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

NCT03752060 | Completed

• 1 other identifier: ED18101
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Aerobic Capacity

  Participants will complete a maximal aerobic capacity test to determine VO2peak. The results of this test will be used to determine exercise intensity of the AT training condition, as well as serve as a primary end-point from pre- to post-intervention. In brief, participants will start the test at 25 W pedaling between 60-80 rpm, and the workload will be increased by 25 W each minute thereafter. Participants will exercise until they reach volitional fatigue, and can no longer maintain a pedal cadence greater than 60 rpm for 5 consecutive revolutions. Expired gases will be measured throughout the exercise testing via a metabolic cart and heart rate will be assessed using a wireless system.

  A week 0 and immediately after the 16-week intervention period

Secondary Outcomes (3)

• Change in Metabolic and Inflammatory responses to a Meal Tolerance Test (MTT)

  A week 0 and immediately after the 16-week intervention period

• Changes in Vascular Function

  A week 0 and immediately after the 16-week intervention period

• Changes in Body Composition

  A week 0 and immediately after the 16-week intervention period

Other Outcomes (2)

• Changes in Muscle Strength

  A week 0 and immediately after the 16-week intervention period

• Changes in Ultrasound-based Assessments of Muscle Size

  A week 0 and immediately after the 16-week intervention period

Study Arms (3)

Resistance Training Group

EXPERIMENTAL

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.

Behavioral: Resistance Exercise

Aerobic Training Group

ACTIVE COMPARATOR

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.

Behavioral: Aerobic Exercise

Control Group

NO INTERVENTION

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.

Interventions

Resistance Exercise BEHAVIORAL

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

Resistance Training Group

Aerobic Exercise 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.

Aerobic Training Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?
• Do you feel pain in your chest when you do physical activity?
• In the past month, have you had chest pain when you were not doing physical activity?
• Do you lose your balance because of dizziness or do you ever lose consciousness?
• Do you have a bone or joint problem that could be made worse by a change in physical activity?
• 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?

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

192 Colvin Recreation Center

Stillwater, Oklahoma, 74074, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: November 23, 2018
• Study Start: January 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 22, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

US (1)