A 12-week after-school physical activity improves endothelial cell function in overweight and obese children
| ISRCTN | ISRCTN19037201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19037201 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/02/2012
- Registration date
- 24/02/2012
- Last edited
- 12/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The arteries of obese children could be just as clogged as those of middle-aged people. This build-up (atherosclerosis) could put children at risk for strokes or heart disease as early as age 30. Therefore, lifestyle changes and preventative measures are necessary to reduce and prevent childhood obesity. Endothelial progenitor cells (EPCs) are a type of cell involved in the regeneration of the lining of blood vessels. Regular physical exercise has been shown to mobilise EPCs from the bone marrow, which then participate in the repair of blood vessels and the formation of new vessels. The aim of this study is to investigate the effects of an after-school aerobic and resistance exercise programme on EPCs in overweight and obese children.
Who can participate?
Overweight and obese children aged 12-13
What does the study involve?
Participants are randomly allocated to either the exercise group or the control group. Participants in the control group are advised to maintain their usual activities of daily living during the study. The exercise group participate in a 12-week exercise programme consisting of combined aerobic and resistance exercise on 3 days per week (i.e., Monday, Wednesday and Friday). Each 80-minute exercise programme includes 10 minutes of warm-up activities and 10 minutes of cool-down activities after school. All training sessions are supervised by two experienced trainers. At the start and the end of the study both groups provide blood samples which are used to measure the levels of blood cells including EPCs. Both groups also undergo the carotid intima-media thickness test, which measures the thickness of the inner two layers of the carotid artery, a marker of heart disease and early atherosclerosis.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
1. Dong-A University and Cell Therapy Research Center (South Korea)
2. Research Institute of Bioscience and Biotechnology (South Korea)
When is the study starting and how long is it expected to run for?
March to July 2010
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mr Jong-Hwan Park
Contact information
Scientific
2-579-15, Mikajima
Tokorozawa
Saitama
359-1192
Japan
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A 12-week after-school physical activity improves endothelial cell function in overweight and obese children: a randomised controlled study |
| Study objectives | A regular exercise programme for overweight children would elevate and improve the function of circulating endothelial progenitor cells. |
| Ethics approval(s) | Dona-A university ethics committee - Busan, Rep. of Korea, 04/03/2010, ref : 2010/25 |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Children randomised to the exercise group or the control group. The 12-week exercise programme intervention consisted of 3 days of combined aerobic and resistance exercise per week (i.e., Monday, Wednesday and Friday). Each 80-minute exercise programme included 10 minutes of warm-up activities and 10 minutes of cool-down activities after school. All training sessions were supervised by two experienced trainers. 1. Aerobic exercise consisted of 30 minutes of treadmill walking and/or running at 50-70% of the heart rate reserve (HRR). Participants performed the exercise programme for 30 minutes at 50-60% of the HRR during weeks 1 through 6. After week 6, the emphasis was placed on reaching and maintaining an exercise intensity of approximately 60-70% of the HRR for 30 minutes. 2. Resistance exercise consisted of two rotations of a circuit of seven exercises with less than 30 seconds of rest between exercises. Participants trained on the same equipment used for the 60% of one repetition maximum at 8-12 repetition assessments. Each section included the following dynamic exercises: bench presses, biceps curls, triceps extensions, leg presses, leg extensions, leg curls and calf raises. |
| Intervention type | Behavioural |
| Primary outcome measure | Percentage of CD34+, CD133+ and endothelial progenitor cells (EPCs) (CD34+/CD133+) at baseline and 12 weeks |
| Secondary outcome measures | 1. Body mass index and cardiorespiratory fitness at baseline and 12 weeks 2. Concentrations of lipid parameters and inflammatory markers at baseline and 12 weeks 3. Carotid intima-media thickness at baseline and 12 weeks |
| Overall study start date | 04/01/2010 |
| Completion date | 07/01/2010 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | Control (n = 14) or exercise (n = 15) groups |
| Key inclusion criteria | 1. Overweight and obese were defined as having a body mass index ≥ the 85th percentile for age and gender, according to the WHO mass index cut-off point 2. Aged 12-13 years, boys and girls 3. Written consent from parents |
| Key exclusion criteria | 1. Taking any medication 2. Participants with any disease |
| Date of first enrolment | 04/01/2010 |
| Date of final enrolment | 07/01/2010 |
Locations
Countries of recruitment
- Japan
- Korea, South
Study participating centre
359-1192
Japan
Sponsor information
University/education
Tokorozawa
2-579-15, Mikajima
Saitama
359-1192
Japan
"ROR" |
https://ror.org/00ntfnx83 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/07/2012 | Yes | No |
Editorial Notes
12/10/2016: Plain English summary added.
