Evaluating the effects of exercise on asthma control and quality of life among asthmatic children

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN10752161
• Date of registration: 13/11/2015
• Prospective Registration: No
• Primary sponsor: China Medical University
• Public title: Evaluating the effects of exercise on asthma control and quality of life among asthmatic children
• Scientific title: Effects of Physical Training on pulmonary function, inflammatory biomarkers, and sleep quality in non-obese CHildren with ASthma: A randomized control trial
• Date of first enrolment: 01/04/2010
• Target sample size: 62
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10752161
• Study type: Interventional
• Study design: Randomized controlled trial (Quality of life)

Countries of recruitment

Taiwan

Contacts

• Name: Yu-Kuei Teng

Key inclusion & exclusion criteria

Inclusion criteria: 1. Children aged between 6 and 12 years
2. Diagnosis of mild asthma by a physician based on the criteria of asthma symptoms and medical history
3. Having a methacholine test dose (PD20) of 8 mg/ml or less
4. Able to read and write
5. Having a score on the Asthma Control Test = 20 indicated ‘‘well-controlled’’ asthma
Exclusion criteria: 1. Any chronic disease, e.g. epilepsy, congenital heart disease, serious physical/psychiatric disorders, severe asthma, acute asthma exacerbations, obesity (body mass index above 95th percentile)
2. Children who had a regular exercise habit (who perform physical activity 3 or more sessions per week at moderate to vigorous intensity for 30 min or above)
3. Participating in any other clinical trials

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma
Respiratory
Asthma

Intervention(s)

Each child is randomly assigned to either the training group (asthma self-management education and physical activity training program) or the control group (asthma self-management education).

The self-management education program includes a two hour session providing information about asthma, self-monitoring (the importance of self-monitoring of peak expiratory flow rate), regular medical checks, and asthma management plan.

The physical training involves three sessions a week for a period of twelve weeks. Each session starts with a 10-15 minute warm-up period, followed by 30-40 minutes of moderate intensity physical training and a 10-15 minute cool-down period. Participants are encouraged to perform moderate intensity physical training at 60-75% of maximal heart rate (HRmax) for 30-40 minutes, aiming to improve their endurance. In order to arouse children’s motivation, enjoyable recreational games were included, such as jogging, walking, basketball, dodge-ball, and rope jumping.

All children received an evaluation of lung function, pulmonary function, sleep quality and inflammatory biomarkers at baseline and the end of twelve weeks of physical training.

Primary Outcome(s)

Effects of physical training measured using the lung function test, methacholine test, biochemical analysis (Cytokine assays and Lipoxin A4) and polysomnography at baseline and 12 weeks.

Secondary Outcome(s)

1. Anthropometric measures (weight, height, waist circumference and BMI Z-score) and demographic data (gender ratio, percentage of allergic rhinitis, duration of asthma history, age) are measured at baseline and 12 weeks
2. Pulmonary function is measured using spirometry and methacholine test at baseline and 12 weeks
3. Inflammatory biomarkers are measured using Bio-Plex Pro human Cytokine/Chemokine Panel kits (Bio-Rad) and the enzyme-linked immunosorbent assay (ELISA) at baseline and 12 weeks
4. Sleep quality is measured using polysomnography at baseline and 12 weeks

Secondary ID(s)

N/A

Source(s) of Monetary Support

China Medical University