Corona Virus InfectionCOVID19NCT05517941
Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
A study testing active cycle breathing and incentive spirometer in people with Corona Virus Infection, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- active cycle breathing and incentive spirometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 1 Jun 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages from 45-75 years old
- COVID-19 patients with SpO2 > 85
- oxygen face Mask or a reservoir mask
Who cannot join
- Mechanically ventilated,
- Cancer,
- Chronic respiratory disease (defined as asthma or chronic obstructive pulmonary disease),
- End-stage renal disease,
- Liver disease (defined as compensated/decompensated liver cirrhosis),
- Chronic neurological disease (defined as previous neurological disease),
- Chronic cardiovascular disease,
- Active smoker
Trial locations and contacts
1 site in 1 country.
About this study
this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient
Read the detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus that emerged in 2019 and causes coronavirus disease 2019 (COVID-19).Individuals with COVID-19 can present with an influenza-like illness and respiratory tract infection demonstrating fever (89%),cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%). The spectrum of disease severity ranges from asymptomatic infection or mild upper respiratory tract illness through to severe viral pneumonia with respiratory failure and/or death. Current reports estimate that 80% of cases are asymptomatic or mild; 15% of cases are severe (infection requiring oxygen); and 5% are critical, requiring ventilation and life support. Based on emerging data, individuals at the highest risk of developing severe COVID-19 disease requiring hospitalization and/or ICU support are those who are older, male, have at least one co-existing comorbidity, elevated D-dimer levels, and/or lymphocytopenia. Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable to individual patients. It assists bronchial clearance by enhancing mucociliary clearance whilst reducing adverse effects such as hypoxemia or increased airflow obstruction. Incentive spirometry (IS) is a type of deep breathing exercise that is widely used for lung expansion and the prevention of pulmonary complications in children, adults, and the elderly. IS is used to encourage the patient to inhale to lung capacity through maximal inspiration aided with visual feedback. These maneuvers increase transpulmonary pressure and therefore increase chest-wall volume.one hundred patients will be allocated randomly to two groups; one group will receive active cycle breathing with an incentive spirometer and the other will receive active cycle breathing
- Conditions
- Corona Virus Infection
- Being tested
- active cycle breathing, incentive spirometer
- Keywords
- active cycle breathing, incentive spirometer, covid19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active cycle breathingOther
The active cycle breathing technique will involve three steps: breathing control, thoracic expansion exercise, and forced expiration technique, In breathing control, the patient will sit comfortably in a chair and breathe at a normal rate and depth using the lower chest. In the thoracic expansion exercise, the physical therapist rested his/her hands on the patient's epigastrium and guided the patient's breathing so that they breathed at a slow and deep rate using the lower chest, then held their breath for 2 s and fully exhaled; this was repeated two or three times, then the patient returned to breathing control. For the forced expiration technique, the physical therapist asked the patient to inhale deeply while simultaneously contracting the abdominal muscle and keeping the mouth and throat open. They then held their breath for 2 s, followed by vigorous exhalation
incentive spirometerOther
Incentive spirometry is accomplished by using a device that provides feedback when the patient inhales at a predetermined flow and sustains the inflation for at least 5 seconds. The patient is instructed to hold the spirometer in an upright position, exhale normally, and then place the lips tightly around the mouthpiece. The next step is a slow inhalation to raise the ball (flow-oriented) or the piston/ plate (volume-oriented) in the chamber to the set target. At maximum inhalation, the mouthpiece is removed, followed by a breath-hold and normal exhalation.
| Study group | Role | What they receive |
|---|---|---|
| active cycle breathing exercise | Experimental | patients will receive Active cycle of breathing techniques daily for 2 weeks Receives: Other: active cycle breathing |
| incentive spirometer | Experimental | patients will receive incentive spirometer and active cycle breathing daily for 2 weeks Receives: Other: active cycle breathing; Other: incentive spirometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood gas
arterial blood gas analysis will be measured using arterial blood sample
Measured: up to two weeks
Secondary outcomes (2)
C-reactive protein
C-reactive protein will be measured by blood sample analysis
Measured: up to two weeks
Oxygen saturation
SpO2 will be measure by pulse oximeter
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start15 Sep 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 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 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
- Model description
- active cycle breathing and incentive spirometer
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517941
- Sponsor's protocol ID
- p.t.REC/012/003416
- Acronym
- COVID19
- Status last verified
- Jun 2023
- First submitted
- 24 Aug 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient
- ClinicalTrials.gov ID
- NCT05517941
- Acronym / sponsor ID
- COVID19 / p.t.REC/012/003416
- Conditions
- Corona Virus Infection
- Keywords
- active cycle breathing, incentive spirometer, covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 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.
this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient
Detailed description
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus that emerged in 2019 and causes coronavirus disease 2019 (COVID-19).Individuals with COVID-19 can present with an influenza-like illness and respiratory tract infection demonstrating fever (89%),cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%). The spectrum of disease severity ranges from asymptomatic infection or mild upper respiratory tract illness through to severe viral pneumonia with respiratory failure and/or death. Current reports estimate that 80% of cases are asymptomatic or mild; 15% of cases are severe (infection requiring oxygen); and 5% are critical, requiring ventilation and life support. Based on emerging data, individuals at the highest risk of developing severe COVID-19 disease requiring hospitalization and/or ICU support are those who are older, male, have at least one co-existing comorbidity, elevated D-dimer levels, and/or lymphocytopenia. Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable to individual patients. It assists bronchial clearance by enhancing mucociliary clearance whilst reducing adverse effects such as hypoxemia or increased airflow obstruction. Incentive spirometry (IS) is a type of deep breathing exercise that is widely used for lung expansion and the prevention of pulmonary complications in children, adults, and the elderly. IS is used to encourage the patient to inhale to lung capacity through maximal inspiration aided with visual feedback. These maneuvers increase transpulmonary pressure and therefore increase chest-wall volume.one hundred patients will be allocated randomly to two groups; one group will receive active cycle breathing with an incentive spirometer and the other will receive active cycle breathing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- active cycle breathing and incentive spirometer
| Arm | Type | Receives |
|---|---|---|
| active cycle breathing exercise | Experimental | Other: active cycle breathingpatients will receive Active cycle of breathing techniques daily for 2 weeks |
| incentive spirometer | Experimental | Other: active cycle breathing, Other: incentive spirometerpatients will receive incentive spirometer and active cycle breathing daily for 2 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages from 45-75 years old
- COVID-19 patients with SpO2 > 85
- oxygen face Mask or a reservoir mask
Key exclusion criteria (8 listed)
- Mechanically ventilated,
- Cancer,
- Chronic respiratory disease (defined as asthma or chronic obstructive pulmonary disease),
- End-stage renal disease,
- Liver disease (defined as compensated/decompensated liver cirrhosis),
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 |
|---|---|---|
| active cycle breathingThe active cycle breathing technique will involve three steps: breathing control, thoracic expansion exercise, and forced expiration technique, In breathing control, the patient will sit comfortably in a chair and breathe at a normal rate and depth using the lower chest. In the thoracic expansion exercise, the physical therapist rested his/her hands on the patient's epigastrium and guided the patient's breathing so that they breathed at a slow and deep rate using the lower chest, then held their breath for 2 s and fully exhaled; this was repeated two or three times, then the patient returned to breathing control. For the forced expiration technique, the physical therapist asked the patient to inhale deeply while simultaneously contracting the abdominal muscle and keeping the mouth and throat open. They then held their breath for 2 s, followed by vigorous exhalation | Other | active cycle breathing exercise, incentive spirometer |
| incentive spirometerIncentive spirometry is accomplished by using a device that provides feedback when the patient inhales at a predetermined flow and sustains the inflation for at least 5 seconds. The patient is instructed to hold the spirometer in an upright position, exhale normally, and then place the lips tightly around the mouthpiece. The next step is a slow inhalation to raise the ball (flow-oriented) or the piston/ plate (volume-oriented) in the chamber to the set target. At maximum inhalation, the mouthpiece is removed, followed by a breath-hold and normal exhalation. | Other | incentive spirometer |
Primary outcome
arterial blood gas
Time frame: up to two weeks
arterial blood gas analysis will be measured using arterial blood sample
2 secondary outcomes
C-reactive protein
Time frame: up to two weeks
Oxygen saturation
Time frame: up to two weeks
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 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active cycle breathing and incentive spirometer in people with Corona Virus Infection, 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 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 13 Jun 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?
arterial blood gas (time frame: up to two weeks). 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 13 Jun 2023.