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Physical Activity and Basal Metabolic Rate in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01550536
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : March 12, 2012
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Postmenopausal Metabolic Health Behavioral: Resistance and aerobic exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Aging and Basal Metabolic Rate in Postmenopausal Women: Effects of Long-Term and Short-Term Physical Activity
Study Start Date : January 2008
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
Behavioral: Resistance and aerobic exercise
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.
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.

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in fat-free mass [ Time Frame: baseline, 5, 10 and 16 weeks ]
  2. Change in maximal aerobic capacity [ Time Frame: baseline, 16 weeks ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550536

United States, California
La Jolla YMCA
La Jolla, California, United States, 92037
UCSD Human Exercise Physiology Laboratory
La Jolla, California, United States, 92093-0623
UCSD General Clinical Research Center
San Diego, California, United States, 92093-0990
Sponsors and Collaborators
University of California, San Diego
Wenner Gren
Sigma Xi
National Center for Research Resources (NCRR)
Principal Investigator: Andrew W Froehle, PhD University of California, San Diego
More Information

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]

Responsible Party: Andrew Froehle, Doctoral Candidate, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01550536     History of Changes
Other Study ID Numbers: UCSD GCRC 1910/6766
5M01RR000827-35 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Andrew Froehle, University of California, San Diego:
basal metabolic rate
resting energy expenditure
physical activity
metabolic syndrome