AsthmaNCT06460857
Effects of MDRT vs CEE on Pulmonary Functions, Chest Expansion and Asthma Control in Asthma Patients
A study testing Manual Diaphragmatic Release Technique and Chest Wall Expansion Exercises in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of manual diaphragmatic release technique (MDRT) versus chest wall expansion exercises on pulmonary function, chest wall expansion and asthma control in patients with asthma. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Manual Diaphragmatic Release Technique and Chest Wall Expansion Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 1 Aug 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Medically diagnosed asthma patients.
- Aged 35-60 years.
- Patient should be non-smoker or ex-smoker for last 6 months
Who cannot join
- • Patients having other cardiac or respiratory diseases.
- Patient having thoracic or abdominal surgeries.
- Pregnancy and uncontrolled hemodynamic parameters.
- Inability of Patient to understand instruction due to mental disorder.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Zohra Shafi Free Trust Hospital
Lahore, Punjab Province, 05466
Qurat ul-Ain, MSCPPT, +92-031-21707719
Khadija Ghafoor, MSCPPT
About this study
Official title: Effects of Manual Diaphragmatic Release Technique Versus Chest Wall Expansion Exercises on Pulmonary Function, Chest Wall Expansion and Asthma Control in Patients With Asthma
To determine the effects of manual diaphragmatic release technique (MDRT) versus chest wall expansion exercises on pulmonary function, chest wall expansion and asthma control in patients with asthma.
Read the detailed description
Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as A for Group A and B for group B. At the beginning of the study, a formal educational session, lasting about 30 minutes will be given by the physiotherapist dealing with the treatment/interventions.
Group A: It will receive MDRT and generalized body stretching. Group B: It will receive Chest Expansion Exercises and generalized body stretching.
Frequency of patient's visit will be tailored with minimum of 2-3 visits per week for 4 weeks.
- Conditions
- Asthma
- Being tested
- Manual Diaphragmatic Release Technique, Chest Wall Expansion Exercises
- Keywords
- Manual Diaphragmatic Release Technique, Chest Wall Expansion Exercises, Pulmonary Functions, Chest Expansion, Asthma Control, Dyspnea
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Diaphragmatic Release TechniqueOther
Also called Generalized body stretching
Manual Diaphragmatic Breathing Technique, 2 sets with a 5 min rest interval between sets will be given, patient will lie supine in a relaxed position, Therapist will stand behind the patients head with the therapist forearm aligned towards patient shoulders, the hypothenar and the last three fingers of therapist hand will make contact bilaterally with underside of 7th, 8th, 9th, and 10th ribs costal cartilages, Patient is instructed to inhale deeply, therapist will pull the contact sites towards head and slightly in a lateral direction, during expiration therapist increases the contact depth beneath costal margins and maintain the resistance, therapist will continue to increase the depth of contact in the coming deep breath. Initially patient will be asked to take 5 deep breath/ set in the first week then it will progress to 10 deep breaths in the second,third and fourth week.
Chest Wall Expansion ExercisesOther
Also called Generalized Body Stretching
Four different types of chest exercises will be given to second group for 2-3 days/week for 4 weeks along with generalized body stretching
| Study group | Role | What they receive |
|---|---|---|
| Manual Diaphragmatic Release Technique | Experimental | Manual Diaphragmatic Release Technique and Generalized Body Stretching Receives: Other: Manual Diaphragmatic Release Technique |
| Chest Wall Expansion Exercises | Experimental | Chest Wall Expansion Exercises and generalized Body stretching Receives: Other: Chest Wall Expansion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function
Changes from baseline Pulmonary function test will be measured through Digital SpirometerDigital Spirometer is a hand held device that measures Forced Expiratory Volume 1 (FEV1) in the first second patient exhale and Forced Vital Capacity (FVC).
Measured: 4th week
Chest Expansion
Changes from baseline Chest expansion is measured by using a measuring tape at 2 different levels of rib cage, upper chest expansion is measured at the third intercostal space at the level of clavicular line and spinous process of fifth thoracic vertebra. Lower chest expansion is measured at the tip of xiphoid process and the spinous process of tenth thoracic vertebra measurements will be taken at the end of deep inspiration and expiration.
Measured: 4th week
Secondary outcomes (2)
Asthma Control Test
Changes from baseline will be measured through Asthma Control Test (ACT) is a questionnaire that consists of 5 questions on a scale from 1 to 5 of symptoms. The questions are about limitations due to asthma and symptoms in the past 4 week. A lower score then 19 corresponds with poor asthma control.
Measured: 4th week
Modified Borg Scale
Changes from baseline will be measured through The modified Borg scale is an 11-point numerical scale rating the difficulty of breathing from "breathing is causing no difficulty at all" (zero point) to "breathing difficulty is maximal" (10 points).
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat ul-Ain, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460857
- Sponsor's protocol ID
- REC/46984 Khadija Ghafoor
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmad AM, Nawar NM, Dabess HM, Gallab MA. Effect of diaphragm manual release versus conventional breathing exercises and prone positioning on physical functional performance in women with COVID-19: A randomized trial. J Bodyw Mov Ther. 2023 Jul;35:311-319. doi: 10.1016/j.jbmt.2023.04.064. Epub 2023 Apr 21.
PubMed 37330786Kim H, Mazza J. Asthma. Allergy Asthma Clin Immunol. 2011 Nov 10;7 Suppl 1(Suppl 1):S2. doi: 10.1186/1710-1492-7-S1-S2.
PubMed 22165976Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
PubMed 15080825Aslam R, Sharif F, Baqar M, Nizami AS, Ashraf U. Role of ambient air pollution in asthma spread among various population groups of Lahore City: a case study. Environ Sci Pollut Res Int. 2023 Jan;30(4):8682-8697. doi: 10.1007/s11356-022-19086-1. Epub 2022 Feb 26.
PubMed 35220536Hill AR. Respiratory muscle function in asthma. J Assoc Acad Minor Phys. 1991;2(3):100-8.
PubMed 1809452Marcelino AM, da Cunha DA, da Cunha RA, da Silva HJ. Respiratory muscle strength in asthmatic children. Int Arch Otorhinolaryngol. 2012 Oct;16(4):492-6. doi: 10.7162/S1809-97772012000400010.
PubMed 25991978Decramer M, Lacquet LM, Fagard R, Rogiers P. Corticosteroids contribute to muscle weakness in chronic airflow obstruction. Am J Respir Crit Care Med. 1994 Jul;150(1):11-6. doi: 10.1164/ajrccm.150.1.8025735.
PubMed 8025735Tsimouris D, Arvanitidis M, Moutzouri M, Koumantakis GA, Gioftsos G, Papandreou M, Grammatopoulou E. Is manual therapy of the diaphragm effective for people with obstructive lung diseases? A systematic review. Respir Med Res. 2023 Jun;83:101002. doi: 10.1016/j.resmer.2023.101002. Epub 2023 Feb 15.
PubMed 37027895Song GB, Park EC. Effects of chest resistance exercise and chest expansion exercise on stroke patients' respiratory function and trunk control ability. J Phys Ther Sci. 2015 Jun;27(6):1655-8. doi: 10.1589/jpts.27.1655. Epub 2015 Jun 30.
PubMed 26180292Mohan V, Aziz KB, Kamaruddin K, Leonard JH, Das S, Jagannathan MG. Effect of intercostal stretch on pulmonary function parameters among healthy males. EXCLI J. 2012 Jun 15;11:284-90. eCollection 2012.
PubMed 27418905Basith A, Suganthirababu P, Srinivasan V, Kumaresan A, Vishnuram S, Priyadharshini K. A Comparative on the Effects of Thoracic Squeeze Technique Versus Manual Diaphragm Release Technique on Sputum Clearance among Patient with Chronic Obstructive Pulmonary Disease. Indian Journal of Physiotherapy & Occupational Therapy. 2024;18.
Thali SM, Ganesh B. Comparison of Diaphragmatic Stretch and Manual Diaphragmatic Release Technique Along with Chest Proprioceptive Neuromuscular Facilitation in Mild-to-moderate Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. Indian Journal of Physical Therapy and Research. 2023;5(2):169-75.
Ghallab MA, Salman AF, Nawar NM, Saafan KI, Mostafa AI, Kelini KIS, et al. Influence of manual diaphragm release combined with conventional breathing exercises and prone positioning on pulmonary functions in women with Covid-19. Revista iberoamericana de psicología del ejercicio y el deporte. 2024;19(1):83-8.
Abd El-Rahem ZM, Yamany AA, Grase MO, Moawad M. EFFECT OF DIAPHRAGMATIC RELEASE ON NECK PAIN AND CHEST EXPANSION IN PATIENTS WITH UPPER CROSSED SYNDROME.
Nagy EN, Elimy DA, Ali AY, Ezzelregal HG, Elsayed MM. Influence of Manual Diaphragm Release Technique Combined with Inspiratory Muscle Training on Selected Persistent Symptoms in Men with Post-Covid-19 Syndrome: A Randomized Controlled Trial. J Rehabil Med. 2022 Oct 20;54:jrm00330. doi: 10.2340/jrm.v54.3972.
PubMed 36121338
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Diaphragmatic Release Technique Versus Chest Wall Expansion Exercises on Pulmonary Function, Chest Wall Expansion and Asthma Control in Patients With Asthma
- ClinicalTrials.gov ID
- NCT06460857
- Acronym / sponsor ID
- REC/46984 Khadija Ghafoor
- Conditions
- Asthma
- Keywords
- Manual Diaphragmatic Release Technique, Chest Wall Expansion Exercises, Pulmonary Functions, Chest Expansion, Asthma Control, Dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 14 Jun 2024 (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.
To determine the effects of manual diaphragmatic release technique (MDRT) versus chest wall expansion exercises on pulmonary function, chest wall expansion and asthma control in patients with asthma.
Detailed description
Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as A for Group A and B for group B. At the beginning of the study, a formal educational session, lasting about 30 minutes will be given by the physiotherapist dealing with the treatment/interventions.
Group A: It will receive MDRT and generalized body stretching. Group B: It will receive Chest Expansion Exercises and generalized body stretching.
Frequency of patient's visit will be tailored with minimum of 2-3 visits per week for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Diaphragmatic Release Technique | Experimental | Other: Manual Diaphragmatic Release TechniqueManual Diaphragmatic Release Technique and Generalized Body Stretching |
| Chest Wall Expansion Exercises | Experimental | Other: Chest Wall Expansion ExercisesChest Wall Expansion Exercises and generalized Body stretching |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Medically diagnosed asthma patients.
Key exclusion criteria (4 listed)
- • Patients having other cardiac or respiratory diseases.
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 Diaphragmatic Release TechniqueAlso: Generalized body stretchingManual Diaphragmatic Breathing Technique, 2 sets with a 5 min rest interval between sets will be given, patient will lie supine in a relaxed position, Therapist will stand behind the patients head with the therapist forearm aligned towards patient shoulders, the hypothenar and the last three fingers of therapist hand will make contact bilaterally with underside of 7th, 8th, 9th, and 10th ribs costal cartilages, Patient is instructed to inhale deeply, therapist will pull the contact sites towards head and slightly in a lateral direction, during expiration therapist increases the contact depth beneath costal margins and maintain the resistance, therapist will continue to increase the depth of contact in the coming deep breath. Initially patient will be asked to take 5 deep breath/ set in the first week then it will progress to 10 deep breaths in the second,third and fourth week. | Other | Manual Diaphragmatic Release Technique |
| Chest Wall Expansion ExercisesAlso: Generalized Body StretchingFour different types of chest exercises will be given to second group for 2-3 days/week for 4 weeks along with generalized body stretching | Other | Chest Wall Expansion Exercises |
Primary outcome
Pulmonary Function
Time frame: 4th week
Changes from baseline Pulmonary function test will be measured through Digital SpirometerDigital Spirometer is a hand held device that measures Forced Expiratory Volume 1 (FEV1) in the first second patient exhale and Forced Vital Capacity (FVC).
Chest Expansion
Time frame: 4th week
Changes from baseline Chest expansion is measured by using a measuring tape at 2 different levels of rib cage, upper chest expansion is measured at the third intercostal space at the level of clavicular line and spinous process of fifth thoracic vertebra. Lower chest expansion is measured at the tip of xiphoid process and the spinous process of tenth thoracic vertebra measurements will be taken at the end of deep inspiration and expiration.
2 secondary outcomes
Asthma Control Test
Time frame: 4th week
Modified Borg Scale
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Background: PubMed 37330786Ahmad AM, Nawar NM, Dabess HM, Gallab MA. Effect of diaphragm manual release versus conventional breathing exercises and prone positioning on physical functional performance in women with COVID-19: A randomized trial. J Bodyw Mov Ther. 2023 Jul;35:311-319. doi: 10.1016/j.jbmt.2023.04.064. Epub 2023 Apr 21.
- Background: PubMed 22165976Kim H, Mazza J. Asthma. Allergy Asthma Clin Immunol. 2011 Nov 10;7 Suppl 1(Suppl 1):S2. doi: 10.1186/1710-1492-7-S1-S2.
- Background: PubMed 15080825Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
- Background: PubMed 35220536Aslam R, Sharif F, Baqar M, Nizami AS, Ashraf U. Role of ambient air pollution in asthma spread among various population groups of Lahore City: a case study. Environ Sci Pollut Res Int. 2023 Jan;30(4):8682-8697. doi: 10.1007/s11356-022-19086-1. Epub 2022 Feb 26.
- Background: PubMed 1809452Hill AR. Respiratory muscle function in asthma. J Assoc Acad Minor Phys. 1991;2(3):100-8.
- Background: PubMed 25991978Marcelino AM, da Cunha DA, da Cunha RA, da Silva HJ. Respiratory muscle strength in asthmatic children. Int Arch Otorhinolaryngol. 2012 Oct;16(4):492-6. doi: 10.7162/S1809-97772012000400010.
- Background: PubMed 8025735Decramer M, Lacquet LM, Fagard R, Rogiers P. Corticosteroids contribute to muscle weakness in chronic airflow obstruction. Am J Respir Crit Care Med. 1994 Jul;150(1):11-6. doi: 10.1164/ajrccm.150.1.8025735.
- Background: PubMed 37027895Tsimouris D, Arvanitidis M, Moutzouri M, Koumantakis GA, Gioftsos G, Papandreou M, Grammatopoulou E. Is manual therapy of the diaphragm effective for people with obstructive lung diseases? A systematic review. Respir Med Res. 2023 Jun;83:101002. doi: 10.1016/j.resmer.2023.101002. Epub 2023 Feb 15.
- Background: PubMed 26180292Song GB, Park EC. Effects of chest resistance exercise and chest expansion exercise on stroke patients' respiratory function and trunk control ability. J Phys Ther Sci. 2015 Jun;27(6):1655-8. doi: 10.1589/jpts.27.1655. Epub 2015 Jun 30.
- Background: PubMed 27418905Mohan V, Aziz KB, Kamaruddin K, Leonard JH, Das S, Jagannathan MG. Effect of intercostal stretch on pulmonary function parameters among healthy males. EXCLI J. 2012 Jun 15;11:284-90. eCollection 2012.
- BackgroundBasith A, Suganthirababu P, Srinivasan V, Kumaresan A, Vishnuram S, Priyadharshini K. A Comparative on the Effects of Thoracic Squeeze Technique Versus Manual Diaphragm Release Technique on Sputum Clearance among Patient with Chronic Obstructive Pulmonary Disease. Indian Journal of Physiotherapy & Occupational Therapy. 2024;18.
- BackgroundThali SM, Ganesh B. Comparison of Diaphragmatic Stretch and Manual Diaphragmatic Release Technique Along with Chest Proprioceptive Neuromuscular Facilitation in Mild-to-moderate Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. Indian Journal of Physical Therapy and Research. 2023;5(2):169-75.
- Individual participant dataSharing planned: No
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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.
Qurat ul-Ain principal investigator
Riphah International 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 Diaphragmatic Release Technique and Chest Wall Expansion Exercises in people with Asthma, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function (time frame: 4th week). The study lists 2 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 NCT06460857, which also lists 20 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 10 Jul 2024.