Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/02/2012
Date assigned
24/02/2012
Last edited
12/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jong-Hwan Park

ORCID ID

Contact details

2-579-15
Mikajima
Tokorozawa
Saitama
359-1192
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A 12-week after-school physical activity improves endothelial cell function in overweight and obese children: a randomised controlled study

Acronym

Study hypothesis

A regular exercise programme for overweight children would elevate and improve the function of circulating endothelial progenitor cells.

Ethics approval

Dona-A university ethics committee - Busan, Rep. of Korea, 04/03/2010, ref : 2010/25

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

04/01/2010

Overall trial end date

07/01/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

Control (n = 14) or exercise (n = 15) groups

Participant exclusion criteria

1. Taking any medication
2. Participants with any disease

Recruitment start date

04/01/2010

Recruitment end date

07/01/2010

Locations

Countries of recruitment

Korea, South

Trial participating centre

2-579-15, Mikajima
Saitama
359-1192
Japan

Sponsor information

Organisation

Waseda University

Sponsor details

Tokorozawa
2-579-15
Mikajima
Saitama
359-1192
Japan

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22849607

Publication citations

  1. Results

    Park JH, Miyashita M, Kwon YC, Park HT, Kim EH, Park JK, Park KB, Yoon SR, Chung JW, Nakamura Y, Park SK, A 12-week after-school physical activity programme improves endothelial cell function in overweight and obese children: a randomised controlled study., BMC Pediatr, 2012, 12, 111, doi: 10.1186/1471-2431-12-111.

Additional files

Editorial Notes

12/10/2016: Plain English summary added.