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

This study has been terminated.

(PI is leaving the institution)

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

SoJung Lee, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01938950

First received: September 5, 2013

Last updated: June 27, 2017

Last verified: June 2017

History of Changes

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: 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:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by SoJung Lee, 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


Enrollment:	118
Study Start Date:	October 2013
Study Completion Date:	June 21, 2017
Primary Completion Date:	June 21, 2017 (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 (Child)
Sexes Eligible for Study:	All
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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01938950

Locations


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)

Investigators


Principal Investigator:	SoJung Lee, PhD	University of Pittsburgh

More Information


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 ( U.S. NIH Grant/Contract )
Study First Received:	September 5, 2013
Last Updated:	June 27, 2017

Additional relevant MeSH terms:


Pediatric Obesity Obesity Overnutrition Nutrition Disorders	Overweight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on July 13, 2017

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