Clinical trial NCT05903144: Influence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19
Official title: Influence of Manual Diaphragm Release Combined With Conventional Breathing Exercises and Prone Positioning on Pulmonary Functions in Women With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Keywords: Breathing Exercise
COVID-19
manual diaphragmatic release
Pulmonary function parameters
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: forced vital capacity FVC
timeFrame: pre study and 3 weeks post study for all participants
measure: FEV1
timeFrame: pre study and 3 weeks post study for all participants
measure: PEF
timeFrame: pre study and 3 weeks post study for all participants
measure: FEV1/FVC
timeFrame: pre study and 3 weeks post study for all participants
measure: PEF25%
timeFrame: pre study and 3 weeks post study for all participants
measure: PEF50%
timeFrame: pre study and 3 weeks post study for all participants
measure: PEF 75%
timeFrame: pre study and 3 weeks post study for all participants
measure: PEF 25%/75%
timeFrame: pre study and 3 weeks post study for all participants
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Egypt
facility: Cairo Univeristy
state: Giza
Study officials:
affiliation: PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy
name: mona M ghallab, doctoral
role: PRINCIPAL_INVESTIGATOR
affiliation: master degree of physical therapy for cardiovascular disease and geriatrics, cairo univeristy
name: neveen M nawar, master
role: STUDY_CHAIR
affiliation: PHD and lecturer of physical therapy for Surgery, cairo univeristy
name: karim I safaan, doctoral
role: STUDY_DIRECTOR
affiliation: PHD and lecturer Department of women health/ faculty of physical therapy /cairo university
name: kerolous I shehata, doctoral
role: STUDY_DIRECTOR
affiliation: PHD and Assistant professor of chest disease Faculty of medicine cairo univeristy
name: Amira I mostafa, doctoral
role: STUDY_DIRECTOR
affiliation: PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy
name: mona A mohamed, doctoral
role: STUDY_CHAIR
References:
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.
citation: 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.
citation: 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.
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.
citation: 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.
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.