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Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT) (RCT:RCT)

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ClinicalTrials.gov Identifier: NCT01938950
Recruitment Status : Terminated (PI is leaving the institution)
First Posted : September 10, 2013
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
SoJung Lee, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 5, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date June 28, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date June 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Insulin sensitivity [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01938950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
  • Total and regional body composition [ Time Frame: 6 months ]
    Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass
  • Cardiovascular disease risk factors [ Time Frame: 6 months ]
    Carotid intima-media thickness, arterial stiffness, endothelial dysfunction
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass [ Time Frame: 6 months ]
  • Carotid intima-media thickness, arterial stiffness, endothelial dysfunction [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)
Official Title  ICMJE Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)
Brief Summary The current epidemic rate of childhood obesity is a leading health concern as overweight/obese youth may suffer from comorbid conditions, once considered exclusive to adults. It has been suggested that physical inactivity is a major determinant of obesity and obesity-related health risk in children and adolescents. Recent studies in adults report that the combination of aerobic and resistance exercise is a better strategy than aerobic or resistance exercise alone for reducing risk factors for type 2 diabetes. Currently, the most effective exercise modality for concurrent reductions of adiposity, in particular abdominal fat, and risk factors for type 2 diabetes and cardiovascular disease (CVD) is unknown in adolescents. Therefore, we will employ a randomized trial to examine the effects of a long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and skeletal muscle, and 3) traditional and non-traditional risk factors/markers for CVD in overweight boys and girls. We will recruit 168 sedentary overweight (BMI >85th percentile) adolescent boys and girls aged 12-17 years old and randomly assign them to one of three 6-month intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2) resistance exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week) group. A weight maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will be prescribed and monitored for all groups, so that any changes in energy balance will be induced by exercise intervention alone (e.g., no calorie restriction). We believe that this proposed application will have a significant implication that is directly relevant for one in three American adolescents who are at increased risk of developing obesity-related co-morbidities.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Childhood Obesity
Intervention  ICMJE
  • Other: Aerobic Exercise
  • Other: Resistance Exercise
  • Other: Aerobic and Resistance Exercise
Study Arms  ICMJE
  • Active Comparator: Aerobic Exercise
    Participants will perform aerobic exercise using treadmills and/or ellipticals at 40-65% of VO2peak, three times per week, for 60 minutes/session.
    Intervention: Other: Aerobic Exercise
  • Active Comparator: Resistance Exercise
    Participants will perform 2 sets (8-12 repetitions per set) of 8 exercises to the point of failure using weight stack equipment, three times per week, for 60 minutes/session. 2 sets of push-ups and sit-ups will also be performed.
    Intervention: Other: Resistance Exercise
  • Active Comparator: Aerobic and Resistance Exercise
    Participants will perform aerobic exercise using treadmills and/or ellipticals for 30 min at 40-65% of VO2peak and thereafter, perform 1 set of each of the above 10 resistance exercise for 30 min.
    Intervention: Other: Aerobic and Resistance Exercise
Publications * Lee S, Libman I, Hughan K, Kuk JL, Jeong JH, Zhang D, Arslanian S. Effects of Exercise Modality on Insulin Resistance and Ectopic Fat in Adolescents with Overweight and Obesity: A Randomized Clinical Trial. J Pediatr. 2019 Mar;206:91-98.e1. doi: 10.1016/j.jpeds.2018.10.059. Epub 2018 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 27, 2017)
118
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
168
Actual Study Completion Date  ICMJE June 21, 2017
Actual Primary Completion Date June 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age 12-17 years

  • BMI percentile for age and sex >-85% percentile and BMI <40 kg/m2
  • No structured physical activity in the past 3 months prior to the study (not including school physical education classes)
  • No significant weight changes (>2-3 kg/m2) in the past 3 months prior to the study

Exclusion Criteria:

  • Endocrine disorders (e.g., polycystic ovary syndrome, diabetes)
  • Syndromic obesity
  • Positive pregnancy test
  • Use of chronic medications which influence glucose metabolism and body composition
  • Chronic medical/psychiatric conditions preventing the ability to participate in the study.
  • Anemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938950
Other Study ID Numbers  ICMJE PRO12080401
1R01HL114857-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SoJung Lee, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: SoJung Lee, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP