Exercise Rehabilitation for Children With Asthma

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise; Rehabilitation; Asthma in Children
• Intervention / Treatment: Behavioral: Personalized Exercise Rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention Control Group; The control group will not receive any specific intervention, continuing with their usual asthma management routine.
Experimental: Exercise Rehabilitation Group; The experimental group will participate in a 12-week exercise intervention program.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2024-IRB-0015-P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No