Effects of Resistance and Aerobic Exercise on Cardiovascular Health (STRRIDE2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00275145
First received: January 10, 2006
Last updated: May 23, 2013
Last verified: November 2011

January 10, 2006
May 23, 2013
May 2004
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00275145 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effects of Resistance and Aerobic Exercise on Cardiovascular Health
Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE II)

This study will investigate the separate and combined effects of aerobic and resistance training on cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Heart Diseases
  • Obesity
  • Hyperlipidemia
  • Insulin Resistance
  • Metabolic Syndrome X
  • 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
  • Behavioral: Aerobic Exercise
    Exercise at 75% of maximal capacity for approximately 2 hours per week
  • Behavioral: Combo
    Lift weights (as described in RT group) and do aerobic exercise (as described in Aerobic group
  • Behavioral: Continued Sedentary lifestyle
    No changes
  • Experimental: Resistance Training
    8 months of Resistance Exercise Training
    Intervention: Behavioral: Resistance Training
  • Experimental: Aerobic Exercise
    8 months of Aerobic Exercise Training
    Intervention: Behavioral: Aerobic Exercise
  • Experimental: Combination RT & AT
    8 months of Combined Aerobic and Resistance Exercise Training
    Intervention: Behavioral: Combo
  • Experimental: Control
    Control/sedentary intervention
    Intervention: Behavioral: Continued Sedentary lifestyle

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
261
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275145
Pro00014514, R01HL057354, R01 HL57354, 0438
No
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: William E. Kraus Duke University
Duke University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP