Asthma in ChildrenNCT06272604
Exercise Rehabilitation for Children With Asthma
A study testing Personalized Exercise Rehabilitation in people with Asthma in Children and Rehabilitation, run by The Children's Hospital of Zhejiang University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children, Rehabilitation, Exercise
- What is being tested?
- Personalized Exercise Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Asthma in Children, Rehabilitation, Exercise
- Being tested
- Personalized Exercise Rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Exercise RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Personalized Exercise Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: up to 24 weeks
Secondary outcomes (7)
Asthma Control Status
asthma control test(ACT)
Measured: up to 24 weeks
Fractional Exhaled Nitric Oxide (FeNO)
FeNO was determined by NIOX VERO
Measured: up to 12 weeks
Body Composition
Height, Weight, Body Fat, Skeletal Muscle Content
Measured: up to 24 weeks
Sleep
Number of Nighttime Awakenings, Sleep Duration
Measured: up to 24 weeks
Health Related Quality of Life
Asthma Quality of Life Questionnaire
Measured: up to 24 weeks
Anxiety and Depression
C-C-Ped-PROMIS
Measured: up to 24 weeks
Inflammatory Mediators
IL-4, IL-5, IL-13
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Lin, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272604
- Sponsor's protocol ID
- 2024-IRB-0015-P-01
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Exercise Rehabilitation for Pediatric and Adolescent Asthma: A Comprehensive Intervention Study
- ClinicalTrials.gov ID
- NCT06272604
- Acronym / sponsor ID
- 2024-IRB-0015-P-01
- Conditions
- Asthma in Children, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Personalized Exercise RehabilitationThe experimental group will participate in a 12-week exercise intervention program. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Exercise RehabilitationThe 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. | Behavioural | Exercise Rehabilitation Group |
Primary outcome
Lung Function
Time frame: 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)
Daily Physical Activity Level
Time frame: up to 24 weeks
Daily Step Count (as measured by a pedometer), Energy Expenditure,Time Spent in Moderate-to-Vigorous Intensity Activity
7 secondary outcomes
Asthma Control Status
Time frame: up to 24 weeks
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: up to 12 weeks
Body Composition
Time frame: up to 24 weeks
Sleep
Time frame: up to 24 weeks
Health Related Quality of Life
Time frame: up to 24 weeks
Anxiety and Depression
Time frame: up to 24 weeks
Inflammatory Mediators
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Exercise Rehabilitation in people with Asthma in Children and Rehabilitation, run by The Children's Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Function (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.