Exercise Rehabilitation for Children With Asthma

NCT06272604 | Not Yet Recruiting

• 1 other identifier: 2024-IRB-0015-P-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Asthma Control Status

  up to 24 weeks

• Fractional Exhaled Nitric Oxide (FeNO)

  up to 12 weeks

• Body Composition

  up to 24 weeks

• Sleep

  up to 24 weeks

• Health Related Quality of Life

  up to 24 weeks

Study Arms (2)

No Intervention Control Group

NO INTERVENTION

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

Exercise Rehabilitation Group

EXPERIMENTAL

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

Behavioral: Personalized Exercise Rehabilitation

Interventions

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.

Exercise Rehabilitation Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 22, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 22, 2024

Record last verified: 2024-02