Clinical trial NCT05802355: Manual Diaphragm Release in Cleaning Laborer
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory System Abnormalities
Keywords: Respiratory hazards
pulmonary function
chest wall mobility
functional ability
Manual Diaphragmatic Release
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Prince Sattam Bin Abdulaziz University
First posted: 2023-04-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum IgE
timeFrame: at first week
measure: Serum IgE
timeFrame: after 12 weeks
measure: Forced vital capacity
timeFrame: at first week
measure: Forced vital capacity
timeFrame: after 12 weeks
measure: Forced expiratory volume in one second
timeFrame: at first week
measure: Forced expiratory volume in one second
timeFrame: after 12 weeks
measure: pulmonary expiratory flow
timeFrame: at first week
measure: pulmonary expiratory flow
timeFrame: after 12 weeks
Secondary outcomes:
measure: Chest wall mobility
timeFrame: at first week
measure: Chest wall mobility
timeFrame: after 12 weeks
measure: Functional performance
timeFrame: at first week
measure: Functional performance
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Al-Kharj
country: Saudi Arabia
facility: Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
state: Riyadh
Study officials:
affiliation: Cairo University
name: Alshimaa azab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.