Physical Activity and Total Health Trial

Fred Hutchinson Cancer Center1 site in 1 country173 target enrollmentJanuary 1997

ConditionsBreast Cancer Prevention

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer Prevention
Sponsor: Fred Hutchinson Cancer Center
Enrollment: 173
Locations: 1
Primary Endpoint: Serum total estrone concentration
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goals of the study are to examine the effect in postmenopausal women of a one-year moderate intensity exercise intervention, as compared with a sedentary pattern (low-level stretching program), on: serum estrogens, androgens, sex hormone binding globulin, insulin, triglycerides, glucose, aromatase, FSH, LH, as well as parameters of body fat mass.

Registry

clinicaltrials.gov

Start Date

January 1997

End Date

December 2004

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fred Hutchinson Cancer Center

Eligibility Criteria

Inclusion Criteria

•Ages 55-75 years at first group meeting
•Physically able to undertake a moderate exercise program
•Sedentary activity pattern (exercising \< 2 times/week for 20 minutes at a level to produce sweating)
•Postmenopausal (not experiencing menstrual periods for the previous 12 months or FSH \>30 mIU/ml; for women who have had a hysterectomy, an FHS \>30 mIU/ml will classify them as postmenopausal)
•Body Mass Index (BMI) greater than 25.0
•Able to follow directions and fill out questionnaires, and exercise diaries and logs in English
•Agrees to be randomly assigned to either the exercise intervention or control group
•Gives informed consent to participate in all screening and study activities
•Able to come to the FHCRC for clinic visits and classes, to the UW Medical Center for CT scans, and to the UW NETT for measurements and instruction

Exclusion Criteria

•Plans to leave Western Washington within the follow-up period
•Using hormone replacement, tamoxifen, or oral contraceptives in past 6 months
•Currently having severe hot flashes (that might prompt participant to start hormone replacement therapy before the end of study)
•Current unstable thyroid disease or unstable dose of thyroid medications or TSH \>5.0 IU/ml or \<0.5 IU/ml
•Invasive cancer in the past 10 years (except nonmelanotic skin cancer)
•Any other endocrinologic abnormality
•Breast, endometrial, ovarian, or melanoma cancer or carcinoma-in-situ at any time
•Morbidly obese (BMI \> 40)
•Current or planned use of corticosteroids
•Currently on or planning to enter a structured weight loss program or to take diet drugs

Outcomes

Primary Outcomes

Serum total estrone concentration

Time Frame: Baseline, 3 month, 12-month

Secondary Outcomes

serum total estradiol, free estradiol, estrone sulfate, testosterone, androstenedione, and sex hormone binding globulin (SHBG).(baseline, 3 month, 12-month)
Urinary estrogen metabolite ratio (2-OHE1:16alpha-OHE1).(Basline, 3 month, 12-month)
Adipose tissue stores: weight, body mass index, total fat mass, waist and hip circumferences and their ratio, and subcutaneous and intra-abdominal fat areas(Baseline, 3 month, 12 month)
Fasting serum concentrations of insulin, glucose, and triglycerides(Baseline, 3 month, 12 month)
Quality of life(Baseline, 3 month, 12 month)