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

NCT04728191 | Unknown

• 1 other identifier: S-20200101-b
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysfunctional Breathing; Asthma in Children; Asthma

Keywords

Dysfunctional breathing; Asthma in children; Asthma in adolescents; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change from baseline in Nijmegen Questionnaire ( NQ)

  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 taken at baseline and 6 weeks, 6 months and 12 months after intervention.

• Number of contacts to the hospital during one year from baseline

  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 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 is taken at 6 weeks and 12 months after intervention as secondary outcomes.

Study Arms (4)

+ asthma + intervention

EXPERIMENTAL

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

+ asthma - intervention

ACTIVE COMPARATOR

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

- asthma + intervention

EXPERIMENTAL

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

- asthma - intervention

ACTIVE COMPARATOR

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

Interventions

Physiotherapy OTHER

physiotherapeutical instructions and training as described.

+ asthma + intervention; - asthma + intervention

standard care OTHER

Standard care as described.

+ asthma - intervention; - asthma - intervention

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kolding Sygehus: lead
• Odense Patient Data Explorative Network: collaborator

Study Sites (1)

Signe Vahlkvist

Kolding, 6000, Denmark

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Physical Therapy Modalities; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Signe Vahlkvist, PhD

  Kolding Sygehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Signe Vahlkvist, PhD

CONTACT

+45 20 23 14 30; Signe.Vahlkvist@rsyd.dk

Louise Jürgensen, MD

CONTACT

Anne.louise.jürgensen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: February 10, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to Open@rsyd.dk.

Locations

DK (1)