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

NCT05903144 | Completed

• 1 other identifier: PFT in COVID-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19 Pneumonia

Keywords

Breathing Exercise; COVID-19; manual diaphragmatic release; Pulmonary function parameters

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• PEF50%

  Peak expiratory flow at 50% ofFVC

  pre study and 3 weeks post study for all participants

• PEF 75%

  Peak expiratory flow at 75% of FVC

  pre study and 3 weeks post study for all participants

• PEF 25%/75%

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

  pre study and 3 weeks post study for all participants

Study Arms (2)

Study group

EXPERIMENTAL

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

Other: manual therapy; Other: breathing exercise and prone position alone

Control group

ACTIVE COMPARATOR

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

Other: breathing exercise and prone position alone

Interventions

manual therapy OTHER

manual diaphragmatic release technique combined with breathing exercise

Study group

breathing exercise and prone position alone OTHER

deep breathing exercise and prone position

Control group; Study group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Univeristy

Multiple Locations, Giza Governorate, 12613, Egypt

Location

Related Publications (6)

• 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.

  PMID: 26386894 BACKGROUND

• 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.

  PMID: 37330786 BACKGROUND

• 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.

  PMID: 31337743 BACKGROUND

• 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.

  PMID: 27333481 BACKGROUND

• 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.

  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.

  PMID: 36121338 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Musculoskeletal Manipulations; Breathing Exercises; Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Mind-Body Therapies; Exercise Movement Techniques; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• mona M ghallab, doctoral

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

  PRINCIPAL INVESTIGATOR

• neveen M nawar, master

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

  STUDY CHAIR

• 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 DIRECTOR

• mona A mohamed, doctoral

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of physical therapy

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: May 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

EG (1)