AsthmaNCT05709054
The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma
A study testing Experimental: Diaphragmatic Manual Therapy Group A in people with Asthma, run by University of West Attica at 1 site in Greece.
Trial summary
The mechanical alterations related to the overload of respiratory muscles observed in people with persistent asthma can lead to the development of musculoskeletal dysfunctions. Moreover, the produced lung hyperinflation and high lung volumes in the asthma crisis put the diaphragm at a disadvantage in terms of its… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Experimental: Diaphragmatic Manual Therapy Group A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2023to 1 Jan 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 - 60 years
- Diagnosed with well controlled asthma (mild, moderate-severe) using spirometry
- No acute exacerbation in the last two months
Who cannot join
- Cardiopulmonary diseases
- Previous cardiothoracic or abdominal surgery
- Patients who have a recent history of the chest wall or abdominal trauma
- Patients with unstable hemodynamic parameters (arterial pressure >140mmHg systolic and >90mmHg for diastolic inability to understand the verbal commands necessary for the outcome assessments
- Pregnancy
- Neurological diseases
- Previous or parallel participation in interventional programs.
Trial locations and contacts
1 site in 1 country.
Eirini Grammatopoulou, Prof. contact
Greece1 site, 1 recruiting
- Recruiting
Dimitrios Tsimouris
Nea Liosia, Attica, 13672
DIMITRIOS TSIMOURIS, PhDc., 6987415996, dtsimouris@uniwa.gr
About this study
Official title: The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma: Protocol for a Randomized Controlled Trial
The mechanical alterations related to the overload of respiratory muscles observed in people with persistent asthma can lead to the development of musculoskeletal dysfunctions. Moreover, the produced lung hyperinflation and high lung volumes in the asthma crisis put the diaphragm at a disadvantage in terms of its length-tension curve and lowered its excursion and capacity to generate force. According to a preliminary study, manual therapy (MT) techniques can be used as adjunctive therapy in asthma treatment. The proposed protocol is the first randomized controlled clinical trial to assess MT's efficacy on the diaphragm's ZOA in conjunction with BRE in individuals with well controlled mild moderate and severe asthma. Many musculoskeletal and respiratory outcomes will be used to investigate the under-study therapies' impact.
Read the detailed description
The diaphragm produces a craniocaudal movement of its dome during contraction, making it the most crucial breathing muscle due to its unique anatomical structure and contribution to minute ventilation (60%-80%). Patients with (COPD) or asthma often develop diaphragmatic dysfunction (DD). This DD is related to the mechanical linkage between its various parts, placing it at a mechanical disadvantage to the muscle fibers. The capacity of the diaphragm to elevate and extend the lower rib cage at the level of the zone of apposition is impaired by this pathological change. This change increases the work of breathing and weakens the diaphragm. People with moderate or severe asthma may experience pulmonary overstretching, which can lead to functional issues. How physiotherapy may increase the mechanical efficiency of the thoracic cage and the effectiveness of the respiratory muscles during breathing has been the main focus of studies in recent decades. Although the use of specific diaphragm MT techniques does not yet have sufficient research documentation, recently published studies reported that there are indications to support their positive effect on pulmonary rehabilitation. The efficacy of diaphragm MT methods has not been investigated in adults with asthma, although it has been investigated in pediatric asthma. The effect of diaphragms MT techniques in combination with BRE has not been investigated. The present study hypothesizes that the combination of the mentioned physiotherapy techniques will contribute positively to the length-tension relationship and mobility of the diaphragm and chest expansion in patients with asthma. Secondary positive improvements are expected in the domain of functionality, (b) the feeling of dyspnea, (c) disease control and (d) abnormal respiratory pattern. The amplification of the above in people with asthma using respiratory standards and applying diaphragm mobilization techniques will contribute to better disease management.
- Conditions
- Asthma
- Being tested
- Experimental: Diaphragmatic Manual Therapy Group A, Sham Breathing Retraining Exercises Group B
- Keywords
- Diaphragm, Breathing retraining, Physiotherapy, Manual therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Diaphragmatic Manual Therapy Group AOther
Experimental: Diaphragmatic Manual Therapy plus Breathing Retraining Exercises group:
Diaphragm manual therapy will be carried out and consists of a technique intended to stretch and mobilise the diaphragmatic muscle fibers indirectly. The maneuver will be performed in two sets of 10 repetitions, within a 1-minute interval for 10 minutes.
Breathing retraining exercises will be implemented for 30 minutes, consisting of:
- recognition of the abnormal breathing pattern ii) diaphragmatic breathing ii) nose breathing iii) slow breathing and controlled breath holding after exhalation iv) adaptation of the new breathing pattern in everyday life activities and various positions (supine, semi-sitting, sitting) v) breathing control in speech.
Sham Breathing Retraining Exercises Group BOther
Sham Breathing Retraining Exercises Group B:
Breathing retraining exercises will be implemented for 30 minutes, consisting of :
- recognition of the abnormal breathing pattern ii) diaphragmatic breathing ii) nose breathing iii) slow breathing and controlled breath holding after exhalation iv) adaptation of the new breathing pattern in everyday life activities and various positions (supine, semi-sitting, sitting) v) breathing control in speech.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic excursion assessment with Ultrasonography | Experimental | The time motion mode (M-mode) may be used to measure the diaphragm excursion in a curvilinear low-frequency transducer placed in the midclavicular line and angled in a cranial direction. Receives: Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B |
| Chest wall expansion | Experimental | The difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome. Receives: Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B |
| Nijmegen Questionnaire | Experimental | Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining. Receives: Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B |
| Asthma Control Test | Experimental | The ACT evaluates how well asthma affects daily functioning, and overall asthma control self-assessment. The score ranges from 5 (poor control of asthma) to 25 (well control of asthma). An ACT score >19 indicates well-controlled asthma. Receives: Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B |
| Sf-12v2 questionnaire | Experimental | With one or two questions per domain, it evaluates the exact eight health dimensions as the SF-36v2: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher ratings indicate better physical and mental well-functioning, ranging from 0 to 100. It has been suggested that a cut-off of 50 or less be used to identify a physical condition, while a score of 42 or less may signify clinical depression Receives: Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B |
| Borg scale | Experimental | The Borg dyspnea scale is a simple, scoring system extensively used to evaluate symptoms of shortness of breath and provides valuable data. It begins with 0, where you have no breathing problems, and rises to 10, where you have the most respiratory distress. As a result, healthcare professionals need to give patients enough time to learn and make sure they comprehend before using it Receives: Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion assessment with Ultrasonography
The M-mode line is placed at the posterior part of the diaphragm where there is maximal movement and excursion. On the right side, the liver acts as an acoustic window, and the diaphragm is easily identified as a hyperechoic curved line abutting the liver.
Measured: Change from baseline up to 6 weeks and up to 3 months
Chest wall expansion
By placing the tape measure at the level of the axilla (about the level of the sternal angle of Louis), the level of the xiphoid process, or between the xiphoid process and the umbilicus, the therapist identifies the upper, middle, and lower chest wall expansion, respectively. The therapist should repeat the measurement at least three times for each level for higher fidelity.
Measured: Change from baseline up to 6 weeks and up to 3 months
Secondary outcomes (4)
Nijmegen Questionnaire
Screening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining
Measured: Change from baseline up to 6 weeks and up to 3 months
Asthma Control Test
The ACT evaluates how well asthma affects daily functioning, and overall asthma control self-assessment. The score ranges from 5 (poor control of asthma) to 25 (well control of asthma). An ACT score >19 indicates well-controlled asthma.
Measured: Change from baseline up to 6 weeks and up to 3 months
Sf-12v2 questionnaire
With one or two questions per domain, it evaluates the exact eight health dimensions as the SF-36v2: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher ratings indicate better physical and mental well-functioning, ranging from 0 to 100. It has been suggested that a cut-off of 50 or less be used to identify a physical condition, while a score of 42 or less may signify clinical depression
Measured: Change from baseline up to 6 weeks and up to 3 months
Borg scale
The Borg dyspnea scale is a simple, scoring system extensively used to evaluate symptoms of shortness of breath and provides valuable data. It begins with 0, where you have no breathing problems, and rises to 10, where you have the most respiratory distress. As a result, healthcare professionals need to give patients enough time to learn and make sure they comprehend before using it
Measured: Change from baseline up to 6 weeks and up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DIMITRIOS TSIMOURIS, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709054
- Sponsor's protocol ID
- 90853/04-10-2022
- Status last verified
- May 2023
- First submitted
- 23 Jan 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
PubMed 30719351Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
PubMed 26386894Greising SM, Ottenheijm CAC, O'Halloran KD, Barreiro E. Diaphragm plasticity in aging and disease: therapies for muscle weakness go from strength to strength. J Appl Physiol (1985). 2018 Aug 1;125(2):243-253. doi: 10.1152/japplphysiol.01059.2017. Epub 2018 Apr 19.
PubMed 29672230Mergoni M, Rossi A. [Physiopathology of acute respiratory failure in COPD and asthma]. Minerva Anestesiol. 2001 Apr;67(4):198-205. Italian.
PubMed 11376510Santino TA, Chaves GS, Freitas DA, Fregonezi GA, Mendonca KM. Breathing exercises for adults with asthma. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD001277. doi: 10.1002/14651858.CD001277.pub4.
PubMed 32212422Grammatopoulou EP, Skordilis EK, Stavrou N, Myrianthefs P, Karteroliotis K, Baltopoulos G, Koutsouki D. The effect of physiotherapy-based breathing retraining on asthma control. J Asthma. 2011 Aug;48(6):593-601. doi: 10.3109/02770903.2011.587583. Epub 2011 Jun 13.
PubMed 21668321Elnaggar RK, Shendy MA, Mahmoud MZ. Prospective Effects of Manual Diaphragmatic Release and Thoracic Lymphatic Pumping in Childhood Asthma. Respir Care. 2019 Nov;64(11):1422-1432. doi: 10.4187/respcare.06716. Epub 2019 Jul 23.
PubMed 31337743Vetrugno L, Guadagnin GM, Barbariol F, Langiano N, Zangrillo A, Bove T. Ultrasound Imaging for Diaphragm Dysfunction: A Narrative Literature Review. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2525-2536. doi: 10.1053/j.jvca.2019.01.003. Epub 2019 Jan 4.
PubMed 30686657Enrique Leonés-Macías, Irene Torres-Sánchez∗ , Irene Cabrera-Martos, Araceli Ortiz-Rubio, Laura López-López, Marie Carmen Valenza. Effects of manual therapy on the diaphragm in asthmatic patients: A randomized pilot study. International Journal of Osteopathic Medicine; International Journal of Osteopathic Medicine 29 (2018) 26-31DOI: 10.1016/j.ijosm.2018.07.006
Tsimouris D, Grammatopoulou E, Papandreou M, Gioftsos G, Koumantakis G. The effect of manual therapy on diaphragm function in adults with asthma: Protocol for a randomized controlled trial. F1000Res. 2024 Mar 19;12:1361. doi: 10.12688/f1000research.141455.2. eCollection 2023.
PubMed 39359613
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05709054
- Acronym / sponsor ID
- 90853/04-10-2022
- Conditions
- Asthma
- Keywords
- Diaphragm, Breathing retraining, Physiotherapy, Manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 1 Feb 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.
The mechanical alterations related to the overload of respiratory muscles observed in people with persistent asthma can lead to the development of musculoskeletal dysfunctions. Moreover, the produced lung hyperinflation and high lung volumes in the asthma crisis put the diaphragm at a disadvantage in terms of its length-tension curve and lowered its excursion and capacity to generate force. According to a preliminary study, manual therapy (MT) techniques can be used as adjunctive therapy in asthma treatment. The proposed protocol is the first randomized controlled clinical trial to assess MT's efficacy on the diaphragm's ZOA in conjunction with BRE in individuals with well controlled mild moderate and severe asthma. Many musculoskeletal and respiratory outcomes will be used to investigate the under-study therapies' impact.
Detailed description
The diaphragm produces a craniocaudal movement of its dome during contraction, making it the most crucial breathing muscle due to its unique anatomical structure and contribution to minute ventilation (60%-80%). Patients with (COPD) or asthma often develop diaphragmatic dysfunction (DD). This DD is related to the mechanical linkage between its various parts, placing it at a mechanical disadvantage to the muscle fibers. The capacity of the diaphragm to elevate and extend the lower rib cage at the level of the zone of apposition is impaired by this pathological change. This change increases the work of breathing and weakens the diaphragm. People with moderate or severe asthma may experience pulmonary overstretching, which can lead to functional issues. How physiotherapy may increase the mechanical efficiency of the thoracic cage and the effectiveness of the respiratory muscles during breathing has been the main focus of studies in recent decades. Although the use of specific diaphragm MT techniques does not yet have sufficient research documentation, recently published studies reported that there are indications to support their positive effect on pulmonary rehabilitation. The efficacy of diaphragm MT methods has not been investigated in adults with asthma, although it has been investigated in pediatric asthma. The effect of diaphragms MT techniques in combination with BRE has not been investigated. The present study hypothesizes that the combination of the mentioned physiotherapy techniques will contribute positively to the length-tension relationship and mobility of the diaphragm and chest expansion in patients with asthma. Secondary positive improvements are expected in the domain of functionality, (b) the feeling of dyspnea, (c) disease control and (d) abnormal respiratory pattern. The amplification of the above in people with asthma using respiratory standards and applying diaphragm mobilization techniques will contribute to better disease management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic excursion assessment with Ultrasonography | Experimental | Other: Experimental: Diaphragmatic Manual Therapy Group A, Other: Sham Breathing Retraining Exercises Group BThe time motion mode (M-mode) may be used to measure the diaphragm excursion in a curvilinear low-frequency transducer placed in the midclavicular line and angled in a cranial direction. |
| Chest wall expansion | Experimental | Other: Experimental: Diaphragmatic Manual Therapy Group A, Other: Sham Breathing Retraining Exercises Group BThe difference between the values obtained during deep inspiration and expiration will be determined by tape ruler (cm), high degrees represent better outcome, low degrees represent worse outcome. |
| Nijmegen Questionnaire | Experimental | Other: Experimental: Diaphragmatic Manual Therapy Group A, Other: Sham Breathing Retraining Exercises Group BScreening tool used to detect patients with hyperventilation complaints and DB patterns. Scores>20 are used as the cut-score to identify DB in patients with various conditions. NQ values in healthy individuals range from 10 to 12 ± 7 and values do tend to decrease towards these levels after breathing retraining. |
| Asthma Control Test | Experimental | Other: Experimental: Diaphragmatic Manual Therapy Group A, Other: Sham Breathing Retraining Exercises Group BThe ACT evaluates how well asthma affects daily functioning, and overall asthma control self-assessment. The score ranges from 5 (poor control of asthma) to 25 (well control of asthma). An ACT score >19 indicates well-controlled asthma. |
| Sf-12v2 questionnaire | Experimental | Other: Experimental: Diaphragmatic Manual Therapy Group A, Other: Sham Breathing Retraining Exercises Group BWith one or two questions per domain, it evaluates the exact eight health dimensions as the SF-36v2: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Higher ratings indicate better physical and mental well-functioning, ranging from 0 to 100. It has been suggested that a cut-off of 50 or less be used to identify a physical condition, while a score of 42 or less may signify clinical depression |
| Borg scale | Experimental | Other: Experimental: Diaphragmatic Manual Therapy Group A, Other: Sham Breathing Retraining Exercises Group BThe Borg dyspnea scale is a simple, scoring system extensively used to evaluate symptoms of shortness of breath and provides valuable data. It begins with 0, where you have no breathing problems, and rises to 10, where you have the most respiratory distress. As a result, healthcare professionals need to give patients enough time to learn and make sure they comprehend before using it |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 - 60 years
- Diagnosed with well controlled asthma (mild, moderate-severe) using spirometry
- No acute exacerbation in the last two months
Key exclusion criteria (7 listed)
- Cardiopulmonary diseases
- Previous cardiothoracic or abdominal surgery
- Patients who have a recent history of the chest wall or abdominal trauma
- Patients with unstable hemodynamic parameters (arterial pressure >140mmHg systolic and >90mmHg for diastolic inability to understand the verbal commands necessary for the outcome assessments
- Pregnancy
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 |
|---|---|---|
| Experimental: Diaphragmatic Manual Therapy Group AExperimental: Diaphragmatic Manual Therapy plus Breathing Retraining Exercises group: Diaphragm manual therapy will be carried out and consists of a technique intended to stretch and mobilise the diaphragmatic muscle fibers indirectly. The maneuver will be performed in two sets of 10 repetitions, within a 1-minute interval for 10 minutes. Breathing retraining exercises will be implemented for 30 minutes, consisting of: i) recognition of the abnormal breathing pattern ii) diaphragmatic breathing ii) nose breathing iii) slow breathing and controlled breath holding after exhalation iv) adaptation of the new breathing pattern in everyday life activities and various positions (supine, semi-sitting, sitting) v) breathing control in speech. | Other | Asthma Control Test, Borg scale, Chest wall expansion, Diaphragmatic excursion assessment with Ultrasonography, Nijmegen Questionnaire, Sf-12v2 questionnaire |
| Sham Breathing Retraining Exercises Group BSham Breathing Retraining Exercises Group B: Breathing retraining exercises will be implemented for 30 minutes, consisting of : i) recognition of the abnormal breathing pattern ii) diaphragmatic breathing ii) nose breathing iii) slow breathing and controlled breath holding after exhalation iv) adaptation of the new breathing pattern in everyday life activities and various positions (supine, semi-sitting, sitting) v) breathing control in speech. | Other | Asthma Control Test, Borg scale, Chest wall expansion, Diaphragmatic excursion assessment with Ultrasonography, Nijmegen Questionnaire, Sf-12v2 questionnaire |
Primary outcome
Diaphragmatic excursion assessment with Ultrasonography
Time frame: Change from baseline up to 6 weeks and up to 3 months
The M-mode line is placed at the posterior part of the diaphragm where there is maximal movement and excursion. On the right side, the liver acts as an acoustic window, and the diaphragm is easily identified as a hyperechoic curved line abutting the liver.
Chest wall expansion
Time frame: Change from baseline up to 6 weeks and up to 3 months
By placing the tape measure at the level of the axilla (about the level of the sternal angle of Louis), the level of the xiphoid process, or between the xiphoid process and the umbilicus, the therapist identifies the upper, middle, and lower chest wall expansion, respectively. The therapist should repeat the measurement at least three times for each level for higher fidelity.
4 secondary outcomes
Nijmegen Questionnaire
Time frame: Change from baseline up to 6 weeks and up to 3 months
Asthma Control Test
Time frame: Change from baseline up to 6 weeks and up to 3 months
Sf-12v2 questionnaire
Time frame: Change from baseline up to 6 weeks and up to 3 months
Borg scale
Time frame: Change from baseline up to 6 weeks and up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 30719351Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
- Background: PubMed 26386894Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
- Background: PubMed 29672230Greising SM, Ottenheijm CAC, O'Halloran KD, Barreiro E. Diaphragm plasticity in aging and disease: therapies for muscle weakness go from strength to strength. J Appl Physiol (1985). 2018 Aug 1;125(2):243-253. doi: 10.1152/japplphysiol.01059.2017. Epub 2018 Apr 19.
- Background: PubMed 11376510Mergoni M, Rossi A. [Physiopathology of acute respiratory failure in COPD and asthma]. Minerva Anestesiol. 2001 Apr;67(4):198-205. Italian.
- Background: PubMed 32212422Santino TA, Chaves GS, Freitas DA, Fregonezi GA, Mendonca KM. Breathing exercises for adults with asthma. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD001277. doi: 10.1002/14651858.CD001277.pub4.
- Background: PubMed 21668321Grammatopoulou EP, Skordilis EK, Stavrou N, Myrianthefs P, Karteroliotis K, Baltopoulos G, Koutsouki D. The effect of physiotherapy-based breathing retraining on asthma control. J Asthma. 2011 Aug;48(6):593-601. doi: 10.3109/02770903.2011.587583. Epub 2011 Jun 13.
- Background: PubMed 31337743Elnaggar RK, Shendy MA, Mahmoud MZ. Prospective Effects of Manual Diaphragmatic Release and Thoracic Lymphatic Pumping in Childhood Asthma. Respir Care. 2019 Nov;64(11):1422-1432. doi: 10.4187/respcare.06716. Epub 2019 Jul 23.
- Background: PubMed 30686657Vetrugno L, Guadagnin GM, Barbariol F, Langiano N, Zangrillo A, Bove T. Ultrasound Imaging for Diaphragm Dysfunction: A Narrative Literature Review. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2525-2536. doi: 10.1053/j.jvca.2019.01.003. Epub 2019 Jan 4.
- BackgroundEnrique Leonés-Macías, Irene Torres-Sánchez∗ , Irene Cabrera-Martos, Araceli Ortiz-Rubio, Laura López-López, Marie Carmen Valenza. Effects of manual therapy on the diaphragm in asthmatic patients: A randomized pilot study. International Journal of Osteopathic Medicine; International Journal of Osteopathic Medicine 29 (2018) 26-31DOI: 10.1016/j.ijosm.2018.07.006
- Derived from this study: PubMed 39359613Tsimouris D, Grammatopoulou E, Papandreou M, Gioftsos G, Koumantakis G. The effect of manual therapy on diaphragm function in adults with asthma: Protocol for a randomized controlled trial. F1000Res. 2024 Mar 19;12:1361. doi: 10.12688/f1000research.141455.2. eCollection 2023.
- The Physiotherapy Department of the University of West Attica in Athens, responsible for the coordination of the trial.Link provided by the sponsor.
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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.
Eirini Grammatopoulou, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Diaphragmatic Manual Therapy Group A in people with Asthma, run by University of West Attica at 1 site in Greece.
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 7 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 May 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 Greece. 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 DIMITRIOS TSIMOURIS, PhD candidate (6987415996, dtsimouris@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic excursion assessment with Ultrasonography (time frame: Change from baseline up to 6 weeks and up to 3 months). 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 NCT05709054, which also lists 10 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 May 2023.