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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05903144
• Other study ID #: PFT in COVID-19
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, FEV1, PEF, FEV1/FVC, FEF25, FEF50, FEF75, FEF25/75).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Smoking.

• Other chest diseases as (COPD-asthma-tuberculosis-cancer).

• Male patients.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia

Intervention

Other:
• manual therapy
manual diaphragmatic release technique combined with breathing exercise
• breathing exercise and prone position alone
deep breathing exercise and prone position

Locations

Country	Name	City	State
Egypt	Cairo Univeristy	Multiple Locations	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Ahmad AM, Nawar NM, Dabess HM, et al. 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 (35):311-319.

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre study and 3 weeks post study for all participants
Primary	FEV1	the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation	pre study and 3 weeks post study for all participants
Primary	PEF	show the amount and rate of air that can be forcefully breathed out of the lungs.	pre study and 3 weeks post study for all participants
Primary	FEV1/FVC	FEV1/FVC, also known as FEV1%) can help distinguish obstructive and restrictive lung diseases.	pre study and 3 weeks post study for all participants
Primary	PEF25%	Peak expiratory flow at 25% of fvc and the most sensitive measure of airflow in peripheral airways where primary airflow obstruction originates.	pre study and 3 weeks post study for all participants
Primary	PEF50%	Peak expiratory flow at 50% ofFVC	pre study and 3 weeks post study for all participants
Primary	PEF 75%	Peak expiratory flow at 75% of FVC	pre study and 3 weeks post study for all participants
Primary	PEF 25%/75%	Maximum flow rate in the middle 50% of forced expiration.	pre study and 3 weeks post study for all participants