Effects of Resistance and Aerobic Exercise on Cardiovascular Health (STRRIDE2)
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ClinicalTrials.gov Identifier: NCT00275145 |
Recruitment Status :
Completed
First Posted : January 11, 2006
Last Update Posted : May 24, 2013
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Diseases Heart Diseases Obesity Hyperlipidemia Insulin Resistance Metabolic Syndrome X | Behavioral: Resistance Training Behavioral: Aerobic Exercise Behavioral: Combo Behavioral: Continued Sedentary lifestyle | Phase 2 |
BACKGROUND:
Substantial evidence supports a favorable relationship between cardiovascular fitness, physical activity, and cardiovascular health. In particular, it is well established that increased levels of physical activity result in favorable improvements in lipid and carbohydrate metabolism. There is also evidence that increased physical activity and cardiovascular fitness have beneficial effects on cardiovascular health, independent of the effects on specific cardiovascular risk factors. One hypothesis proposes that the beneficial effects of regular exercise in humans is mediated through peripheral mechanisms, in particular through the chronic adaptations in skeletal muscle to habitual exercise. The exercise exposure required to achieve health benefits is poorly defined and the mechanisms through which these beneficial adaptations occur are poorly understood. This study will investigate the peripheral biological mechanisms through which chronic physical activity alters carbohydrate metabolism and lipid metabolism, resulting in improvements in these parameters of cardiovascular health and fitness.
DESIGN NARRATIVE:
In Studies of a Targeted Risk Reduction Intervention through Defined Exercise II (STRRIDE II), participants will be randomly assigned to one of four exercise training regimens after a 4-month sedentary control period. After an initial ramp period of up to 2 months, participants will be asked to train for 6 months in a given exercise program. The programs differ either in the dose of aerobic exercise or in the mode (e.g., aerobic exercise, resistance exercise, or a combination). Parameters reflecting changes in carbohydrate and lipid metabolism will be studied at an integrative physiologic level and with measurable biological endpoints in peripheral skeletal muscle (capillary surface area). It is proposed that the elucidation of the peripheral mechanisms mediating the favorable responses in carbohydrate and lipid metabolism to chronic physical activity will lead to better understanding of the health benefits conferred by physical activity and cardiovascular fitness. This may also point the way toward better exercise recommendations for clients with significant cardiovascular risk factors. The purpose of this study is to investigate the peripheral biological mechanisms through which chronic physical activity will alter carbohydrate metabolism and lipid metabolism that results in improvement in parameters of cardiovascular health and fitness. The driving hypothesis is that the health benefits derived from habitual exercise are primarily mediated through adaptations occurring in skeletal muscle. The mechanism of change in skeletal muscle differs by the mode of exercise training. It is hypothesized that the health benefits of aerobic exercise are mediated primarily by qualitative changes in skeletal muscles (alterations in exposed capillary surface area in skeletal muscle induced by exercise training) and that the health benefits of resistance exercise are mediated primarily by quantitative changes in skeletal muscles (alterations in fiber area in skeletal muscle induced by exercise training). The investigators will use combination exercise regimens in moderately obese patients with mild to moderate lipid metabolic abnormalities in order to investigate whether induced alterations in skeletal muscle fiber area, metabolic capacity, and capillary surface area account for favorable alterations in insulin sensitivity, glucose metabolism, lipoprotein levels, and lipid metabolism.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 261 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE II) |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
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Experimental: Resistance Training
8 months of Resistance Exercise Training
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Behavioral: Resistance Training
Lifting weights 3 times per week; 8 different exercise each time; for each exercise, do three sets = lifting an appropriate weight between 8-12 for each set; rest 45 seconds (at least) between sets |
Experimental: Aerobic Exercise
8 months of Aerobic Exercise Training
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Behavioral: Aerobic Exercise
Exercise at 75% of maximal capacity for approximately 2 hours per week |
Experimental: Combination RT & AT
8 months of Combined Aerobic and Resistance Exercise Training
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Behavioral: Combo
Lift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group |
Experimental: Control
Control/sedentary intervention
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Behavioral: Continued Sedentary lifestyle
No changes |
- Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity [ Time Frame: Month 0, Month 4, Year 1, and Year 1 plus 2 weeks ]
- Metabolic Syndrome (ATP III defined); Maximal Oxygen consumption; muscle biopsy measures (oxidative enzymes, capillary density, myofiber diameter) [ Time Frame: 0 mths, 4 mths, 1 year and 1 year and 2 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sedentary (exercises fewer than two times per week)
- Overweight or mildly obese (body mass index [BMI] of 25 to 35 kg/m2) with mild to moderate lipid abnormalities (either LDL cholesterol 130 to 190 mg/dl or HDL cholesterol less than 40 mg/dl for men or 5 less than 45 mg/dl for women)
Exclusion Criteria:
- Diabetes
- Hypertension
- Other metabolic or musculoskeletal diseases
- Current use of or intent to diet
- Use of confounding medication
- Overt presence of coronary heart disease
- Unwilling to be randomized to any group

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275145
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 |
Study Chair: | William E. Kraus | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00275145 |
Other Study ID Numbers: |
Pro00014514 R01HL057354 ( U.S. NIH Grant/Contract ) 0438 ( Other Identifier: Duke legacy IRB number ) |
First Posted: | January 11, 2006 Key Record Dates |
Last Update Posted: | May 24, 2013 |
Last Verified: | November 2011 |
Cardiovascular Diseases Heart Diseases Metabolic Syndrome Insulin Resistance Hyperlipidemias |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Dyslipidemias Lipid Metabolism Disorders |