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

NCT ID: NCT05903144

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-05-30

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).

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Study group

they received manual diaphragm release with conventional breathing exercises and prone positioning in addition to their prescribed medications.

Group Type: EXPERIMENTAL

manual therapy

Intervention Type: OTHER

manual diaphragmatic release technique combined with breathing exercise

breathing exercise and prone position alone

Intervention Type: OTHER

deep breathing exercise and prone position

Control group

they received conventional breathing exercises and prone positioning alone in addition to their prescribed medications.

Group Type: ACTIVE_COMPARATOR

breathing exercise and prone position alone

Intervention Type: OTHER

deep breathing exercise and prone position

Interventions

manual therapy

manual diaphragmatic release technique combined with breathing exercise

Intervention Type: OTHER

breathing exercise and prone position alone

deep breathing exercise and prone position

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

mona abd el raouf ghallab

lecturer at faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mona M ghallab, doctoral

Role: PRINCIPAL_INVESTIGATOR

PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy

neveen M nawar, master

Role: STUDY_CHAIR

master degree of physical therapy for cardiovascular disease and geriatrics, cairo univeristy

karim I safaan, doctoral

Role: STUDY_DIRECTOR

PHD and lecturer of physical therapy for Surgery, cairo univeristy

kerolous I shehata, doctoral

Role: STUDY_DIRECTOR

PHD and lecturer Department of women health/ faculty of physical therapy /cairo university

Amira I mostafa, doctoral

Role: STUDY_DIRECTOR

PHD and Assistant professor of chest disease Faculty of medicine cairo univeristy

mona A mohamed, doctoral

Role: STUDY_CHAIR

PHD and lecturer of physical therapy for cardiovascular disease and geriatrics,cairo univeristy

Locations

Cairo Univeristy

Multiple Locations, Giza Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 26386894 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37330786 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31337743 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27333481 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 36121338 (View on PubMed)

Other Identifiers

PFT in COVID-19

Identifier Type: -

Identifier Source: org_study_id