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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05903144
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.9
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia	Other: manual therapy; Other: breathing exercise and prone position alone	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Influence of Manual Diaphragm Release Combined With Conventional Breathing Exercises and Prone Positioning on Pulmonary Functions in Women With COVID-19
• Actual Study Start Date: Jul 1, 2022
• Actual Primary Completion Date: Sep 30, 2022
• Actual Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group they received manual diaphragm release with conventional breathing exercises and prone positioning in addition to their prescribed medications.	Other: manual therapy; manual diaphragmatic release technique combined with breathing exercise; Other: breathing exercise and prone position alone; deep breathing exercise and prone position
Active Comparator: Control group they received conventional breathing exercises and prone positioning alone in addition to their prescribed medications.	Other: breathing exercise and prone position alone; deep breathing exercise and prone position

Outcome Measures

Primary Outcome Measures

1. forced vital capacity FVC [pre study and 3 weeks post study for all participants]

   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.

2. FEV1 [pre study and 3 weeks post study for all participants]

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

3. PEF [pre study and 3 weeks post study for all participants]

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

4. FEV1/FVC [pre study and 3 weeks post study for all participants]

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

5. PEF25% [pre study and 3 weeks post study for all participants]

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

6. PEF50% [pre study and 3 weeks post study for all participants]

   Peak expiratory flow at 50% ofFVC

7. PEF 75% [pre study and 3 weeks post study for all participants]

   Peak expiratory flow at 75% of FVC

8. PEF 25%/75% [pre study and 3 weeks post study for all participants]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo Univeristy	Multiple Locations	Giza	Egypt	12613

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: mona M ghallab, doctoral, PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy
• Study Chair: neveen M nawar, master, master degree of physical therapy for cardiovascular disease and geriatrics, cairo univeristy
• Study Director: karim I safaan, doctoral, PHD and lecturer of physical therapy for Surgery, cairo univeristy
• Study Director: kerolous I shehata, doctoral, PHD and lecturer Department of women health/ faculty of physical therapy /cairo university
• Study Director: Amira I mostafa, doctoral, PHD and Assistant professor of chest disease Faculty of medicine cairo univeristy
• Study Chair: mona A mohamed, doctoral, PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: mona abd el raouf ghallab, lecturer at faculty of physical therapy, Cairo University
• ClinicalTrials.gov Identifier: NCT05903144
• Other Study ID Numbers: PFT in COVID-19
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by mona abd el raouf ghallab, lecturer at faculty of physical therapy, Cairo University: Breathing Exercise; COVID-19; manual diaphragmatic release; Pulmonary function parameters
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jun 15, 2023