The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma

The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma.

The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma.

Children and adolescents with dysfunctional breathing, are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control ( if asthma) and quality of life.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Asthma in Children; Dysfunctional Breathing
• Intervention / Treatment: Other: Physiotherapy; Other: standard care

Detailed Description

The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma.

All children and adolescents aged 10-17 years, followed in our outpatient clinic with the diagnose of asthma are invited to fulfill the Nijmegen Questionnaire (NQ) and the Asthma Control Questionnaire (ACQ5)

Children and adolescents where asthma was investigated and ruled out are invited to fulfill the NQ.

Data from the electronic patient journal are used as descriptives.

Participants with dysfunctional breathing (NQ >= 23) are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control measured by ACQ5 (if asthma) and quality of life measured by PedsQL.

The effect of physiotherapy is analyzed separately for participants with and without asthma. In addition, primary outcomes are analyzed in a regression model with asthma status, age and sex as explanatory variables.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Signe Vahlkvist, PhD; Phone Number: +45 20 23 14 30; Email: Signe.Vahlkvist@rsyd.dk
• Study Contact Backup: Name: Louise Jürgensen, MD; Email: Anne.louise.Jürgensen@rsyd.dk

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Recruiting
    • Signe Vahlkvist
    • Contact: Louise Jürgensen, MD; Email: Anne.louise.Jürgensen@rsyd.dk
    • Contact: Signe Vahlkvist, PhD; Email: Signe.Vahlkvist@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Asthma group:

• Asthma diagnosed by lung function tests and/or typical symptoms.
• Treatment with inhaled corticosteroids in minimum 3 months.
• ACQ5 >= 1.5.
• NQ >= 23.

NonAsthma group

• Asthma denied after lung function tests ( exercise challenge or mannitol challenge)
• NQ >= 23.

Exclusion Criteria:

• Other significant cardiopulmonary or muscoluskeletal conditions.
• Complex functional conditions involving other organ systems.
• patients who already had the physotherapeutical intervention before study start.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: + asthma + intervention; 35 participants with asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.	Other: Physiotherapy; physiotherapeutical instructions and training as described.
Active Comparator: + asthma - intervention; 35 participants with asthma aged 10-17 years, randomized to standard care. Participants are getting advice about dysfunctional breathing by a physician or nurse in the outpatient clinic.	Other: standard care; Standard care as described.
Experimental: - asthma + intervention; 35 participants without asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.	Other: Physiotherapy; physiotherapeutical instructions and training as described.
Active Comparator: - asthma - intervention; 35 participants without asthma, which are randomized to standard care. Participants are getting advise about dysfunctional breathing by a physician or nurse in the outpatient clinic.	Other: standard care; Standard care as described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.	ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma, at visits in the outpatient clinic.	ACQ is taken at baseline and 6 months after intervention as primary outcome.
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months	PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 8-12 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows: 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as a mean of scores. Psychosocial Health summary score is calculated as a mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated as physical functioning scale score mean.	PedsQL is taken at baseline and 6 months after intervention as primary outcome.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Nijmegen Questionnaire ( NQ)	NQ consists of 16 questions regarding dysfunctional breathing. Each question is scored between 0-4 points, where 0 is best and 4 is worst.	NQ is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)	BBPAT is a breathing scoring equipment where an observer is scoring the quality of breathing from seven parameters including respiratory rate, respiratory movements, in and expiratory sounds etc. Each parameter is scored from 0 ( best) to 2 ( worst). Total score is calculated between 0-14 point	BBPAT is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Number of contacts to the hospital during one year from baseline	Number of total contacts includes planned visits, extra visits and hospitalisations	from baseline to 12 months after intervention.
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.	ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma in the outpatient clinic at baseline and after 6 weeks, 6 months and 12 months.	ACQ5 is taken at 6 weeks and 12 months after intervention as secondary outcomes.
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at at 6 weeks and one year. Change from 6 months in PedsQl at 12 months.	PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 10-13 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows. 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as mean of scores. Psychosocial Health summary score is calculated as mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated physical functioning scale score mean.	PedsQl is taken at 6 weeks and 12 months after intervention as secondary outcomes.
The reported use of rescue Beta2 agonist in puffs per week	The reported use of short acting beta 2 agonist in puffs per week the last week.	at baseline and 6 weeks, 6 months and 12 months after intervention.

Collaborators and Investigators

• Sponsor: Kolding Sygehus
• Collaborators: Odense Patient Data Explorative Network
• Investigators: Principal Investigator: Signe Vahlkvist, PhD, Kolding Sygehus

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Physiotherapy; Dysfunctional breathing; Asthma in children; Asthma in adolescents
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: S-20200101-b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie published results, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to Open@rsyd.dk.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No