Manual Diaphragm Release in Cleaning Laborer

Manual Diaphragmatic Release: Is It Helpful for Cleaning-laborers With Work-related Respiratory Hazards in Overcoming the Upsetting Respiratory Symptoms, Boosting Immune Response, and Enhancing Functional Ability?

This study intended to examine the effect of manual diaphragm release on pulmonary function, chest wall mobility, and functional ability in female occupational cleaners with respiratory hazards.

Study Overview

• Status: Completed
• Conditions: Respiratory System Abnormalities
• Intervention / Treatment: Other: Manual Diaphragm Release; Other: control group

Detailed Description

Cleaning chores have been linked to exposure to various chemical agents that have the potential to cause harmful effects on both the respiratory system and cardiovascular markers, many cleaning products and disinfectants contain ingredients that can act as airway irritants. One of the physical therapy procedures that is used to manage chest disorders is manual diaphragm release which aims to lengthen the diaphragm musculature whereas encouraging better and more proficient contraction.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al-Kharj, Riyadh, Saudi Arabia, 11432
      • Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female occupational cleaners.
• Age between 35 and 45.
• Had work-related respiratory hazards.
• Clinically stable.
• No exacerbation in the previous 6 weeks.
• Working in an occupation with respiratory hazards for at least 2 years.
• Mild to moderate air way obstruction.
• Willingness to participate in this study and provide a consent form.

Exclusion Criteria:

• Other cardiopulmonary diseases.
• Body mass index > 30 kg/ m2.
• Previous thoracic or abdominal surgery.
• Smokers and users of tobacco in any form (chewing, snuffing or water pipe).
• Systemic conditions (e.g., diabetes mellitus, hypertension).
• Sever airway obstructions.
• Inability to perform the required exercises.
• Inability to attend the scheduled sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Diaphragm Release; received 3sessions/ week for 12 consecutive weeks.	Other: Manual Diaphragm Release; The participant was supine, with his or her limbs relaxed. With the therapist's forearms aligned toward the participant's shoulders, the therapist gradually increased the depth of contact inside the costal margin during the subsequent respiratory cycles.; Other Names: inspiratory resistance
Experimental: control group; received 3sessions/ week for 12 consecutive weeks.	Other: control group; Respiratory re-training was given to participants in control group in form of slow and deep diaphragmatic breathing, exhalation through the nose with pursed lips (the participants were trained to emphasis on expiratory pressure against pursed lips), Breathing control and breathing-hold exercises, and Relaxation techniques: Other Names: Respiratory re-training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IgE	The Organon Teknika Microwell system (Organon Teknika Corp, Boxtel, the Netherlands) and an enzyme-linked immunosorbent test kits, were utilized to assess total serum IgE (IU/mL) at 450 nm.	at first week
Serum IgE	The Organon Teknika Microwell system (Organon Teknika Corp, Boxtel, the Netherlands) and an enzyme-linked immunosorbent test kits, were utilized to assess total serum IgE (IU/mL) at 450 nm.	after 12 weeks
Forced vital capacity	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	at first week
Forced vital capacity	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	after 12 weeks
Forced expiratory volume in one second	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	at first week
Forced expiratory volume in one second	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	after 12 weeks
pulmonary expiratory flow	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	at first week
pulmonary expiratory flow	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest wall mobility	measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).	at first week
Chest wall mobility	measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).	after 12 weeks
Functional performance	Assessed using the 6-minute walk test	at first week
Functional performance	Assessed using the 6-minute walk test	after 12 weeks

Collaborators and Investigators

• Sponsor: Maged Basha
• Collaborators: Cairo University; Prince Sattam Bin Abdulaziz University
• Investigators: Principal Investigator: Alshimaa Azab, PhD, Cairo University

Publications and helpful links

General Publications

• Malaguti C, Rondelli RR, de Souza LM, Domingues M, Dal Corso S. Reliability of chest wall mobility and its correlation with pulmonary function in patients with chronic obstructive pulmonary disease. Respir Care. 2009 Dec;54(12):1703-11.
• Zock JP, Kogevinas M, Sunyer J, Jarvis D, Toren K, Anto JM; European Community Respiratory Health Survey. Asthma characteristics in cleaning workers, workers in other risk jobs and office workers. Eur Respir J. 2002 Sep;20(3):679-85. doi: 10.1183/09031936.02.00279702.
• Mirabelli MC, London SJ, Charles LE, Pompeii LA, Wagenknecht LE. Occupation and three-year incidence of respiratory symptoms and lung function decline: the ARIC Study. Respir Res. 2012 Mar 20;13(1):24. doi: 10.1186/1465-9921-13-24.
• Bruurs ML, van der Giessen LJ, Moed H. The effectiveness of physiotherapy in patients with asthma: a systematic review of the literature. Respir Med. 2013 Apr;107(4):483-94. doi: 10.1016/j.rmed.2012.12.017. Epub 2013 Jan 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary function; functional ability; Respiratory hazards; chest wall mobility; Manual Diaphragmatic Release
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Congenital Abnormalities; Respiratory System Abnormalities
• Other Study ID Numbers: RHPT/022/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No