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Completed

NCT Number: NCT05802355

Manual Diaphragm Release in Cleaning Laborer

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.

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Key information

Conditions

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

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Al Kharj, Riyadh Region, 11432, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: inspiratory resistance

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:

Other names: Respiratory re-training

Primary outcomes

  1. Serum IgE

    Time frame: at first week

    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.

  2. Serum IgE

    Time frame: after 12 weeks

    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.

  3. Forced vital capacity

    Time frame: at first week

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

  4. Forced vital capacity

    Time frame: after 12 weeks

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

  5. Forced expiratory volume in one second

    Time frame: at first week

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

  6. Forced expiratory volume in one second

    Time frame: after 12 weeks

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

  7. pulmonary expiratory flow

    Time frame: at first week

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

  8. pulmonary expiratory flow

    Time frame: after 12 weeks

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

Secondary outcomes

  1. Chest wall mobility

    Time frame: at first week

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

  2. Chest wall mobility

    Time frame: after 12 weeks

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

  3. Functional performance

    Time frame: at first week

    Assessed using the 6-minute walk test

  4. Functional performance

    Time frame: after 12 weeks

    Assessed using the 6-minute walk test

Sponsors and collaborators

Lead sponsor

Maged Basha

Other

Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study 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?

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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