NCT01550536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

March 5, 2012

Last Update Submit

November 27, 2023

Conditions

Keywords

basal metabolic rateresting energy expendituremenopausephysical activitymetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in basal metabolic rate

    Basal metabolic rate is the energy expended at rest and under fasting conditions.

    baseline, 5, 10 and 16 weeks

Secondary Outcomes (2)

  • Change in fat-free mass

    baseline, 5, 10 and 16 weeks

  • Change in maximal aerobic capacity

    baseline, 16 weeks

Study Arms (2)

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.

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.

Interventions

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.

Training

Eligibility Criteria

Age40 Years - 120 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • naturally postmenopausal (i.e. non-surgically)/\> 1 year since last menstruation
  • FSH \> 30 mIU/ml
  • estradiol-17β \< 25 pg/ml

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

La Jolla YMCA

La Jolla, California, 92037, United States

Location

UCSD Human Exercise Physiology Laboratory

La Jolla, California, 92093-0623, United States

Location

UCSD General Clinical Research Center

San Diego, California, 92093-0990, United States

Location

Related Publications (2)

  • 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]

    RESULT
  • 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]

    RESULT

MeSH Terms

Conditions

Motor ActivityMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Andrew W Froehle, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 12, 2012

Study Start

January 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations