Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
SoJung Lee, University of Pittsburgh Identifier:
First received: September 5, 2013
Last updated: April 28, 2017
Last verified: April 2017
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.

Condition Intervention
Childhood Obesity
Other: Aerobic Exercise
Other: Resistance Exercise
Other: Aerobic and Resistance Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 168
Study Start Date: October 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Other: Aerobic and Resistance Exercise


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01938950

United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: SoJung Lee, PhD University of Pittsburgh
  More Information

Responsible Party: SoJung Lee, Assistant Professor of Pediatrics, University of Pittsburgh Identifier: NCT01938950     History of Changes
Other Study ID Numbers: PRO12080401
1R01HL114857-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: September 5, 2013
Last Updated: April 28, 2017

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 24, 2017