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临床试验/NCT07397676
NCT07397676进行中(未招募)不适用

Effects of Breathing Technique Training and Physical Activity Counseling on Quality of Life, Symptoms, Asthma Control, and Physical Activity in Children and Adolescents With Asthma: A Randomized Controlled Trial

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Paediatric Asthma Quality of Life Questionnaire

研究概览

简要总结

Many children and adolescents with asthma have dysfunctional breathing, e.g. they use mainly upper chest muscles to breath and do not engage the diaphragma muscle when breathing. This can lead to a variety of breathin problems such as dizzyness, muscle tension, and limitations in ability to be physically active. As of today there is no guidelines for treatment or follow-up for these patients and there are very few well-perfomed studies evaluating if breathin retraining can improve breathing pattern.

The aim of this study is to examine the effects of breathing training and advice on physical activity compared to only advice on physical activity in children and adolescents with asthma. The primary outcome is quality of life and secondary outcomes are dysfunctional breathing, asthma control, physical activity level and spirometry changes.

This randomized controlled trial.

Patients are identified at the paediatric lung clinic at Karolinska University Hospital, and patients aged 10-17 years who are reffered to see a physiotherapist for spirometry and exercise testing who have with asthma who have dysfunctional breathing are invited to participate.

Assessments include the Paediatric Asthma Quality of Life Questionnaire, Parent Asthma Quality of Life Questionnaire, The Paediatric Nijmegen Questionnaire assessing symtpoms associated to dysfunctional breathing, the Childhood Asthma control test or the adult asthma control test. These questionnaires as completed by patients with or without their parents depending on their age at baseline, and after 4 weeks, 12 weeks and 24 weeks. At baseline and after 4 weeks an exercise tolerance test of 8 minutes performed on a treadmill and spirometry are performed.

Interventions:

Acitve intervention means diaphragmal breathing training 5 days a week for

详细描述

Study Protocol for ClinicalTrials.gov

Study Title Effects of Breathing Technique Training and Physical Activity Counseling on Quality of Life, Symptoms, Asthma Control, and Physical Activity in Children and Adolescents With Asthma: A Randomized Controlled Trial

Brief Summary This randomized controlled trial aims to evaluate the effects of training in low-costal and diaphragmatic breathing techniques combined with counseling on physical activity according to FYSS, compared with standard care-physical activity counseling according to FYSS alone-on quality of life, symptoms related to dysfunctional breathing, asthma control, and physical activity levels in children and adolescents with asthma.

Approximately 70 patients referred to a physical therapist at Karolinska University Hospital (Huddinge and Solna) will be invited to participate over one year. Participants will be randomized to either (1) an intervention group receiving extended physiotherapy including breathing training, inhalation technique, and individualized physical activity advice, or (2) a control group receiving standard physical activity recommendations according to FYSS.

The primary outcome is health-related quality of life measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 10-17, diagnosis of atopic and/or exercise-induced asthma, referred to physiotherapy.

排除标准

  • Completely symptom-free patients, not understanding Swedish language

研究组 & 干预措施

Breathing retraining and advice on physical activity

Experimental

5 minutes of daily diaphragma breathing training, three times per day for 4 weeks

干预措施: Breathing training (Other)

Breathing retraining and advice on physical activity

Experimental

5 minutes of daily diaphragma breathing training, three times per day for 4 weeks

干预措施: Standrad advice about physical activity (Other)

Standard advice about physical activity

Active Comparator

Written and oral advice about physical activity at baseline

干预措施: Standrad advice about physical activity (Other)

结局指标

主要结局

Paediatric Asthma Quality of Life Questionnaire

时间窗: Change from baseline in quality of life at 4 weeks. Follow-up at 12 and 24 weeks

Self-reported quality of life in three domains; Asthma symptoms, Activity limitation and Emotional. Contains 32 items. Completed on paper.

Paediatric Asthma Quality of Life Questionnaire

时间窗: Assessed at baseline, after 4 weeks of intervention, at 12 weeks and 24 weeks follow-up

Self-reported quality of life in three domains - symptoms, activity limitation and emotional

次要结局

  • Paediatric Nijmegen Questionnaire(Change from baseline in breathing problems at 4 weeks, with follow-up at 12 and 24 weeks)
  • Saltin-Grimby Physical Activity Scale(Changes from baseline in physical activity levels at 4 weeks with follow-up at 12 and 24 weeks)
  • Childhood / Adult Asthma Control Test (c-ACT / ACT)(Changes from baseline after 4 weeks of intervention, follow-up at 12 and 24 weeks)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helene Alexanderson

Associate professor, PhD, RPT

Karolinska University Hospital

研究点 (1)

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