Quality of Life - Effects of a Physical Therapy Intervention to for Children and Adolescents With Asthma

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).

Detailed Description This study investigates whether adding structured breathing training to standard physical activity recommendations improves quality of life, dysfunctional breathing symptoms, asthma control, and physical activity levels among children and adolescents aged 10-17 with atopic and/or exercise-induced asthma.

Participants randomized to the intervention group will receive training in low-costal/diaphragmatic breathing, individualized physical activity advice, and inhalation technique training. Diaphragmatic breathing will be practiced 3 times per day for 3-5 minutes. The control group will receive standard physical activity advice based on FYSS guidelines.

Measurements will be taken before and after a 4-week intervention, and at 12- and 24-week follow-ups. Independent physiotherapists at each site will perform all assessments.

Study Design Study Type: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-blinded (Outcome Assessors) Primary Purpose: Treatment Estimated Enrollment: 63 participants Study Duration: 24 weeks follow-up Study Sites: Karolinska University Hospital, Huddinge and Solna

Interventions Intervention Group: Breathing Training + Physical Activity Counseling

• Low-costal/diaphragmatic breathing training (3×/day, 3-5 min)
• Inhalation technique training
• Individualized physical activity advice according to FYSS

Control Group: Standard Physical Activity Counseling (FYSS)

• Aerobic and muscle-strengthening recommendations
• For exercise-induced symptoms: ICS, bronchodilators, gradual warm-up

Outcome Measures Primary Outcome: PAQLQ Secondary Outcomes: Nijmegen Questionnaire, Actigraph accelerometry, ACT, spirometry, treadmill test.

Eligibility Criteria Inclusion: Age 10-17, diagnosis of atopic and/or exercise-induced asthma, referred to physiotherapy.

Exclusion: Completely symptom-free patients.

Study Procedures Baseline: PAQLQ, ACT, Nijmegen Questionnaire, Spirometry, Exercise Test, Accelerometer (14 days).

Intervention Period: 4 weeks. Follow-ups: Week 4, 12, 24.

Inclusion criteria

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

Exclusion criteria

• Completely symptom-free patients, not understanding Swedish language