Clinical trial NCT06272604: Exercise Rehabilitation for Children With Asthma
Official title: Personalized Exercise Rehabilitation for Pediatric and Adolescent Asthma: A Comprehensive Intervention Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma in Children
Rehabilitation
Exercise
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Asthma, a prevalent chronic condition among children and adolescents, substantially impairs their quality of life. In addressing this significant health concern, this study focuses on the potential of a customized exercise rehabilitation program tailored for this young demographic. By employing a randomized controlled trial design, the research aims to divide participants into two distinct groups: one undergoing a personalized exercise regimen and the other receiving standard medical care. The 12-week intervention for the exercise group includes a combination of aerobic activities, strength training, and targeted breathing exercises. The study's primary aim is to rigorously evaluate the impact of this specialized exercise protocol on critical health aspects such as lung function, physical endurance, frequency of asthma attacks, and overall quality of life. The anticipated findings from this research are expected to shed new light on effective asthma management strategies and offer invaluable guidance for clinical practices dedicated to improving health outcomes in young asthma patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with bronchial asthma;
2. No acute asthma attacks in the past three months;
3. Currently undergoing stable prophylactic treatment for asthma, with no changes in the treatment plan in the past three months.

Exclusion Criteria:

1. Suffering from other severe heart, lung, or musculoskeletal diseases;
2. Frequent acute asthma attacks or recent hospitalization records;
3. Changes in asthma medication treatment plan in the last three months;
4. Currently participating in other clinical trials that could affect the results of this study;
5. Any medical contraindications, such as severe exercise-induced asthma or other health issues affecting the ability to exercise;
6. Severe psychological or behavioral issues that may affect participation in training or adherence to the research protocol.

Primary outcomes:
measure: Lung Function
timeFrame: up to 24 weeks
measure: Daily Physical Activity Level
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Asthma Control Status
timeFrame: up to 24 weeks
measure: Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: up to 12 weeks
measure: Body Composition
timeFrame: up to 24 weeks
measure: Sleep
timeFrame: up to 24 weeks
measure: Health Related Quality of Life
timeFrame: up to 24 weeks
measure: Anxiety and Depression
timeFrame: up to 24 weeks
measure: Inflammatory Mediators
timeFrame: up to 12 weeks
Other outcomes:
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