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Manual Diaphragm Release in Cleaning Laborer

Primary Purpose

Respiratory System Abnormalities

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Manual Diaphragm Release

control group

About this trial

This is an interventional treatment trial for Respiratory System Abnormalities focused on measuring Respiratory hazards, pulmonary function, chest wall mobility, functional ability, Manual Diaphragmatic Release

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Manual Diaphragm Release

control group

Arm Description

received 3sessions/ week for 12 consecutive weeks.

Outcomes

Primary Outcome Measures

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.

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.

Forced vital capacity

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Forced vital capacity

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Forced expiratory volume in one second

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Forced expiratory volume in one second

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

pulmonary expiratory flow

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

pulmonary expiratory flow

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Secondary Outcome Measures

Chest wall mobility

measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).

Chest wall mobility

measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).

Functional performance

Assessed using the 6-minute walk test

Functional performance

Assessed using the 6-minute walk test

Full Information

NCT ID

NCT05802355

First Posted

March 27, 2023

Last Updated

March 27, 2023

Sponsor

Maged Basha

Collaborators

Cairo University, Prince Sattam Bin Abdulaziz University

1. Study Identification

Unique Protocol Identification Number

NCT05802355

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

March 10, 2022 (Actual)

Primary Completion Date

December 22, 2022 (Actual)

Study Completion Date

February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Maged Basha

Collaborators

Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory System Abnormalities

Keywords

Respiratory hazards, pulmonary function, chest wall mobility, functional ability, Manual Diaphragmatic Release

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual Diaphragm Release

Arm Type

Experimental

Arm Description

received 3sessions/ week for 12 consecutive weeks.

Arm Title

control group

Arm Type

Experimental

Arm Description

received 3sessions/ week for 12 consecutive weeks.

Intervention Type

Other

Intervention Name(s)

Manual Diaphragm Release

Other Intervention Name(s)

inspiratory resistance

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

control group

Other Intervention Name(s)

Respiratory re-training

Intervention Description

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:

Primary Outcome Measure Information:

Title

Serum IgE

Description

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.

Time Frame

at first week

Title

Serum IgE

Description

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.

Time Frame

after 12 weeks

Title

Forced vital capacity

Description

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Time Frame

at first week

Title

Forced vital capacity

Description

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Time Frame

after 12 weeks

Title

Forced expiratory volume in one second

Description

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Time Frame

at first week

Title

Forced expiratory volume in one second

Description

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Time Frame

after 12 weeks

Title

pulmonary expiratory flow

Description

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Time Frame

at first week

Title

pulmonary expiratory flow

Description

measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards

Time Frame

after 12 weeks

Secondary Outcome Measure Information:

Title

Chest wall mobility

Description

measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).

Time Frame

at first week

Title

Chest wall mobility

Description

measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).

Time Frame

after 12 weeks

Title

Functional performance

Description

Assessed using the 6-minute walk test

Time Frame

at first week

Title

Functional performance

Description

Assessed using the 6-minute walk test

Time Frame

after 12 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female occupational cleaners working in an occupation with respiratory hazards for at least 2 years.

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alshimaa azab, PhD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

City

Al-Kharj

State/Province

Riyadh

ZIP/Postal Code

11432

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

12358347

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.

Results Reference

background

PubMed Identifier

22433119

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.

Results Reference

background

PubMed Identifier

23333065

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.

Results Reference

background

PubMed Identifier

19961637

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.

Results Reference

result

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Manual Diaphragm Release in Cleaning Laborer

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