- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01550536
Physical Activity and Basal Metabolic Rate in Postmenopausal Women
November 27, 2023 updated by: Andrew Froehle, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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La Jolla, California, United States, 92037
- La Jolla YMCA
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La Jolla, California, United States, 92093-0623
- UCSD Human Exercise Physiology Laboratory
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San Diego, California, United States, 92093-0990
- UCSD General Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- naturally postmenopausal (i.e. non-surgically)/> 1 year since last menstruation
- FSH > 30 mIU/ml
- estradiol-17β < 25 pg/ml
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training
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.
|
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.
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No Intervention: Active
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in basal metabolic rate
Time Frame: baseline, 5, 10 and 16 weeks
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Basal metabolic rate is the energy expended at rest and under fasting conditions.
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baseline, 5, 10 and 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fat-free mass
Time Frame: baseline, 5, 10 and 16 weeks
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baseline, 5, 10 and 16 weeks
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Change in maximal aerobic capacity
Time Frame: baseline, 16 weeks
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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.
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baseline, 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew W Froehle, PhD, University of California, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
March 5, 2012
First Submitted That Met QC Criteria
March 9, 2012
First Posted (Estimated)
March 12, 2012
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UCSD GCRC 1910/6766
- 5M01RR000827-35 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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