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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00184236
Other study ID # ts-aet01
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated March 29, 2017
Start date February 2005
Est. completion date May 2008

Study information

Verified date March 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present study was to determine the effects of either a multidisciplinary approach or intensity-controlled interval training on cardiovascular risk factors in overweight adolescents.


Description:

Several approaches have been used to improve cardiovascular health status and quality of life in obese children and adolescents, without coming to a consensus decision. Recently, a few studies have determined the effects of exercise training and diet on endothelial function in overweight and obese children and adolescents. The main findings are that only a moderate amount of exercise training and diet changes improves or restores endothelial function. It is difficult, however, to asses the separate effects of the training and diet, particularly because none of the studies have used a homogenous exercise training regimen. Unanimously, better, but affordable prevention and treatment strategies to improve wide-scale health outcome are called upon to slow down the current epidemic of overweight. It is now well established that physical activity reduces, but does not currently prevent the epidemic of obesity from either reaching global proportions or taxing public health and economy. Despite the recent advances in understanding the responsible biology of improved cardiovascular health with exercise training, several lines of research questions are still unresolved. For instance, the optimal program, e.g. when to initiate, whom to prescribe exercise to, which exercise-intensity is required, and the actual design of the treatment program, remain by far yet to determine.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date May 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 16 Years
Eligibility Inclusion Criteria:

- Overweight and obese adolescents in the Trondheim area, referred to medical treatment at St. Olav's Hospital

Exclusion Criteria:

- Any coexisting medical illnesses

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multitreatment approach
12 months regimen consisting of group meetings every 2 weeks involving a physician, psychologist, physiotherapist and clinical nutritional physiologist. 21 h treatment during the first 3 months: 3 activity sessions (3 h) and 3 group conversations (4 h). Attendance inclusion criterium was set to minimum of 80%
Aerobic interval training
Walking/running 'uphill' on a treadmill twice a week for 3 months. 10 min warming-up at 70% of Hfmax before performing 4x4 intervals at 90-95% of Hfmax. 3 min active recovery at 70% of Hfmax between each interval. 5 min cool-down period, giving a total of 40 min.

Locations

Country Name City State
Norway The Norwegian University of Science and Technology Trondheim Sør-Trøndelag

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Ingul CB, Tjonna AE, Stolen TO, Stoylen A, Wisloff U. Impaired cardiac function among obese adolescents: effect of aerobic interval training. Arch Pediatr Adolesc Med. 2010 Sep;164(9):852-9. doi: 10.1001/archpediatrics.2010.158. — View Citation

Tjønna AE, Stølen TO, Bye A, Volden M, Slørdahl SA, Odegård R, Skogvoll E, Wisløff U. Aerobic interval training reduces cardiovascular risk factors more than a multitreatment approach in overweight adolescents. Clin Sci (Lond). 2009 Feb;116(4):317-26. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary VO2max change maximal oxygen uptake change 3 months and 12 months
Secondary Cardiovascular risk factors 2 years
Secondary endothelial function change measured as FMD (flow-mediated dilution) using high-resolution vascular ultrasound 3 months and 12 months
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