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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728191
• Other study ID #: S-20200101-b
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Kolding Sygehus
• Contact: Signe Vahlkvist, PhD
• Phone: +45 20 23 14 30
• Email: Signe.Vahlkvist[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Dysfunctional Breathing
• Respiratory Aspiration

Intervention

Other:
• Physiotherapy
physiotherapeutical instructions and training as described.
• standard care
Standard care as described.

Locations

Country	Name	City	State
Denmark	Signe Vahlkvist	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Kolding Sygehus	Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.