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Completed

NCT Number: NCT01550536

Physical Activity and Basal Metabolic Rate in Postmenopausal Women

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.

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Key information

Conditions

Postmenopausal Metabolic Health Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Motor Activity Nutritional and Metabolic Diseases

Age range

40 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

La Jolla YMCA, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance and Aerobic Exercise

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • Sigma Xi
  • Wenner Gren

Registry information

Official study title

Aging and Basal Metabolic Rate in Postmenopausal Women: Effects of Long-Term and Short-Term Physical Activity

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 12, 2012
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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