Exercise Rehabilitation for Children With Asthma

NCT ID: NCT06272604

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-10-01

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.

Conditions

Asthma in Children; Rehabilitation; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

No Intervention Control Group

The control group will not receive any specific intervention, continuing with their usual asthma management routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise Rehabilitation Group

The experimental group will participate in a 12-week exercise intervention program.

Group Type: EXPERIMENTAL

Personalized Exercise Rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Nan Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2024-IRB-0015-P-01

Identifier Type: -

Identifier Source: org_study_id