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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
SoJung Lee, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01938950
First received: September 5, 2013
Last updated: October 31, 2013
Last verified: September 2013
  Purpose

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: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total and regional body composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass

  • Cardiovascular disease risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01938950

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: SoJung Lee, PhD    412-692-5147    sojung.lee@chp.edu   
Principal Investigator: SoJung Lee, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: SoJung Lee, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: SoJung Lee, Assistant Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01938950     History of Changes
Other Study ID Numbers: PRO12080401, 1R01HL114857-01A1
Study First Received: September 5, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014