Exercise Rehabilitation for Children With Asthma

Not Applicable

Not yet recruiting

• Conditions: Asthma in Children; Rehabilitation; Exercise
• Interventions: Behavioral: Personalized Exercise Rehabilitation

• Registration Number: NCT06272604
• Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Study Start: 2024-04-01
• Primary Completion: 2027-04-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Rehabilitation Group	Personalized Exercise Rehabilitation	The experimental group will participate in a 12-week exercise intervention program.

Primary Outcome Measures

Name	Time	Method
Daily Physical Activity Level	up to 24 weeks	Daily Step Count (as measured by a pedometer), Energy Expenditure,Time Spent in Moderate-to-Vigorous Intensity Activity
Lung Function	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)

Secondary Outcome Measures

Name	Time	Method
Asthma Control Status	up to 24 weeks	asthma control test(ACT)
Fractional Exhaled Nitric Oxide (FeNO)	up to 12 weeks	FeNO was determined by NIOX VERO
Anxiety and Depression	up to 24 weeks	C-C-Ped-PROMIS
Body Composition	up to 24 weeks	Height, Weight, Body Fat, Skeletal Muscle Content
Sleep	up to 24 weeks	Number of Nighttime Awakenings, Sleep Duration
Health Related Quality of Life	up to 24 weeks	Asthma Quality of Life Questionnaire
Inflammatory Mediators	up to 12 weeks	IL-4, IL-5, IL-13