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The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Experimental: Diaphragmatic Manual Therapy Group A
Sham Breathing Retraining Exercises Group B
Sponsored by
University of West Attica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Diaphragm, Breathing retraining, Physiotherapy, Manual therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 - 60 years Diagnosed with well controlled asthma (mild, moderate-severe) using spirometry No acute exacerbation in the last two months Exclusion Criteria: 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.

Sites / Locations

  • Dimitrios TsimourisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Diaphragmatic excursion assessment with Ultrasonography

Chest wall expansion

Nijmegen Questionnaire

Asthma Control Test

Sf-12v2 questionnaire

Borg scale

Arm Description

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.

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.

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.

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.

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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
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

Full Information

First Posted
January 23, 2023
Last Updated
May 8, 2023
Sponsor
University of West Attica
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1. Study Identification

Unique Protocol Identification Number
NCT05709054
Brief Title
The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma
Official Title
The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma: Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Diaphragm, Breathing retraining, Physiotherapy, Manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic excursion assessment with Ultrasonography
Arm Type
Experimental
Arm Description
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.
Arm Title
Chest wall expansion
Arm Type
Experimental
Arm Description
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.
Arm Title
Nijmegen Questionnaire
Arm Type
Experimental
Arm Description
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.
Arm Title
Asthma Control Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Sf-12v2 questionnaire
Arm Type
Experimental
Arm Description
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
Arm Title
Borg scale
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Experimental: Diaphragmatic Manual Therapy Group A
Intervention Description
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: 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.
Intervention Type
Other
Intervention Name(s)
Sham Breathing Retraining Exercises Group B
Intervention Description
Sham 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.
Primary Outcome Measure Information:
Title
Diaphragmatic excursion assessment with Ultrasonography
Description
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.
Time Frame
Change from baseline up to 6 weeks and up to 3 months
Title
Chest wall expansion
Description
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.
Time Frame
Change from baseline up to 6 weeks and up to 3 months
Secondary Outcome Measure Information:
Title
Nijmegen Questionnaire
Description
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
Time Frame
Change from baseline up to 6 weeks and up to 3 months
Title
Asthma Control Test
Description
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.
Time Frame
Change from baseline up to 6 weeks and up to 3 months
Title
Sf-12v2 questionnaire
Description
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
Time Frame
Change from baseline up to 6 weeks and up to 3 months
Title
Borg scale
Description
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
Time Frame
Change from baseline up to 6 weeks and up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 - 60 years Diagnosed with well controlled asthma (mild, moderate-severe) using spirometry No acute exacerbation in the last two months Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DIMITRIOS TSIMOURIS, PhD candidate
Phone
6987415996
Email
dtsimouris@uniwa.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Eirini Grammatopoulou, Prof.
Email
eirinigrammat@gmail.com
Facility Information:
Facility Name
Dimitrios Tsimouris
City
Ilion
State/Province
Attiki
ZIP/Postal Code
13672
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DIMITRIOS TSIMOURIS, PhDc.
Phone
6987415996
Email
dtsimouris@uniwa.gr

12. IPD Sharing Statement

Citations:
PubMed Identifier
30719351
Citation
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.
Results Reference
background
PubMed Identifier
26386894
Citation
Rocha 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.
Results Reference
background
PubMed Identifier
29672230
Citation
Greising 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.
Results Reference
background
PubMed Identifier
11376510
Citation
Mergoni M, Rossi A. [Physiopathology of acute respiratory failure in COPD and asthma]. Minerva Anestesiol. 2001 Apr;67(4):198-205. Italian.
Results Reference
background
PubMed Identifier
32212422
Citation
Santino 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.
Results Reference
background
PubMed Identifier
21668321
Citation
Grammatopoulou 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.
Results Reference
background
PubMed Identifier
31337743
Citation
Elnaggar 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.
Results Reference
background
PubMed Identifier
30686657
Citation
Vetrugno 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.
Results Reference
background
Citation
Enrique 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
Results Reference
background
Links:
URL
http://www.phys.uniwa.gr/
Description
The Physiotherapy Department of the University of West Attica in Athens, responsible for the coordination of the trial.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://doi.org/10.1016/j.ijosm.2018.07.006

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The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma

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