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

NCT05709054 | Unknown

• 1 other identifier: 90853/04-10-2022
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Diaphragm; Breathing retraining; Physiotherapy; Manual therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline up to 6 weeks and up to 3 months

Secondary Outcomes (4)

• Nijmegen Questionnaire

  Change from baseline up to 6 weeks and up to 3 months

• Asthma Control Test

  Change from baseline up to 6 weeks and up to 3 months

• Sf-12v2 questionnaire

  Change from baseline up to 6 weeks and up to 3 months

• Borg scale

  Change from baseline up to 6 weeks and up to 3 months

Study Arms (6)

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.

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.

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.

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.

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

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

Other: Experimental: Diaphragmatic Manual Therapy Group A; Other: Sham Breathing Retraining Exercises Group B

Interventions

Experimental: Diaphragmatic Manual Therapy Group A OTHER

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.

Asthma Control Test; Borg scale; Chest wall expansion; Diaphragmatic excursion assessment with Ultrasonography; Nijmegen Questionnaire; Sf-12v2 questionnaire

Sham Breathing Retraining Exercises Group B OTHER

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.

Asthma Control Test; Borg scale; Chest wall expansion; Diaphragmatic excursion assessment with Ultrasonography; Nijmegen Questionnaire; Sf-12v2 questionnaire

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

Dimitrios Tsimouris

Nea Liosia, Attica, 13672, Greece

RECRUITING

Related Publications (10)

• 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.

  PMID: 30719351 BACKGROUND

• 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.

  PMID: 26386894 BACKGROUND

• 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.

  PMID: 29672230 BACKGROUND

• Mergoni M, Rossi A. [Physiopathology of acute respiratory failure in COPD and asthma]. Minerva Anestesiol. 2001 Apr;67(4):198-205. Italian.

  PMID: 11376510 BACKGROUND

• 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.

  PMID: 32212422 BACKGROUND

• 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.

  PMID: 21668321 BACKGROUND

• 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.

  PMID: 31337743 BACKGROUND

• 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.

  PMID: 30686657 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 39359613 DERIVED

Related Links

• The Physiotherapy Department of the University of West Attica in Athens, responsible for the coordination of the trial.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

DIMITRIOS TSIMOURIS, PhD candidate

CONTACT

6987415996; dtsimouris@uniwa.gr

Eirini Grammatopoulou, Prof.

CONTACT

eirinigrammat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

GR (1)