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Effects of Resistance and Aerobic Exercise on Cardiovascular Health

This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), October 2006

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00275145
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Obesity
Hyperlipidemia
Insulin Resistance
Metabolic Syndrome X
Behavioral: Physical Activity
Phase II

MedlinePlus related topics:   Exercise and Physical Fitness    Heart Diseases    Metabolic Syndrome    Obesity   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Efficacy Study
Official Title:   Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE II)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • capillary surface area (measured at Month 4, Year 1, and Year 1 plus 2 weeks)

Estimated Enrollment:   160
Study Start Date:   May 2004

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275145

Contacts
Contact: Chris A. Slentz, PhD     919-660-6743     slent002@mc.duke.edu    

Locations
United States, North Carolina
Duke University     Recruiting
      Durham, North Carolina, United States, 27708
      Contact: Chris A. Slentz, PhD     919-660-6743     slent002@mc.duke.edu    
      Study Chair: William E. Kraus            

Sponsors and Collaborators

Investigators
Study Chair:     William E. Kraus     Duke University    
  More Information

Study ID Numbers:   352, R01 HL57354
First Received:   January 10, 2006
Last Updated:   October 12, 2006
ClinicalTrials.gov Identifier:   NCT00275145
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Obesity
Heart Diseases
Hyperlipidemias
Metabolic Syndrome X
Metabolic Diseases
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Syndrome X
Nutrition Disorders
Overnutrition
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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