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

Primary Purpose

Childhood Obesity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Resistance Exercise
Aerobic and Resistance Exercise
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital of Pittsburgh of UPMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Aerobic Exercise

Resistance Exercise

Aerobic and Resistance Exercise

Arm Description

Participants will perform aerobic exercise using treadmills and/or ellipticals at 40-65% of VO2peak, three times per week, for 60 minutes/session.

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.

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.

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Total and regional body composition
Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass
Cardiovascular disease risk factors
Carotid intima-media thickness, arterial stiffness, endothelial dysfunction

Full Information

First Posted
September 5, 2013
Last Updated
June 27, 2017
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01938950
Brief Title
Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)
Acronym
RCT:RCT
Official Title
Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
PI is leaving the institution
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 21, 2017 (Actual)
Study Completion Date
June 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Active Comparator
Arm Description
Participants will perform aerobic exercise using treadmills and/or ellipticals at 40-65% of VO2peak, three times per week, for 60 minutes/session.
Arm Title
Resistance Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerobic and Resistance Exercise
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Intervention Type
Other
Intervention Name(s)
Aerobic and Resistance Exercise
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total and regional body composition
Description
Total fat, visceral fat, intrahepatic lipid, skeletal muscle lipid, skeletal muscle mass
Time Frame
6 months
Title
Cardiovascular disease risk factors
Description
Carotid intima-media thickness, arterial stiffness, endothelial dysfunction
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SoJung Lee, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33739874
Citation
Yu WW, Lee S, Arslanian S, Tamim H, Kuk JL. Effects of Exercise on Resting Metabolic Rate in Adolescents with Overweight and Obesity. Child Obes. 2021 Jun;17(4):249-256. doi: 10.1089/chi.2020.0280. Epub 2021 Mar 18.
Results Reference
derived
PubMed Identifier
32674604
Citation
Kuk JL, Lee S. Assessing the utility of cardiorespiratory fitness, visceral fat, and liver fat in predicting changes in insulin sensitivity beyond simple changes in body weight after exercise training in adolescents. Appl Physiol Nutr Metab. 2021 Jan;46(1):55-62. doi: 10.1139/apnm-2020-0284. Epub 2020 Jul 16.
Results Reference
derived
PubMed Identifier
32674587
Citation
Lee S, Libman I, Hughan KS, Kuk JL, Barinas-Mitchell E, Chung H, Arslanian S. Effects of exercise modality on body composition and cardiovascular disease risk factors in adolescents with obesity: a randomized clinical trial. Appl Physiol Nutr Metab. 2020 Dec;45(12):1377-1386. doi: 10.1139/apnm-2019-0993.
Results Reference
derived
PubMed Identifier
31235380
Citation
Kuk JL, Lee S. Sex and Ethnic Differences in the Relationship between Changes in Anthropometric Measurements and Visceral Fat in Adolescents with Obesity. J Pediatr. 2019 Oct;213:121-127. doi: 10.1016/j.jpeds.2019.05.052. Epub 2019 Jun 22.
Results Reference
derived
PubMed Identifier
30554789
Citation
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.
Results Reference
derived

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

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