Covid19NCT04710771
Effect of Prone Positioning in Patients With COVID-19
A study testing Prone Lying Position and alternate nostril breathing in people with Covid19, run by Sialkott College of Physical Therapy at 1 site in Pakistan.
Trial summary
COVID-19 is affecting the people around the world and the infected individuals' may either stay asymptomatic or present to hospitals with severe distress and life threatening symptoms. The objective of the study is to investigate role of Prone positioning and alternate nostril breathing in patients with Covid-19. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Prone Lying Position and alternate nostril breathing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Nov 2020to 29 Jan 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40-80 Gender: Both GCS score:15
Who cannot join
- COPD Intubated ARDS Smoker Neurological Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prone Positioning and Alternate Nostril Breathing Technique in Patients With COVID-19: A Quasi Experimental Study.
COVID-19 is affecting the people around the world and the infected individuals' may either stay asymptomatic or present to hospitals with severe distress and life threatening symptoms. The objective of the study is to investigate role of Prone positioning and alternate nostril breathing in patients with Covid-19.
Read the detailed description
In this quasi experimental study, 30 patients aged 40-80 years of either gender with a confirmed diagnosis of COVID-19 receiving supplemental oxygen were recruited from DHQ Hospital Faisalabad. patients were grouped into two A \& B. We collected baseline data on demographics and anthropometrics. After baseline data collection, all the patients were helped into the prone position, which was maintained for a minimum duration of three hours. After that patients in group B performed alternate nostril breathing for 10 minutes with help of physiotherapist. Clinical data were re-collected on 3rd day of intervention one hour after returning to the supine position in group A and after alternate nostril breathing in group B. The main study outcome was the variation in oxygenation (partial pressure of oxygen [PaO2]/ fractional concentration of oxygen in inspired air [FiO2]) between baseline and resupination, and General psychological state through GAD-7 General anxiety disorder questionnaire.
- Conditions
- Covid19
- Being tested
- Prone Lying Position, alternate nostril breathing
- Keywords
- Covid-19, General Anxiety Disorder-7, Prone Position, Alternate Nostril Breathing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone Lying PositionOther
Also called Positioning
patient lies on his/ her stomach facing floor.
alternate nostril breathingOther
Also called breathing technique
patient inspires with one nostril at a time, right or left one by one and expires by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | Patient performed prone lying position for three hours. Receives: Other: Prone Lying Position |
| Group-B | Active comparator | along with Prone lying position, patients also performed alternate nostril breathing for ten minutes. Receives: Other: Prone Lying Position; Other: alternate nostril breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2
partial pressure of oxygen.
Measured: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.
FiO2
Fractional concentration of oxygen in inspired air [FiO2])
Measured: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.
General Anxiety Disorder-7 Score
general anxiety disorder-7 score ranges from 0-21, out of which 0-4 means minimal anxiety, 5-9 stands for mild anxiety, 10-14 for moderate and 15-21 for severe anxiety.
Measured: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start23 Nov 2020
- Primary completion15 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sialkott College of Physical Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahreen Anwar, PhD, Principal investigator, Independent Medical College, Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710771
- Sponsor's protocol ID
- 138-2020
- Status last verified
- May 2025
- First submitted
- 9 Jan 2021
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Positioning and Alternate Nostril Breathing Technique in Patients With COVID-19: A Quasi Experimental Study.
- ClinicalTrials.gov ID
- NCT04710771
- Acronym / sponsor ID
- 138-2020
- Conditions
- Covid19
- Keywords
- Covid-19, General Anxiety Disorder-7, Prone Position, Alternate Nostril Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sialkott College of Physical TherapyUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 15 Jan 2021 (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.
COVID-19 is affecting the people around the world and the infected individuals' may either stay asymptomatic or present to hospitals with severe distress and life threatening symptoms. The objective of the study is to investigate role of Prone positioning and alternate nostril breathing in patients with Covid-19.
Detailed description
In this quasi experimental study, 30 patients aged 40-80 years of either gender with a confirmed diagnosis of COVID-19 receiving supplemental oxygen were recruited from DHQ Hospital Faisalabad. patients were grouped into two A \& B. We collected baseline data on demographics and anthropometrics. After baseline data collection, all the patients were helped into the prone position, which was maintained for a minimum duration of three hours. After that patients in group B performed alternate nostril breathing for 10 minutes with help of physiotherapist. Clinical data were re-collected on 3rd day of intervention one hour after returning to the supine position in group A and after alternate nostril breathing in group B. The main study outcome was the variation in oxygenation (partial pressure of oxygen [PaO2]/ fractional concentration of oxygen in inspired air [FiO2]) between baseline and resupination, and General psychological state through GAD-7 General anxiety disorder questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Other: Prone Lying PositionPatient performed prone lying position for three hours. |
| Group-B | Active comparator | Other: Prone Lying Position, Other: alternate nostril breathingalong with Prone lying position, patients also performed alternate nostril breathing for ten minutes. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 40-80 Gender: Both GCS score:15
Key exclusion criteria (1 listed)
- COPD Intubated ARDS Smoker Neurological Disorder
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 |
|---|---|---|
| Prone Lying PositionAlso: Positioningpatient lies on his/ her stomach facing floor. | Other | Group-A, Group-B |
| alternate nostril breathingAlso: breathing techniquepatient inspires with one nostril at a time, right or left one by one and expires by mouth. | Other | Group-B |
Primary outcome
PaO2
Time frame: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.
partial pressure of oxygen.
FiO2
Time frame: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.
Fractional concentration of oxygen in inspired air [FiO2])
General Anxiety Disorder-7 Score
Time frame: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.
general anxiety disorder-7 score ranges from 0-21, out of which 0-4 means minimal anxiety, 5-9 stands for mild anxiety, 10-14 for moderate and 15-21 for severe anxiety.
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 15 May 2025.
- 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.
Sahreen Anwar, PhD principal investigator
Independent Medical College, Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone Lying Position and alternate nostril breathing in people with Covid19, run by Sialkott College of Physical Therapy 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 1 inclusion and 1 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 15 May 2025. 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?
PaO2 (time frame: Change in score before the intervention on 1st day of intervention and on 3rd day one hour after the intervention.). The study lists 3 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 15 May 2025.