Cardiovascular Risk FactorNCT03752060
The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women
A study testing Resistance Exercise and Aerobic Exercise in people with Cardiovascular Risk Factor and Menopause Related Conditions, run by Oklahoma State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor, Menopause Related Conditions, Neuromuscular Function
- What is being tested?
- Resistance Exercise and Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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?
Who cannot join
- are currently prescribed and/or taking lipid-lowering medications
- are participating in another clinical trial within thirty days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
192 Colvin Recreation Center
Stillwater, Oklahoma, 74074
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- 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
- Being tested
- Resistance Exercise, Aerobic Exercise
- Keywords
- post-menopause, women, post-prandial, metabolic function, cardiovascular function, muscle, body composition, angiogenesis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
Women assigned to the resistance exercise training group will complete progressive, full-body resistance exercise 3 times per week for 16 weeks.
Aerobic ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Participants will arrive in the laboratory following a 10 h overnight fast and having abstained from exercise for 48 h. An indwelling 24-gauge safelet catheter (Exel International; Redondo Beach, CA) will be inserted into a forearm vein by a phlebotomist (Dr. Emerson), and a slow infusion (~1 drip/s) of 0.9% NaCl solution will be initiated. A baseline blood draw will be taken to measure fasting metabolic and inflammatory markers. Next, participants will consume a HFM consisting of pie that is 63% fat, 34% carbohydrate, and 3% protein. The amount of pie consumed by each participant is based on body mass (12 kcal/kg). Participants will eat the same HFM pre- and post-intervention. Blood draws will be taken each hour for 6 h post-HFM to characterize the metabolic (TG, glucose, Total-C, HDL-C, LDL-C) and inflammatory and angiogenic (CRP, IL-6, IL-1β, VEGF-A, and VEGF-C) response.
Measured: A week 0 and immediately after the 16-week intervention period
Changes in Vascular Function
Flow-mediated dilation, which will be used to evaluate vascular function, will be assessed via Doppler ultrasound (Linear Array L745 and SonoScape A6 Portable Ultrasound Machine; Shenzhen, China) both fasting and 2 and 4 h post-HFM. After resting in a quiet, dark room for 15 minutes, the brachial artery will be scanned longitudinally slightly above the antecubital crease via a 12 MHz probe. A blood pressure cuff will be inflated to 230-250 mmHg on the proximal portion of the upper arm for 5 minutes, then suddenly released to induce hyperemia. Vascular measurements will be repeated 45-60 seconds after cuff deflation to determine FMD, which decreases following a HFM.
Measured: A week 0 and immediately after the 16-week intervention period
Changes in Body Composition
Height and weight will be measured and body composition assessed pre- and post-intervention using a DEXA scan (Hologic Discovery QDR; Marlborough, MA). Specific outcomes will include percent body fat, lean body mass, and abdominal adiposity.
Measured: A week 0 and immediately after the 16-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start15 Jan 2019
- Primary completion15 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752060
- Sponsor's protocol ID
- ED18101
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT03752060
- Acronym / sponsor ID
- ED18101
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Group | Experimental | Behavioral: Resistance ExerciseThese 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. |
| Aerobic Training Group | Active comparator | Behavioral: Aerobic ExerciseWomen 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. |
| 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- are currently prescribed and/or taking lipid-lowering medications
- are participating in another clinical trial within thirty days prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseWomen assigned to the resistance exercise training group will complete progressive, full-body resistance exercise 3 times per week for 16 weeks. | Behavioural | Resistance Training Group |
| Aerobic ExerciseWomen 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. | Behavioural | Aerobic Training Group |
Primary outcome
Change in Aerobic Capacity
Time frame: A week 0 and immediately after the 16-week intervention period
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.
3 secondary outcomes
Change in Metabolic and Inflammatory responses to a Meal Tolerance Test (MTT)
Time frame: A week 0 and immediately after the 16-week intervention period
Changes in Vascular Function
Time frame: A week 0 and immediately after the 16-week intervention period
Changes in Body Composition
Time frame: A week 0 and immediately after the 16-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Aerobic Exercise in people with Cardiovascular Risk Factor and Menopause Related Conditions, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aerobic Capacity (time frame: A week 0 and immediately after the 16-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.