Manual Diaphragm Release in Cleaning Laborer

NCT05802355 | Completed

• 1 other identifier: RHPT/022/37
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory System Abnormalities

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Chest wall mobility

  at first week

• Chest wall mobility

  after 12 weeks

• Functional performance

  at first week

• Functional performance

  after 12 weeks

Study Arms (2)

Manual Diaphragm Release

EXPERIMENTAL

received 3sessions/ week for 12 consecutive weeks.

Other: Manual Diaphragm Release

control group

EXPERIMENTAL

received 3sessions/ week for 12 consecutive weeks.

Other: control group

Interventions

Manual Diaphragm Release OTHER

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.

Also known as: inspiratory resistance

Manual Diaphragm Release

control group OTHER

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:

Also known as: Respiratory re-training

control group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: female occupational cleaners working in an occupation with respiratory hazards for at least 2 years.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maged Basha: lead
• Cairo University: collaborator
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

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

Al Kharj, Riyadh Region, 11432, Saudi Arabia

Location

Related Publications (5)

• 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.

  PMID: 12358347 BACKGROUND

• 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.

  PMID: 22433119 BACKGROUND

• 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.

  PMID: 23333065 BACKGROUND

• 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.

  PMID: 19961637 RESULT

• Azab AR, Elnaggar RK, Hamouda DG, Aloraini GS, Alhegaili AS, Ahmed AS, Basha MA, Alsharidah AS, Kamel FH, Elshehawy AA. Respiratory and functional benefits of manual diaphragmatic release for cleaning-laborers exposed to occupational hazards. Physiother Res Int. 2024 Oct;29(4):e70001. doi: 10.1002/pri.70001.

  PMID: 39427332 DERIVED

MeSH Terms

Conditions

Respiratory System Abnormalities

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Alshimaa azab, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, College of Medical Rehabilitation, Qassim University

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 6, 2023
• Study Start: March 10, 2022
• Primary Completion: December 22, 2022
• Study Completion: February 3, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

SA (1)