Women With Cancer: An Exercise Study to Promote Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102985
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : July 1, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University

January 19, 2010
April 13, 2010
July 1, 2015
January 2008
March 2013   (Final data collection date for primary outcome measure)
Bone mass-lumbar spine and hip (DEXA) [ Time Frame: baseline, 12 months ]
Serum biomarkers for bone (serum NTX and serum osteocalcin) will be drawn at baseline, 6 and 12 months. Bone mass for lumbar spine and hip will be measured by DEXA scan at baseline and 12 months.
Same as current
Complete list of historical versions of study NCT01102985 on Archive Site
body composition-% fat mass, % lean muscle mass (whole body DEXA) [ Time Frame: baseline, 6, 12 months ]
Body composition will be assessed by waist circumference and whole body DEXA scan (% fat mass, % lean muscle mass) at baseline, 6 and 12 months
Same as current
Not Provided
Not Provided
Women With Cancer: An Exercise Study to Promote Health
An Exercise Intervention to Improve Health in Postmenopausal Cancer Survivors
The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program compared to a home based physical activity program on bone mass, body composition, metabolic risk factors and cardiovascular fitness in women with cancer who have completed therapy.
The proposed study will evaluate an endurance-resistive exercise intervention to attenuate the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean muscle mass, weight gain, decreased physical activity) in an at-risk population of female cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma who have completed primary and/or adjuvant therapy within the past three years and who are perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise intervention (N=75) versus a health promotion control group (N=75). The specific aims of the study are to: (1) examine the effects of an exercise intervention on bone mass (serum biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist circumference), (2) examine the effect of an exercise intervention on metabolic risk factors (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood pressure), and (3) examine the effects of an exercise intervention on functional status and cardiovascular fitness (exercise stress test).
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Bone Loss
  • Cancer
  • Behavioral: aerobic resistance exercise
    three times per week aerobic resistance exercise for 12 months
    Other Name: physical activity
  • Behavioral: home based health promotion
    education and support to adapt national guidelines for 30 minutes physical activity most days of the week
    Other Name: health promotion
  • Experimental: aerobic resistance
    12 month aerobic resistance exercise at a fitness center
    Intervention: Behavioral: aerobic resistance exercise
  • Active Comparator: home based physical activity
    national recommendations for physical activity for adults
    Intervention: Behavioral: home based health promotion
Knobf MT, Jeon S, Smith B, Harris L, Thompson S, Stacy MR, Insogna K, Sinusas AJ. The Yale Fitness Intervention Trial in female cancer survivors: Cardiovascular and physiological outcomes. Heart Lung. 2017 Sep - Oct;46(5):375-381. doi: 10.1016/j.hrtlng.2017.06.001. Epub 2017 Aug 10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • Cancer diagnosis
  • Postmenopausal

Exclusion Criteria:

  • Health condition contraindication to moderate physical activity
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1R01CA122658-01A2 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Yale University
Yale University
National Cancer Institute (NCI)
Principal Investigator: M. Tish Knobf, PhD Yale University
Yale University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP