Clinical trial NCT03752060: The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women
Official title: The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Menopause Related Conditions
Neuromuscular Function
Aerobic Capacity
Inflammation
Keywords: post-menopause
women
post-prandial
metabolic function
cardiovascular function
muscle
body composition
angiogenesis
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 68
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following enrollment, participants will complete familiarization and be randomly assigned to an aerobic training (AT; n = 20), a resistance training (RT; n = 20), or a control (CON; n = 20) group.
Primary purpose: TREATMENT

Brief summary: Given the heightened cardiovascular disease (CVD) risk in post-menopausal women, studies are needed to explore novel, feasible methods for reducing risk in this population. Based on prior data, primarily in other populations, progressive resistance training is a promising candidate. This project will test the effectiveness of a practical, progressive resistance training regimen for lowering numerous CVD risk factors compared to both aerobic training and no exercise in post-menopausal women.

Detailed description: The number of women living with cardiovascular disease (CVD) is greater than for men and CVD is the leading cause of death for women. Post-menopausal women are a particularly vulnerable population in terms of adverse cardiovascular indicators and outcomes. Specifically, they exhibit greater visceral adipose tissue, fasting and postprandial glucose, total cholesterol (Total-C), fasting insulin, and systolic blood pressure, and are at increased risk for coronary heart disease compared to pre-menopausal women. There is also evidence that cardiovascular indicators (i.e., triglycerides, low high-density lipoprotein cholesterol (HDL-C), etc) are stronger risk predictors in women than men. Despite the staggering rates of CVD in post-menopausal women, as noted by the American Heart Association (AHA), CVD remains understudied in this population. Numerous studies have demonstrated the cardioprotective effects of exercise. However, these studies have largely featured younger individuals, primarily men, undergoing aerobic exercise training. Findings in recent years have indicated the potential benefits of resistance training beyond improving muscular size or strength, such as improved aerobic fitness, central adiposity, glycemic control, and cholesterol profiles. However, large clinical gaps have been noted for women with regard to the effects of resistance training on cardiovascular health. Thus, there is a clear need to assess the cardioprotective effects of progressive exercise training in post-menopausal women.

SPECIFIC AIMS:

1. To test the hypothesis that realistic full-body progressive resistance training improves markers of (a) cardiovascular health and (b) body composition and muscular health in post-menopausal women versus a low physical-activity control.

   A. The primary markers of cardiovascular health to be assessed are aerobic capacity, fasting and postprandial metabolic and inflammatory responses, vascular function via flow-mediated dilation (FMD) and markers of angiogenesis.

   B. The primary body composition and muscle function variables to be assessed are muscle size, isometric and dynamic muscle strength, lean body mass, percent body fat, and abdominal adiposity.
2. To compare the effects of realistic, full-body progressive resistance training in post-menopausal women versus moderate-intensity aerobic exercise, the standard exercise prescription for cardiovascular health, on the cardiovascular, body composition, and muscular health outcomes listed above in 1A. and B.

Eligibility criteria: Inclusion Criteria:

* provide written and dated informed consent to participate in the study; (2) be willing and able to comply with the protocol
* be willing and able to comply with the protocol
* be a female between the ages of 45 and 65, inclusive
* be postmenopausal for ≥ 1 year
* be in good health and free from chronic cardiovascular, pulmonary, or musculoskeletal disease as determined by a health history questionnaire
* have a BMI between 18.5 and 40.0, inclusive; and
* answer no to all questions on the PAR-Q for people aged 15 to 69, which are as follows:

  1. Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
  2. Do you feel pain in your chest when you do physical activity?
  3. In the past month, have you had chest pain when you were not doing physical activity?
  4. Do you lose your balance because of dizziness or do you ever lose consciousness?
  5. Do you have a bone or joint problem that could be made worse by a change in physical activity?
  6. Is your doctor currently prescribing drugs for your blood pressure or heart condition? Do you know of any other reason why you should not do physical activity?

Exclusion Criteria:

* are currently prescribed and/or taking lipid-lowering medications
* are participating in another clinical trial within thirty days prior to enrollment

Primary outcomes:
measure: Change in Aerobic Capacity
timeFrame: A week 0 and immediately after the 16-week intervention period
Secondary outcomes:
measure: Change in Metabolic and Inflammatory responses to a Meal Tolerance Test (MTT)
timeFrame: A week 0 and immediately after the 16-week intervention period
measure: Changes in Vascular Function
timeFrame: A week 0 and immediately after the 16-week intervention period
measure: Changes in Body Composition
timeFrame: A week 0 and immediately after the 16-week intervention period
Other outcomes:
measure: Changes in Muscle Strength
timeFrame: A week 0 and immediately after the 16-week intervention period
measure: Changes in Ultrasound-based Assessments of Muscle Size
timeFrame: A week 0 and immediately after the 16-week intervention period
Locations:
city: Stillwater
country: United States
facility: 192 Colvin Recreation Center
state: Oklahoma
Study officials:
References: