Exercise Rehabilitation for Children With Asthma

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272604
• Other study ID #: 2024-IRB-0015-P-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: February 2024
• Source: The Children's Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Exercise
• Rehabilitation

Intervention

Behavioral:
• Personalized Exercise Rehabilitation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Children's Hospital of Zhejiang University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function	Forced Vital Capacity (FVC), Forced Expiratory Volume in One Second (FEV1), Forced Expiratory Flow 25% to 75% (FEF25-75), Peak Expiratory Flow (PEF)	up to 24 weeks
Primary	Daily Physical Activity Level	Daily Step Count (as measured by a pedometer), Energy Expenditure,Time Spent in Moderate-to-Vigorous Intensity Activity	up to 24 weeks
Secondary	Asthma Control Status	asthma control test(ACT)	up to 24 weeks
Secondary	Fractional Exhaled Nitric Oxide (FeNO)	FeNO was determined by NIOX VERO	up to 12 weeks
Secondary	Body Composition	Height, Weight, Body Fat, Skeletal Muscle Content	up to 24 weeks
Secondary	Sleep	Number of Nighttime Awakenings, Sleep Duration	up to 24 weeks
Secondary	Health Related Quality of Life	Asthma Quality of Life Questionnaire	up to 24 weeks
Secondary	Anxiety and Depression	C-C-Ped-PROMIS	up to 24 weeks
Secondary	Inflammatory Mediators	IL-4, IL-5, IL-13	up to 12 weeks