Manual Diaphragm Release in Cleaning Laborer

Respiratory System Abnormalities Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802355
• Other study ID #: RHPT/022/37
• Status: Completed
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: March 2023
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 3, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory System Abnormalities

Intervention

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.
• 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:

Locations

Country	Name	City	State
Saudi Arabia	Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University	Al-Kharj	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Maged Basha	Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Forced vital capacity	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	at first week
Primary	Forced vital capacity	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	after 12 weeks
Primary	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
Primary	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
Primary	pulmonary expiratory flow	measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards	at first week
Primary	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	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
Secondary	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
Secondary	Functional performance	Assessed using the 6-minute walk test	at first week
Secondary	Functional performance	Assessed using the 6-minute walk test	after 12 weeks