Respiratory System AbnormalitiesNCT05802355
Manual Diaphragm Release in Cleaning Laborer
A study testing Manual Diaphragm Release in people with Respiratory System Abnormalities, run by Maged Basha at 1 site in Saudi Arabia.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Respiratory System Abnormalities
- What is being tested?
- Manual Diaphragm Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Mar 2022to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11432
About this study
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?
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.
- Conditions
- Respiratory System Abnormalities
- Being tested
- Manual Diaphragm Release, control group
- Keywords
- Respiratory hazards, pulmonary function, chest wall mobility, functional ability, Manual Diaphragmatic Release
- Medical subject headings
- Respiratory System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Diaphragm ReleaseOther
Also called inspiratory resistance
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.
control groupOther
Also called Respiratory re-training
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:
| Study group | Role | What they receive |
|---|---|---|
| Manual Diaphragm Release | Experimental | received 3sessions/ week for 12 consecutive weeks. Receives: Other: Manual Diaphragm Release |
| control group | Experimental | received 3sessions/ week for 12 consecutive weeks. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 12 weeks
Forced vital capacity
measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards
Measured: at first week
Forced vital capacity
measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards
Measured: 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
Measured: 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
Measured: after 12 weeks
pulmonary expiratory flow
measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards
Measured: at first week
pulmonary expiratory flow
measured using a portable MicroLab spirometer (Vyaire Medical, Mettawa, Illinois) in accordance with current lung function testing standards
Measured: after 12 weeks
Secondary outcomes (4)
Chest wall mobility
measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).
Measured: at first week
Chest wall mobility
measured using tape measurement with maximum inspiration and expiration and the difference between them has been recorded in (cm).
Measured: after 12 weeks
Functional performance
Assessed using the 6-minute walk test
Measured: at first week
Functional performance
Assessed using the 6-minute walk test
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start10 Mar 2022
- Primary completion22 Dec 2022
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory System AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maged Basha
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Sponsor-investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa azab, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802355
- Sponsor's protocol ID
- RHPT/022/37
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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 12358347Mirabelli 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 22433119Bruurs 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 23333065Malaguti 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 19961637Azab 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.
PubMed 39427332
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05802355
- Acronym / sponsor ID
- RHPT/022/37
- Conditions
- Respiratory System Abnormalities
- Keywords
- Respiratory hazards, pulmonary function, chest wall mobility, functional ability, Manual Diaphragmatic Release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Maged BashaUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Diaphragm Release | Experimental | Other: Manual Diaphragm Releasereceived 3sessions/ week for 12 consecutive weeks. |
| control group | Experimental | Other: control groupreceived 3sessions/ week for 12 consecutive weeks. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female occupational cleaners.
- Age between 35 and 45.
- Had work-related respiratory hazards.
- Clinically stable.
- No exacerbation in the previous 6 weeks.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Diaphragm ReleaseAlso: inspiratory resistanceThe 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 | Manual Diaphragm Release |
| control groupAlso: Respiratory re-trainingRespiratory 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 | control group |
Primary outcome
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.
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.
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
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
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
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
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
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
4 secondary outcomes
Chest wall mobility
Time frame: at first week
Chest wall mobility
Time frame: after 12 weeks
Functional performance
Time frame: at first week
Functional performance
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 12358347Zock 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.
- Background: PubMed 22433119Mirabelli 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.
- Background: PubMed 23333065Bruurs 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 publication: PubMed 19961637Malaguti 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.
- Derived from this study: PubMed 39427332Azab 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.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshimaa azab, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Diaphragm Release in people with Respiratory System Abnormalities, run by Maged Basha at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgE (time frame: at first week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802355, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.