Postmenopausal Metabolic HealthNCT01550536
Physical Activity and Basal Metabolic Rate in Postmenopausal Women
A study testing Resistance and aerobic exercise in people with Postmenopausal Metabolic Health, run by University of California, San Diego at 3 sites in United States.
Trial summary
The primary purpose of this study is to expand research on the effects of physical activity on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training program. Read more about this study
- Who is it for?
- Ages 40 to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Metabolic Health
- What is being tested?
- Resistance and aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2008to Aug 2010
- 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 40 to 120 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- naturally postmenopausal (i.e. non-surgically)/> 1 year since last menstruation
- FSH > 30 mIU/ml
- estradiol-17β < 25 pg/ml
Who cannot join
- smoker, abuser of alcohol/other drugs
- hypo- or hyperthyroid (serum TSH < 0.3 or > 5.5 microU/ml, respectively)
- underweight or severely obese (BMI < 18.5 or > 35 kg/m2, respectively)
- weight instability within the past six months (±> 5% of body weight)
- hormone replacement therapy within the past six months
- history of metabolic, respiratory or cardiovascular disease
- high blood pressure
- contraindication for maximal aerobic testing as determined by PAR-Q questionnaire and physician's examination
Trial locations and contacts
3 sites in 1 country.
United States3 sites
La Jolla YMCA
La Jolla, California, 92037
UCSD Human Exercise Physiology Laboratory
La Jolla, California, 92093-0623
UCSD General Clinical Research Center
San Diego, California, 92093-0990
About this study
Official title: Aging and Basal Metabolic Rate in Postmenopausal Women: Effects of Long-Term and Short-Term Physical Activity
The primary purpose of this study is to expand research on the effects of physical activity on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training program. The investigators will measure BMR by indirect calorimetry and normalize it across subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will be compared: an intervention group (no previous participation in regular exercise, newly enrolled in this study's 16 week training program), and a long-term athlete group (have engaged in at least 5 hours of exercise per week for the past 10 years or longer). A secondary aim is to generate an equation for the prediction of BMR from fat free mass in physically active postmenopausal women, to be applied to hypotheses in biological anthropology. The investigators expect to find at baseline that, controlling for fat free mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention group. At 16 weeks the investigators expect no change in BMR for the long-term group, while BMR will have increased in the intervention group. At the same time, the investigators expect to find that after completing the training regimen, the intervention group will have BMR similar to that of the long-term athletes.
- Conditions
- Postmenopausal Metabolic Health
- Being tested
- Resistance and aerobic exercise
- Keywords
- basal metabolic rate, resting energy expenditure, menopause, physical activity, metabolic syndrome
- Medical subject headings
- Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance and aerobic exerciseBehavioural
Following baseline measurements, sedentary women were enrolled in a 16-week exercise training program at the YMCA in La Jolla, CA. Exercise occurred 3 times per week, for 1.5 hours each time. Exercise consisted of stretching, 20 minutes of aerobic exercise on elliptical machines, and 3 sets of 10-12 repetitions to failure for each of ten weight lifting exercises: abdominal crunch, arm curl, arm extension, chest press, lat pull-down, leg curl, leg extension, leg press, seated row, and trunk extension. Women started at 65-75% of 1-repetition-maximum, and resistance was increased as necessary to maintain the number of sets and reps and to continue to work to failure. Exercise was monitored by a TechnoGym electronic key system, and trainers instructed and supervised subjects in the gym.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Sedentary women who exercised <2 hours per week and who had never engaged in a regular exercise program were enrolled in an exercise training intervention, following baseline measurements. See intervention below. Receives: Behavioral: Resistance and aerobic exercise |
| Active | No intervention | Postmenopausal women who exercised >5 hours per week and had been doing so for at least the past 10 years. These women were asked to maintain their normal activity habits for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in basal metabolic rate
Basal metabolic rate is the energy expended at rest and under fasting conditions.
Measured: baseline, 5, 10 and 16 weeks
Secondary outcomes (2)
Change in fat-free mass
Measured: baseline, 5, 10 and 16 weeks
Change in maximal aerobic capacity
The maximal oxygen consumption achieved during a graded exercise test to exhaustion. Equipment: electronically-braked cycle ergometer. Participants were screened for CVD risk prior to testing by a physician. Lead II EKG was monitored during testing, and each test was overseen by a physician.
Measured: baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJan 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal Metabolic HealthStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Wenner Gren, Sigma Xi, National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Andrew Froehle, University of California, San Diego
- Investigators
- Andrew W Froehle, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550536
- Sponsor's protocol ID
- UCSD GCRC 1910/6766
- Other IDs
- 5M01RR000827-35
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2012
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Froehle AW, Ngo HT, Hopkins SR, Natarajan L, Schoeninger MJ. 2010. Relationship between physical activity, body composition and basal metabolic rate in postmenopausal women. Am J Hum Biol 22:252-253. [meeting abstract]
Froehle AW, Ngo HT, Natarajan L, Schoeninger MJ, Hopkins SR. 2011. Short-term exercise does not elevate basal metabolic rate (BMR) in postmenopausal women in the absence of increased fat free mass (FFM). Am J Hum Biol 23:259. [meeting abstract]
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging and Basal Metabolic Rate in Postmenopausal Women: Effects of Long-Term and Short-Term Physical Activity
- ClinicalTrials.gov ID
- NCT01550536
- Acronym / sponsor ID
- UCSD GCRC 1910/6766
- Conditions
- Postmenopausal Metabolic Health
- Keywords
- basal metabolic rate, resting energy expenditure, menopause, physical activity, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Wenner Gren, Sigma Xi, National Center for Research Resources (NCRR)
- Study start
- Jan 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Mar 2012 (estimated)
- 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.
The primary purpose of this study is to expand research on the effects of physical activity on basal metabolic rate (BMR) in healthy postmenopausal women, and to further compare the effects of long-term habitual exercise to the results of a shorter-term (16 weeks) training program. The investigators will measure BMR by indirect calorimetry and normalize it across subjects for body size (fat free mass) and level of aerobic fitness (VO2MAX). Two groups will be compared: an intervention group (no previous participation in regular exercise, newly enrolled in this study's 16 week training program), and a long-term athlete group (have engaged in at least 5 hours of exercise per week for the past 10 years or longer). A secondary aim is to generate an equation for the prediction of BMR from fat free mass in physically active postmenopausal women, to be applied to hypotheses in biological anthropology. The investigators expect to find at baseline that, controlling for fat free mass and VO2MAX, the long-term group will have significantly higher BMR than the intervention group. At 16 weeks the investigators expect no change in BMR for the long-term group, while BMR will have increased in the intervention group. At the same time, the investigators expect to find that after completing the training regimen, the intervention group will have BMR similar to that of the long-term athletes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Resistance and aerobic exerciseSedentary women who exercised <2 hours per week and who had never engaged in a regular exercise program were enrolled in an exercise training intervention, following baseline measurements. See intervention below. |
| Active | No intervention | –Postmenopausal women who exercised >5 hours per week and had been doing so for at least the past 10 years. These women were asked to maintain their normal activity habits for the duration of the study. |
Who may qualify
- Ages
- 40 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- naturally postmenopausal (i.e. non-surgically)/> 1 year since last menstruation
- FSH > 30 mIU/ml
- estradiol-17β < 25 pg/ml
Key exclusion criteria (8 listed)
- smoker, abuser of alcohol/other drugs
- hypo- or hyperthyroid (serum TSH < 0.3 or > 5.5 microU/ml, respectively)
- underweight or severely obese (BMI < 18.5 or > 35 kg/m2, respectively)
- weight instability within the past six months (±> 5% of body weight)
- hormone replacement therapy within the past six months
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 and aerobic exerciseFollowing baseline measurements, sedentary women were enrolled in a 16-week exercise training program at the YMCA in La Jolla, CA. Exercise occurred 3 times per week, for 1.5 hours each time. Exercise consisted of stretching, 20 minutes of aerobic exercise on elliptical machines, and 3 sets of 10-12 repetitions to failure for each of ten weight lifting exercises: abdominal crunch, arm curl, arm extension, chest press, lat pull-down, leg curl, leg extension, leg press, seated row, and trunk extension. Women started at 65-75% of 1-repetition-maximum, and resistance was increased as necessary to maintain the number of sets and reps and to continue to work to failure. Exercise was monitored by a TechnoGym electronic key system, and trainers instructed and supervised subjects in the gym. | Behavioural | Training |
Primary outcome
Change in basal metabolic rate
Time frame: baseline, 5, 10 and 16 weeks
Basal metabolic rate is the energy expended at rest and under fasting conditions.
2 secondary outcomes
Change in fat-free mass
Time frame: baseline, 5, 10 and 16 weeks
Change in maximal aerobic capacity
Time frame: baseline, 16 weeks
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 29 Nov 2023.
- Results publicationFroehle AW, Ngo HT, Hopkins SR, Natarajan L, Schoeninger MJ. 2010. Relationship between physical activity, body composition and basal metabolic rate in postmenopausal women. Am J Hum Biol 22:252-253. [meeting abstract]
- Results publicationFroehle AW, Ngo HT, Natarajan L, Schoeninger MJ, Hopkins SR. 2011. Short-term exercise does not elevate basal metabolic rate (BMR) in postmenopausal women in the absence of increased fat free mass (FFM). Am J Hum Biol 23:259. [meeting abstract]
Related trials for Postmenopausal Metabolic Health
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Not yet recruiting
Effects of Daily Avocado Consumption on Sleep and Skin Health in Postmenopausal Females
Poor Sleep Quality
Active, not recruiting
Menopausal Hormone Therapy, GLP-1 Agonists, and Glucose and Energy Homeostasis in Postmenopausal Women With Overweight/Obesity and Impaired Glucose Homeostasis
Menopause, Type 2 Diabetes
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Post Menopausal Osteoporosis
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.
Andrew W Froehle, PhD principal investigator
University of California, San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance and aerobic exercise in people with Postmenopausal Metabolic Health, run by University of California, San Diego at 3 sites 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 3 inclusion and 8 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 basal metabolic rate (time frame: baseline, 5, 10 and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01550536, which also lists 2 linked publications.
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 29 Nov 2023.