blood stream in peripheral limbs.
Six minutes' walk distance test (6MWD).
Time frame: Before and After the treatment program. "8 weeks"
measures the aerobic capacity of the lungs by testing the maximum distance the subject can walk in a 6 minutes time.
Heart rate measurements. (HR).
Time frame: through all the treatment procedures. "8 weeks"
it measures the number of heart bumps in a minute in order to deliver blood to all of the body during Rest and Activity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No. 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.
Mohamed H Elgendy, Doctoral principal investigator
Physiotherapy Faculty, 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 Aerobic Exercises, Incentive Spirometer Device and Traditional Chest Physiotherapy in people with Lung Fibrosis Interstitial and Post-COVID-19 Syndrome, run by McCarious Nahad Aziz Abdelshaheed Stephens 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 7 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: status not confirmed, as of the sponsor's last update on 5 Jan 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 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?
Results are not available in the source record.
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?
Pulmonary function tests (PFTs). (time frame: Before and After the treatment program. "8 weeks"). The study lists 4 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 5 Jan 2024.