The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women

NCT ID: NCT03752060

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2019-11-22

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.

Conditions

Cardiovascular Risk Factor; Menopause Related Conditions; Neuromuscular Function; Aerobic Capacity; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistance Training Group

These participants will participate in a progressive resistance training program three times per week on non-consecutive days for 16 weeks. During each session, participants will perform the following exercises: supine bench press, lat pulldown, lateral raise, seated row, leg press, leg extension, leg curl, biceps curl, and triceps extension. The exercises will be completed such that upper body and lower body exercises are alternated throughout each session. During the Weeks 1-4 of training, the subjects will complete two sets of 15 repetitions for each exercise at approximately 50% of their one-repetition maximum (1RM). During Weeks 5-8 of training, the subjects will complete three sets of 12 repetitions at approximately 60% 1RM. During Weeks 9-12, the subjects will complete four sets of 12 repetitions at approximately 60% 1RM. During Weeks 13-16 of training, the subjects will complete 4 sets of 10 repetitions at approximately 70% 1RM.

Group Type: EXPERIMENTAL

Resistance Exercise

Intervention Type: BEHAVIORAL

Women assigned to the resistance exercise training group will complete progressive, full-body resistance exercise 3 times per week for 16 weeks.

Aerobic Training Group

Women randomized to the AT group will engage in aerobic exercise training that complies with ACSM recommendations10. Specifically, women will complete walking or stationary cycling sessions 5 times per week for 16 weeks. Heart rate data from the pre-intervention VO2peak tests (described below) will be used to estimate each participant's target training heart rate. Like the RT regimen, the AT intervention will be progressive in nature. During the first half of the intervention period, duration will increase by 5 minutes every 2 weeks, from 30 min to 45 min. In the second phase of the intervention, duration will remain constant at 45 min, but intensity will increase from 50% to 65% of heart rate reserve (HRR). Exercise sessions will take place on a treadmill and/or cycle ergometer.

Group Type: ACTIVE_COMPARATOR

Aerobic Exercise

Intervention Type: BEHAVIORAL

Women assigned to the aerobic exercise training group will complete progressive, aerobic exercise 5 times per week for 16 weeks. The aerobic training will progress first in duration, and then in intensity.

Control Group

The control group will complete all baseline and post-testing, but will not complete any training for the 16 weeks between the baseline and post-testing sessions. These participants will also be instructed to maintain their current dietary and physical activity habits (see Lifestyle Controls section). All participants in the control group will also be provided an opportunity to come to the laboratory for two weeks after they have completed the study to receive instruction regarding resistance and/or aerobic training exercise prescription, and to complete supervised resistance and/or aerobic exercise training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Resistance Exercise

Women assigned to the resistance exercise training group will complete progressive, full-body resistance exercise 3 times per week for 16 weeks.

Intervention Type: BEHAVIORAL

Aerobic Exercise

Women assigned to the aerobic exercise training group will complete progressive, aerobic exercise 5 times per week for 16 weeks. The aerobic training will progress first in duration, and then in intensity.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

192 Colvin Recreation Center

Stillwater, Oklahoma, United States

Countries

United States

Other Identifiers

ED18101

Identifier Type: -

Identifier Source: org_study_id