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COVID-19 PneumoniaNCT05903144

Influence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19

A study testing manual therapy and breathing exercise and prone position alone in people with COVID-19 Pneumonia, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Manual noninvasive respiratory techniques gained interest to treat respiratory pathologies related to COVID 19. This study designed to determine the combined effect of manual diaphragmatic release technique with the effect of conventional breathing exercises and prone positioning on pulmonary function parameters (FVC… Read more about this study

Who is it for?
Ages 35 to 45 years, women only
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
manual therapy and breathing exercise and prone position alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Jul 2022to 30 May 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 35 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • women with moderate COVID-19 illness diagnosed by a physician.
  • Patients with o2 saturation >94%Nonsmoker subjects.
  • age ranging from 35-45 years.
  • body mass index from 25 to 34 kg/m2.

Who cannot join

  • Unstable hemodynamic status.
  • Acute respiratory failure requiring intubation and impaired consciousness.
  • Inability to collaborate with prone positioning with refusal.
  • Change of mental status hindering response to instructions.
  • Poorly controlled hypertension (Mean systolic BP > 140 mmhg and \or diastolic BP > 40 mmhg).
  • Patients who take continuous o2 supplementation.
Show all 9Show fewer
  • Smoking.
  • Other chest diseases as (COPD-asthma-tuberculosis-cancer).
  • Male patients.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Cairo Univeristy

    Multiple Locations, Giza Governorate, 12613

Other trials in Egypt

About this study

Official title: Influence of Manual Diaphragm Release Combined With Conventional Breathing Exercises and Prone Positioning on Pulmonary Functions in Women With COVID-19

Manual noninvasive respiratory techniques gained interest to treat respiratory pathologies related to COVID 19. This study designed to determine the combined effect of manual diaphragmatic release technique with the effect of conventional breathing exercises and prone positioning on pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

Read the detailed description

Forty females were randomly assigned to two groups. Group A received manual diaphragm release with conventional breathing exercises and prone positioning. Group B received conventional breathing exercises and prone positioning. Both groups took their prescribed medications. Their ages ranged from 35 to 45 years and with moderate COVID-19 illness. Any cases with mild and severe COVID-19 illness, ICU admission, and chest diseases were excluded.

Main measures: pulmonary function parameters (FVC, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

Being tested
manual therapy, breathing exercise and prone position alone
Keywords
Breathing Exercise, COVID-19, manual diaphragmatic release, Pulmonary function parameters
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • manual therapyOther

    manual diaphragmatic release technique combined with breathing exercise

  • breathing exercise and prone position aloneOther

    deep breathing exercise and prone position

Study groups in NCT05903144
Study groupRoleWhat they receive
Study groupExperimentalthey received manual diaphragm release with conventional breathing exercises and prone positioning in addition to their prescribed medications.
Receives: Other: manual therapy; Other: breathing exercise and prone position alone
Control groupActive comparatorthey received conventional breathing exercises and prone positioning alone in addition to their prescribed medications.
Receives: Other: breathing exercise and prone position alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. forced vital capacity FVC

    the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible which is a common breathing test to check lung function.

    Measured: pre study and 3 weeks post study for all participants

  2. FEV1

    the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation

    Measured: pre study and 3 weeks post study for all participants

  3. PEF

    show the amount and rate of air that can be forcefully breathed out of the lungs.

    Measured: pre study and 3 weeks post study for all participants

  4. FEV1/FVC

    FEV1/FVC, also known as FEV1%) can help distinguish obstructive and restrictive lung diseases.

    Measured: pre study and 3 weeks post study for all participants

  5. PEF25%

    Peak expiratory flow at 25% of fvc and the most sensitive measure of airflow in peripheral airways where primary airflow obstruction originates.

    Measured: pre study and 3 weeks post study for all participants

  6. PEF50%

    Peak expiratory flow at 50% ofFVC

    Measured: pre study and 3 weeks post study for all participants

  7. PEF 75%

    Peak expiratory flow at 75% of FVC

    Measured: pre study and 3 weeks post study for all participants

  8. PEF 25%/75%

    Maximum flow rate in the middle 50% of forced expiration.

    Measured: pre study and 3 weeks post study for all participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start1 Jul 2022
  3. Primary completion30 Sep 2022
  4. Study completion30 May 2023

Resources

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
Forty females were randomly assigned to two groups. Group A received manual diaphragm release with conventional breathing exercises and prone positioning. Group B received conventional breathing exercises and prone positioning. Both groups took their prescribed medications. Their ages ranged from 35 to 45 years and with moderate COVID-19 illness. Any cases with mild and severe COVID-19 illness, ICU admission, and chest diseases were excluded.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903144
Sponsor's protocol ID
PFT in COVID-19
Status last verified
Jun 2023
First submitted
9 Jun 2023
Last updated
15 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.

    PubMed 26386894

  • Ahmad AM, Nawar NM, Dabess HM, Gallab MA. Effect of diaphragm manual release versus conventional breathing exercises and prone positioning on physical functional performance in women with COVID-19: A randomized trial. J Bodyw Mov Ther. 2023 Jul;35:311-319. doi: 10.1016/j.jbmt.2023.04.064. Epub 2023 Apr 21.

    PubMed 37330786

  • Elnaggar RK, Shendy MA, Mahmoud MZ. Prospective Effects of Manual Diaphragmatic Release and Thoracic Lymphatic Pumping in Childhood Asthma. Respir Care. 2019 Nov;64(11):1422-1432. doi: 10.4187/respcare.06716. Epub 2019 Jul 23.

    PubMed 31337743

  • Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.

    PubMed 27333481

  • Courtney R., Biland G., Ryan A., et al. Improvements in multi-dimensional measures of dysfunctional breathing in asthma patients after a combined manual therapy and breathing retraining protocol: a case series report. International Journal of Osteopathic Medicine 2019: (31) 36-43.

  • Nagy EN, Elimy DA, Ali AY, Ezzelregal HG, Elsayed MM. Influence of Manual Diaphragm Release Technique Combined with Inspiratory Muscle Training on Selected Persistent Symptoms in Men with Post-Covid-19 Syndrome: A Randomized Controlled Trial. J Rehabil Med. 2022 Oct 20;54:jrm00330. doi: 10.2340/jrm.v54.3972.

    PubMed 36121338

Questions about this trial

What is this clinical trial studying?

A study testing manual therapy and breathing exercise and prone position alone in people with COVID-19 Pneumonia, 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 4 inclusion and 9 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 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?

forced vital capacity FVC (time frame: pre study and 3 weeks post study for all participants). The study lists 8 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 NCT05903144, which also lists 6 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 15 Jun 2023.

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