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NCT Number: NCT06272604

Exercise Rehabilitation for Children With Asthma

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.

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Key information

Conditions

Asthma in Children Behavior Exercise Motor Activity Rehabilitation

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Personalized Exercise Rehabilitation

Behavioral

The experimental group will participate in a 12-week exercise intervention program, carefully transitioning from moderate-intensity interval training to high-intensity interval training. The progression of exercise intensity will be regularly adjusted based on each child's tolerance, ensuring a personalized approach to the regimen. The exercise program is structured into three phases: an adaptation phase, an intensification phase, and a consolidation phase. For each participant, the intensity of the exercises is calculated based on their reserve heart rate, allowing for a tailored and scientifically-grounded progression. This approach aims to optimize the exercise program's effectiveness while maintaining safety and adaptability to individual fitness levels and asthma conditions.

Primary outcomes

  1. Lung Function

    Time frame: up to 24 weeks

    Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1), Forced Expiratory Flow 25% to 75% (FEF25-75), Peak Expiratory Flow (PEF)

  2. Daily Physical Activity Level

    Time frame: up to 24 weeks

    Daily Step Count (as measured by a pedometer), Energy Expenditure,Time Spent in Moderate-to-Vigorous Intensity Activity

Secondary outcomes

  1. Asthma Control Status

    Time frame: up to 24 weeks

    asthma control test(ACT)

  2. Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: up to 12 weeks

    FeNO was determined by NIOX VERO

  3. Body Composition

    Time frame: up to 24 weeks

    Height, Weight, Body Fat, Skeletal Muscle Content

  4. Sleep

    Time frame: up to 24 weeks

    Number of Nighttime Awakenings, Sleep Duration

  5. Health Related Quality of Life

    Time frame: up to 24 weeks

    Asthma Quality of Life Questionnaire

  6. Anxiety and Depression

    Time frame: up to 24 weeks

    C-C-Ped-PROMIS

  7. Inflammatory Mediators

    Time frame: up to 12 weeks

    IL-4, IL-5, IL-13

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Personalized Exercise Rehabilitation for Pediatric and Adolescent Asthma: A Comprehensive Intervention Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 22, 2024
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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