Post Covid-19 PatientsNCT05491876
Active Cycle Of Breathing Technique Verses Breathing Exercises In Post ICU COVID-19 Patients
A study testing Chest physiotherapy with breathing exercises and ACBT and Chest physiotherapy with breathing exercises in people with Post Covid-19 Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Covid-19 Patients
- What is being tested?
- Chest physiotherapy with breathing exercises and ACBT and Chest physiotherapy with breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2021to 20 Jul 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
- Adult population
- Age limit 18 -50
- All patients positive with confirmed COVID-19 by polymerase chain reaction (PCR) test and chest computed tomography scan (CT-scan)
Who cannot join
- The patient cannot take part in the trial if they have any kind of muscular-skeletal issue.
- COVID-19-related intubation history
- A clear clinical mental or cognitive disability of any kind.
- Patient on ventilator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Active Cycle Of Breathing Technique And Breathing Exercises On Oxygen Saturation And Pulmonary Function Test In Post ICU COVID-19 Patients
The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Group A got chest physiotherapy with breathing exercises and ACBT whereas Group B got chest physiotherapy with breathing exercises. The treatment took 15-30 minutes and consisted of one session per day, treatment was given 6 days a week for up to 2 weeks and examined by using SPSS 22.
Read the detailed description
The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Group A got chest physiotherapy with breathing exercises and ACBT whereas Group B got chest physiotherapy with breathing exercises. The treatment took 15-30 minutes and consisted of one session per day, treatment was given 6 days a week for up to 2 weeks and examined by using SPSS 22.
- Conditions
- Post Covid-19 Patients
- Being tested
- Chest physiotherapy with breathing exercises and ACBT, Chest physiotherapy with breathing exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapy with breathing exercises and ACBTOther
Also called ACTIVE CYCLE OF BREATHING TECHNIQUE (ACBT)
Group A got chest physiotherapy with breathing exercises and ACBT
Chest physiotherapy with breathing exercisesOther
Group B got chest physiotherapy with breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Chest physiotherapy with breathing exercises and ACBT | Experimental | Group A will recieve chest physiotherapy with breathing exercises and ACBT. Receives: Other: Chest physiotherapy with breathing exercises and ACBT |
| Chest physiotherapy with breathing exercises | Experimental | Group B will receive chest physiotherapy with breathing exercises. Receives: Other: Chest physiotherapy with breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPIROMETRY
Spirometry is a simple test used to help diagnose and monitor certain lung conditions by measuring how much air you can breathe out in one forced breath. In a spirometry test, while you are sitting, you breathe into a mouthpiece that is connected to an instrument called a spirometer. The spirometer records the amount and the rate of air that you breathe in and out over a period of time. When standing, some numbers might be slightly different.
Measured: 4 weeks
PULSE OXIMETRY
pulse oximetry is a painless, noninvasive method of measuring the saturation of oxygen in a person's blood. Oxygen saturation is a crucial measure of how well the lungs are working. When we breathe in air, our lungs transmit oxygen into tiny blood vessels called capillaries. A normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%. If you have a lung disease such as COPD or pneumonia, your normal oxygen saturation level may be lower.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start15 Sep 2021
- Primary completion10 Feb 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Covid-19 PatientsStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Model description
- The study came to the conclusion that both techniques, breathing exercises with and without ACBT were beneficial in raising PaO2, FEV1, FVC, and the FEV1/FVC ratio as well as oxygen saturation. However, based on their mean differences, ACBT with breathing exercises was more beneficial in terms of the indicated end measures.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, MS.CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491876
- Sponsor's protocol ID
- REC/RCR & AHS/22/0333
- Status last verified
- Jun 2024
- First submitted
- 24 Jul 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gastaldi AC, Paredi P, Talwar A, Meah S, Barnes PJ, Usmani OS. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.
PubMed 26496331van Mourik Y, Rutten FH, Bertens LCM, Cramer MJM, Lammers JJ, Gohar A, Reitsma JB, Moons KGM, Hoes AW. Clinical research study implementation of case-finding strategies for heart failure and chronic obstructive pulmonary disease in the elderly with reduced exercise tolerance or dyspnea: A cluster randomized trial. Am Heart J. 2020 Feb;220:73-81. doi: 10.1016/j.ahj.2019.08.021. Epub 2019 Sep 1.
PubMed 31790904Gephine S, Mucci P, Grosbois JM, Maltais F, Saey D. Physical Frailty in COPD Patients with Chronic Respiratory Failure. Int J Chron Obstruct Pulmon Dis. 2021 May 17;16:1381-1392. doi: 10.2147/COPD.S295885. eCollection 2021.
PubMed 34045852
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Active Cycle Of Breathing Technique And Breathing Exercises On Oxygen Saturation And Pulmonary Function Test In Post ICU COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05491876
- Acronym / sponsor ID
- REC/RCR & AHS/22/0333
- Conditions
- Post Covid-19 Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 8 Aug 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.
The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Group A got chest physiotherapy with breathing exercises and ACBT whereas Group B got chest physiotherapy with breathing exercises. The treatment took 15-30 minutes and consisted of one session per day, treatment was given 6 days a week for up to 2 weeks and examined by using SPSS 22.
Detailed description
The experiment was randomized and controlled. To create groups A and B,48 individuals were selected by sample selection criteria. Evaluation of oxygen saturation and pulmonary function tests were taken using a pulse oximeter and spirometer. Group A got chest physiotherapy with breathing exercises and ACBT whereas Group B got chest physiotherapy with breathing exercises. The treatment took 15-30 minutes and consisted of one session per day, treatment was given 6 days a week for up to 2 weeks and examined by using SPSS 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study came to the conclusion that both techniques, breathing exercises with and without ACBT were beneficial in raising PaO2, FEV1, FVC, and the FEV1/FVC ratio as well as oxygen saturation. However, based on their mean differences, ACBT with breathing exercises was more beneficial in terms of the indicated end measures.
| Arm | Type | Receives |
|---|---|---|
| Chest physiotherapy with breathing exercises and ACBT | Experimental | Other: Chest physiotherapy with breathing exercises and ACBTGroup A will recieve chest physiotherapy with breathing exercises and ACBT. |
| Chest physiotherapy with breathing exercises | Experimental | Other: Chest physiotherapy with breathing exercisesGroup B will receive chest physiotherapy with breathing exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult population
Key exclusion criteria (4 listed)
- The patient cannot take part in the trial if they have any kind of muscular-skeletal issue.
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 |
|---|---|---|
| Chest physiotherapy with breathing exercises and ACBTAlso: ACTIVE CYCLE OF BREATHING TECHNIQUE (ACBT)Group A got chest physiotherapy with breathing exercises and ACBT | Other | Chest physiotherapy with breathing exercises and ACBT |
| Chest physiotherapy with breathing exercisesGroup B got chest physiotherapy with breathing exercises. | Other | Chest physiotherapy with breathing exercises |
Primary outcome
SPIROMETRY
Time frame: 4 weeks
Spirometry is a simple test used to help diagnose and monitor certain lung conditions by measuring how much air you can breathe out in one forced breath. In a spirometry test, while you are sitting, you breathe into a mouthpiece that is connected to an instrument called a spirometer. The spirometer records the amount and the rate of air that you breathe in and out over a period of time. When standing, some numbers might be slightly different.
PULSE OXIMETRY
Time frame: 4 weeks
pulse oximetry is a painless, noninvasive method of measuring the saturation of oxygen in a person's blood. Oxygen saturation is a crucial measure of how well the lungs are working. When we breathe in air, our lungs transmit oxygen into tiny blood vessels called capillaries. A normal pulse oximeter reading for your oxygen saturation level is between 95% and 100%. If you have a lung disease such as COPD or pneumonia, your normal oxygen saturation level may be lower.
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 13 Jun 2024.
- Background: PubMed 26496331Gastaldi AC, Paredi P, Talwar A, Meah S, Barnes PJ, Usmani OS. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.
- Background: PubMed 31790904van Mourik Y, Rutten FH, Bertens LCM, Cramer MJM, Lammers JJ, Gohar A, Reitsma JB, Moons KGM, Hoes AW. Clinical research study implementation of case-finding strategies for heart failure and chronic obstructive pulmonary disease in the elderly with reduced exercise tolerance or dyspnea: A cluster randomized trial. Am Heart J. 2020 Feb;220:73-81. doi: 10.1016/j.ahj.2019.08.021. Epub 2019 Sep 1.
- Background: PubMed 34045852Gephine S, Mucci P, Grosbois JM, Maltais F, Saey D. Physical Frailty in COPD Patients with Chronic Respiratory Failure. Int J Chron Obstruct Pulmon Dis. 2021 May 17;16:1381-1392. doi: 10.2147/COPD.S295885. eCollection 2021.
- 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.
Sidra Faisal, MS.CPPT principal investigator
Riphah International 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 Chest physiotherapy with breathing exercises and ACBT and Chest physiotherapy with breathing exercises in people with Post Covid-19 Patients, run by Riphah International University at 1 site in Pakistan.
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 4 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 13 Jun 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 Pakistan. 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?
SPIROMETRY (time frame: 4 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?
On the ClinicalTrials.gov record for NCT05491876, which also lists 3 linked publications.
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 13 Jun 2024.