Back to resultsInfluence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19
Primary Purpose
COVID-19 Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
manual therapy
breathing exercise and prone position alone
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Breathing Exercise, COVID-19, manual diaphragmatic release, Pulmonary function parameters
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.
Sites / Locations
- Cairo Univeristy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
they received manual diaphragm release with conventional breathing exercises and prone positioning in addition to their prescribed medications.
they received conventional breathing exercises and prone positioning alone in addition to their prescribed medications.
Outcomes
Primary Outcome Measures
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.
FEV1
the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation
PEF
show the amount and rate of air that can be forcefully breathed out of the lungs.
FEV1/FVC
FEV1/FVC, also known as FEV1%) can help distinguish obstructive and restrictive lung diseases.
PEF25%
Peak expiratory flow at 25% of fvc and the most sensitive measure of airflow in peripheral airways where primary airflow obstruction originates.
PEF50%
Peak expiratory flow at 50% ofFVC
PEF 75%
Peak expiratory flow at 75% of FVC
PEF 25%/75%
Maximum flow rate in the middle 50% of forced expiration.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05903144
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
Breathing Exercise, COVID-19, manual diaphragmatic release, Pulmonary function parameters
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
they received manual diaphragm release with conventional breathing exercises and prone positioning in addition to their prescribed medications.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
they received conventional breathing exercises and prone positioning alone in addition to their prescribed medications.
Intervention Type
Other
Intervention Name(s)
manual therapy
Intervention Description
manual diaphragmatic release technique combined with breathing exercise
Intervention Type
Other
Intervention Name(s)
breathing exercise and prone position alone
Intervention Description
deep breathing exercise and prone position
Primary Outcome Measure Information:
Title
forced vital capacity FVC
Description
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.
Time Frame
pre study and 3 weeks post study for all participants
Title
FEV1
Description
the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation
Time Frame
pre study and 3 weeks post study for all participants
Title
PEF
Description
show the amount and rate of air that can be forcefully breathed out of the lungs.
Time Frame
pre study and 3 weeks post study for all participants
Title
FEV1/FVC
Description
FEV1/FVC, also known as FEV1%) can help distinguish obstructive and restrictive lung diseases.
Time Frame
pre study and 3 weeks post study for all participants
Title
PEF25%
Description
Peak expiratory flow at 25% of fvc and the most sensitive measure of airflow in peripheral airways where primary airflow obstruction originates.
Time Frame
pre study and 3 weeks post study for all participants
Title
PEF50%
Description
Peak expiratory flow at 50% ofFVC
Time Frame
pre study and 3 weeks post study for all participants
Title
PEF 75%
Description
Peak expiratory flow at 75% of FVC
Time Frame
pre study and 3 weeks post study for all participants
Title
PEF 25%/75%
Description
Maximum flow rate in the middle 50% of forced expiration.
Time Frame
pre study and 3 weeks post study for all participants
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mona M ghallab, doctoral
Organizational Affiliation
PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
neveen M nawar, master
Organizational Affiliation
master degree of physical therapy for cardiovascular disease and geriatrics, cairo univeristy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
karim I safaan, doctoral
Organizational Affiliation
PHD and lecturer of physical therapy for Surgery, cairo univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
kerolous I shehata, doctoral
Organizational Affiliation
PHD and lecturer Department of women health/ faculty of physical therapy /cairo university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amira I mostafa, doctoral
Organizational Affiliation
PHD and Assistant professor of chest disease Faculty of medicine cairo univeristy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mona A mohamed, doctoral
Organizational Affiliation
PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo Univeristy
City
Multiple Locations
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
26386894
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.
Results Reference
background
PubMed Identifier
37330786
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.
Results Reference
background
PubMed Identifier
31337743
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.
Results Reference
background
PubMed Identifier
27333481
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
36121338
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.
Results Reference
background
Learn more about this trial
Influence of Manual Diaphragm Release on Pulmonary Functions in Women With COVID-19
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