CClinicalTrials.gg
CompletedNCT05802355Updated Apr 6, 2023

Manual Diaphragm Release in Cleaning Laborer

An interventional study of Manual Diaphragm Release and control group in Respiratory System Abnormalities, sponsored by Maged Basha. Completed at 1 site in Saudi Arabia. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Maged Basha · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory System Abnormalities

Keywords

  • Respiratory hazards
  • pulmonary function
  • chest wall mobility
  • functional ability
  • Manual Diaphragmatic Release
03

In context

Lead sponsor

Maged Basha is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Manual Diaphragm Release

    received 3sessions/ week for 12 consecutive weeks.

    Other: Manual Diaphragm Release

  • Experimental
    control group

    received 3sessions/ week for 12 consecutive weeks.

    Other: control group

Interventions

  • OtherManual 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.

    Also known as: inspiratory resistance

  • Othercontrol 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:

    Also known as: Respiratory re-training

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at first week

  2. 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.

    Time frame: after 12 weeks

  3. Forced vital capacity

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

    Time frame: at first week

  4. Forced vital capacity

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

    Time frame: after 12 weeks

  5. Forced expiratory volume in one second

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

    Time frame: at first week

  6. Forced expiratory volume in one second

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

    Time frame: after 12 weeks

  7. pulmonary expiratory flow

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

    Time frame: at first week

  8. pulmonary expiratory flow

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

    Time frame: after 12 weeks

Secondary outcomes

  1. Chest wall mobility

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

    Time frame: at first week

  2. Chest wall mobility

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

    Time frame: after 12 weeks

  3. Functional performance

    Assessed using the 6-minute walk test

    Time frame: at first week

  4. Functional performance

    Assessed using the 6-minute walk test

    Time frame: after 12 weeks

07

Study locations

1 site
  • Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
    Al-Kharj, Riyadh 11432, Saudi Arabia
08

References and documents

Publications

  • 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. PubMed 12358347 ↗
  • 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. PubMed 22433119 ↗
  • 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. PubMed 23333065 ↗
  • 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. PubMed 19961637 ↗

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05802355
Lead sponsor
Maged Basha
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
Responsible party
Maged Basha (Assistant Professor, College of Medical Rehabilitation, Qassim University, Qassim University) — Sponsor-investigator
First posted
Apr 6, 2023
Start date
Mar 10, 2022
Primary completion
Dec 22, 2022
Completion
Feb 3, 2023
Last update
Apr 6, 2023

Study contacts

Alshimaa azab, PhD
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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